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Effect of Serelaxin Versus Standard of Care in Acute Heart Failure (AHF) Patients (RELAX-AHF-EU)

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ClinicalTrials.gov Identifier: NCT02064868
Recruitment Status : Terminated (Study was terminated based on results from pivotal adult AHF study CRLX030A2301)
First Posted : February 17, 2014
Results First Posted : March 22, 2019
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acute Heart Failure (AHF)
Interventions Drug: Serelaxin
Drug: Standard of Care
Enrollment 2666
Recruitment Details  
Pre-assignment Details The initial target was to randomize 3183 patients. This study was prematurely terminated (due to the neutral read-out of study RELAX-AHF-2) after 2666 patients were randomized. 16 patients had not qualified for randomization but were inadvertently randomized. These 16 patients did not enter the treatment phase and were not counted as started.
Arm/Group Title Serelaxin + Standard of Care Standard of Care (SOC)
Hide Arm/Group Description Serelaxin (30 µg/kg/day) as continuous 48 hour intravenous infusion plus standard of care. All patients were required to receive standard of care background heart failure (HF) management during the study, according to local guidelines/international standards. This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.
Period Title: Overall Study
Started [1] 1756 894
Full Analysis Set 1756 894
Safety Set 1729 [2] 894
Per Protocol Set 1155 627
Completed 1722 881
Not Completed 34 13
Reason Not Completed
Lost to Follow-up             14             8
Physician Decision             1             0
Withdrawal by Subject             14             3
Technical Problems or Missing             5             2
[1]
All Randomized Participants
[2]
The Safety Set includes one patient not randomized but treated with serelaxin
Arm/Group Title Serelaxin + Standard of Care Standard of Care (SOC) Total
Hide Arm/Group Description Serelaxin (30 µg/kg/day) as continuous 48 hour intravenous infusion plus standard of care. All patients were required to receive standard of care background heart failure (HF) management during the study, according to local guidelines/international standards. This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc. Total of all reporting groups
Overall Number of Baseline Participants 1756 894 2650
Hide Baseline Analysis Population Description
Full Analysis Set
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1756 participants 894 participants 2650 participants
75.24  (10.349) 75.95  (9.905) 75.48  (10.205)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1756 participants 894 participants 2650 participants
Female
760
  43.3%
383
  42.8%
1143
  43.1%
Male
996
  56.7%
511
  57.2%
1507
  56.9%
[1]
Measure Analysis Population Description: Full Analysis Set
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1756 participants 894 participants 2650 participants
Caucasian
1706
  97.2%
869
  97.2%
2575
  97.2%
Black
4
   0.2%
4
   0.4%
8
   0.3%
Asian
5
   0.3%
2
   0.2%
7
   0.3%
Unknown
16
   0.9%
7
   0.8%
23
   0.9%
Other
25
   1.4%
12
   1.3%
37
   1.4%
[1]
Measure Analysis Population Description: Full Analysis Set
1.Primary Outcome
Title Percentage of Participants With Worsening Heart Failure (WHF) / All Cause of Deaths Through Day 5
Hide Description In-hospital WHF through Day 5 post-randomization included worsening signs and/or symptoms of heart failure that required an intensification of intravenous therapy for heart failure or mechanical ventilation, renal or circulatory support. A central event adjudication committee was appointed to oversee the WHF primary endpoint adjudication.
Time Frame 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Serelaxin + Standard of Care Standard of Care (SOC)
Hide Arm/Group Description:
Serelaxin (30 µg/kg/day) as continuous 48 hour intravenous infusion plus standard of care.
All patients were required to receive standard of care background heart failure (HF) management during the study, according to local guidelines/international standards. This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.
Overall Number of Participants Analyzed 1756 894
Measure Type: Number
Unit of Measure: Percentage of Participants
4.95 6.94
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Serelaxin + Standard of Care, Standard of Care (SOC)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0172
Comments One-sided p-value
Method Gehan’s generalized Wilcoxon test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.71
Confidence Interval (2-Sided) 95%
0.51 to 0.98
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With In-hospital Worsening Heart Failure/All-Cause Death/Readmission for Heart Failure Through Day 14
Hide Description WHF/death/readmission for heart failure through Day 14. WHF/deaths through Day 5 were adjudicated and confirmed by the Clinical Endpoint Committee, WHF/deaths after Day 5 through Day 14 and readmission through Day 14 were as reported by the investigators.
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Serelaxin + Standard of Care Standard of Care (SOC)
Hide Arm/Group Description:
Serelaxin (30 µg/kg/day) as continuous 48 hour intravenous infusion plus standard of care.
All patients were required to receive standard of care background heart failure (HF) management during the study, according to local guidelines/international standards. This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.
Overall Number of Participants Analyzed 1756 894
Measure Type: Number
Unit of Measure: Percentage of Patients
8.49 10.63
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Serelaxin + Standard of Care, Standard of Care (SOC)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0634
Comments Two-sided p-value
Method Gehan’s generalized Wilcoxon test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.79
Confidence Interval (2-Sided) 95%
0.61 to 1.02
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With Persistent Sign or Symptoms of Heart Failure / Non-Improvement at Any Post Baseline Visit Through Day 5
Hide Description Persistent or non-improvement in any signs or symptoms of HF at any post baseline visit up to Day 5.
Time Frame 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (only evaluable patients with non-missing information included)
Arm/Group Title Serelaxin + Standard of Care Standard of Care (SOC)
Hide Arm/Group Description:
Serelaxin (30 µg/kg/day) as continuous 48 hour intravenous infusion plus standard of care.
All patients were required to receive standard of care background heart failure (HF) management during the study, according to local guidelines/international standards. This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.
Overall Number of Participants Analyzed 1744 894
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
86
(84 to 87)
91
(89 to 93)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Serelaxin + Standard of Care, Standard of Care (SOC)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With Renal Deterioration at Any Post Baseline Visit Through Day 14
Hide Description Renal deterioration is defined as > or = 0.3 mg/dL increase from screening in serum creatinine.
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (only evaluable patients with non-missing information included)
Arm/Group Title Serelaxin + Standard of Care Standard of Care (SOC)
Hide Arm/Group Description:
Serelaxin (30 µg/kg/day) as continuous 48 hour intravenous infusion plus standard of care.
All patients were required to receive standard of care background heart failure (HF) management during the study, according to local guidelines/international standards. This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.
Overall Number of Participants Analyzed 1740 889
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
36
(34 to 38)
44
(40 to 47)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Serelaxin + Standard of Care, Standard of Care (SOC)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
5.Secondary Outcome
Title Length of Index Hospital Stay
Hide Description Length of stay (in hours) is defined as the index hospitalization discharge date and time minus the index hospitalization start date and time.
Time Frame 30 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Serelaxin + Standard of Care Standard of Care (SOC)
Hide Arm/Group Description:
Serelaxin (30 µg/kg/day) as continuous 48 hour intravenous infusion plus standard of care.
All patients were required to receive standard of care background heart failure (HF) management during the study, according to local guidelines/international standards. This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.
Overall Number of Participants Analyzed 1756 894
Mean (Standard Deviation)
Unit of Measure: hours
251.28  (162.368) 243.59  (160.270)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Serelaxin + Standard of Care, Standard of Care (SOC)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1392
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants With Adverse Events as Assessment of Safety and Tolerability of Serelaxin in AHF Patients
Hide Description [Not Specified]
Time Frame Adverse Events (AE): 5 Days / Serious Adverse Events (SAE): 14 days / All cause deaths 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set
Arm/Group Title Serelaxin + Standard of Care Standard of Care (SOC)
Hide Arm/Group Description:
Serelaxin (30 µg/kg/day) as continuous 48 hour intravenous infusion plus standard of care.
All patients were required to receive standard of care background heart failure (HF) management during the study, according to local guidelines/international standards. This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.
Overall Number of Participants Analyzed 1729 894
Measure Type: Number
Unit of Measure: Percentage of participants
Patients with any AE through Day 5 58.13 56.04
Patients with any SAE through Day 14 12.38 11.97
All cause deaths through Day 5 0.58 0.67
All cause deaths through Day 14 1.91 2.01
All cause deaths through Day 30 3.30 4.25
7.Secondary Outcome
Title Change From Baseline in Health-related Quality of Life Index Value, Assessed by EuroQoL EQ-5D-5L Questionnaire.
Hide Description EQ-5D-5L is a questionnaire designed to assess health status in adults consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). The results were converted into a single index value using UK as the reference country for all countries. Range -0.3 (worst possible state) to 1 (best possible state).
Time Frame Baseline, Day 5, Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (only evaluable patients with non-missing information included)
Arm/Group Title Serelaxin + Standard of Care Standard of Care (SOC)
Hide Arm/Group Description:
Serelaxin (30 µg/kg/day) as continuous 48 hour intravenous infusion plus standard of care.
All patients were required to receive standard of care background heart failure (HF) management during the study, according to local guidelines/international standards. This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.
Overall Number of Participants Analyzed 1545 793
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day 5 Number Analyzed 1545 participants 793 participants
0.28  (0.298) 0.27  (0.292)
Day 14 Number Analyzed 1486 participants 756 participants
0.32  (0.328) 0.31  (0.317)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Serelaxin + Standard of Care, Standard of Care (SOC)
Comments Day 5
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3115
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Serelaxin + Standard of Care, Standard of Care (SOC)
Comments Day 14
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1236
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Time Frame All Cause Mortality: 30 days (additional deaths are included which occurred after the clinical trial reporting period of 30 days for up to 8 months post randomization); Serious Adverse Events: 14 days; Other non-serious Adverse Events (AEs): 5 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Serelaxin + Standard of Care Standard of Care (SOC)
Hide Arm/Group Description Serelaxin (30 μg/kg/day) as continuous 48 hour intravenous infusion plus standard of care. All patients were required to receive standard of care background heart failure (HF) management during the study, according to local guidelines/international standards. This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.
All-Cause Mortality
Serelaxin + Standard of Care Standard of Care (SOC)
Affected / at Risk (%) Affected / at Risk (%)
Total   63/1729 (3.64%)   43/894 (4.81%) 
Show Serious Adverse Events Hide Serious Adverse Events
Serelaxin + Standard of Care Standard of Care (SOC)
Affected / at Risk (%) Affected / at Risk (%)
Total   214/1729 (12.38%)   107/894 (11.97%) 
Blood and lymphatic system disorders     
Anaemia  1  1/1729 (0.06%)  1/894 (0.11%) 
Microcytic anaemia  1  1/1729 (0.06%)  0/894 (0.00%) 
Cardiac disorders     
Acute coronary syndrome  1  1/1729 (0.06%)  0/894 (0.00%) 
Acute left ventricular failure  1  1/1729 (0.06%)  0/894 (0.00%) 
Acute myocardial infarction  1  6/1729 (0.35%)  4/894 (0.45%) 
Angina pectoris  1  0/1729 (0.00%)  2/894 (0.22%) 
Angina unstable  1  1/1729 (0.06%)  4/894 (0.45%) 
Aortic valve incompetence  1  0/1729 (0.00%)  1/894 (0.11%) 
Aortic valve stenosis  1  1/1729 (0.06%)  3/894 (0.34%) 
Atrial fibrillation  1  6/1729 (0.35%)  1/894 (0.11%) 
Atrioventricular block complete  1  3/1729 (0.17%)  0/894 (0.00%) 
Atrioventricular block second degree  1  0/1729 (0.00%)  1/894 (0.11%) 
Bradyarrhythmia  1  2/1729 (0.12%)  0/894 (0.00%) 
Bradycardia  1  7/1729 (0.40%)  2/894 (0.22%) 
Bundle branch block left  1  0/1729 (0.00%)  1/894 (0.11%) 
Cardiac arrest  1  6/1729 (0.35%)  2/894 (0.22%) 
Cardiac failure  1  38/1729 (2.20%)  26/894 (2.91%) 
Cardiac failure acute  1  6/1729 (0.35%)  2/894 (0.22%) 
Cardiac failure chronic  1  2/1729 (0.12%)  1/894 (0.11%) 
Cardiac failure congestive  1  2/1729 (0.12%)  1/894 (0.11%) 
Cardiac hypertrophy  1  0/1729 (0.00%)  1/894 (0.11%) 
Cardiac ventricular thrombosis  1  0/1729 (0.00%)  1/894 (0.11%) 
Cardio-respiratory arrest  1  1/1729 (0.06%)  0/894 (0.00%) 
Cardiogenic shock  1  3/1729 (0.17%)  2/894 (0.22%) 
Cardiopulmonary failure  1  1/1729 (0.06%)  0/894 (0.00%) 
Cardiorenal syndrome  1  1/1729 (0.06%)  0/894 (0.00%) 
Cardiovascular insufficiency  1  1/1729 (0.06%)  0/894 (0.00%) 
Congestive cardiomyopathy  1  1/1729 (0.06%)  0/894 (0.00%) 
Coronary artery disease  1  7/1729 (0.40%)  4/894 (0.45%) 
Coronary artery stenosis  1  0/1729 (0.00%)  1/894 (0.11%) 
Diastolic dysfunction  1  1/1729 (0.06%)  0/894 (0.00%) 
Left ventricular failure  1  1/1729 (0.06%)  1/894 (0.11%) 
Mitral valve incompetence  1  5/1729 (0.29%)  1/894 (0.11%) 
Myocardial infarction  1  2/1729 (0.12%)  3/894 (0.34%) 
Myocardial ischaemia  1  2/1729 (0.12%)  0/894 (0.00%) 
Myocarditis  1  1/1729 (0.06%)  0/894 (0.00%) 
Right ventricular failure  1  0/1729 (0.00%)  1/894 (0.11%) 
Sinus arrest  1  1/1729 (0.06%)  0/894 (0.00%) 
Stress cardiomyopathy  1  1/1729 (0.06%)  0/894 (0.00%) 
Tachycardia  1  0/1729 (0.00%)  1/894 (0.11%) 
Ventricular fibrillation  1  5/1729 (0.29%)  1/894 (0.11%) 
Ventricular tachycardia  1  5/1729 (0.29%)  2/894 (0.22%) 
Endocrine disorders     
Hypothyroidism  1  1/1729 (0.06%)  0/894 (0.00%) 
Eye disorders     
Glaucoma  1  1/1729 (0.06%)  0/894 (0.00%) 
Gastrointestinal disorders     
Abdominal pain lower  1  1/1729 (0.06%)  0/894 (0.00%) 
Abdominal strangulated hernia  1  1/1729 (0.06%)  0/894 (0.00%) 
Constipation  1  0/1729 (0.00%)  1/894 (0.11%) 
Duodenal ulcer haemorrhage  1  1/1729 (0.06%)  0/894 (0.00%) 
Dysphagia  1  1/1729 (0.06%)  0/894 (0.00%) 
Gastrointestinal haemorrhage  1  2/1729 (0.12%)  0/894 (0.00%) 
Intestinal ischaemia  1  3/1729 (0.17%)  0/894 (0.00%) 
Melaena  1  1/1729 (0.06%)  0/894 (0.00%) 
Nausea  1  1/1729 (0.06%)  0/894 (0.00%) 
Vomiting  1  2/1729 (0.12%)  0/894 (0.00%) 
General disorders     
Death  1  0/1729 (0.00%)  1/894 (0.11%) 
Fatigue  1  1/1729 (0.06%)  0/894 (0.00%) 
Hyperthermia  1  1/1729 (0.06%)  0/894 (0.00%) 
Non-cardiac chest pain  1  1/1729 (0.06%)  0/894 (0.00%) 
Organ failure  1  0/1729 (0.00%)  1/894 (0.11%) 
Pyrexia  1  4/1729 (0.23%)  2/894 (0.22%) 
Sudden cardiac death  1  1/1729 (0.06%)  0/894 (0.00%) 
Sudden death  1  1/1729 (0.06%)  0/894 (0.00%) 
Systemic inflammatory response syndrome  1  1/1729 (0.06%)  0/894 (0.00%) 
Hepatobiliary disorders     
Cholecystitis  1  1/1729 (0.06%)  0/894 (0.00%) 
Cholelithiasis  1  0/1729 (0.00%)  1/894 (0.11%) 
Hepatitis toxic  1  2/1729 (0.12%)  0/894 (0.00%) 
Infections and infestations     
Bacteraemia  1  1/1729 (0.06%)  0/894 (0.00%) 
Bronchitis  1  3/1729 (0.17%)  1/894 (0.11%) 
Diverticulitis  1  1/1729 (0.06%)  0/894 (0.00%) 
Escherichia urinary tract infection  1  1/1729 (0.06%)  0/894 (0.00%) 
Infection  1  1/1729 (0.06%)  0/894 (0.00%) 
Lower respiratory tract infection  1  1/1729 (0.06%)  0/894 (0.00%) 
Nosocomial infection  1  1/1729 (0.06%)  0/894 (0.00%) 
Oropharyngitis fungal  1  1/1729 (0.06%)  0/894 (0.00%) 
Parainfluenzae virus infection  1  1/1729 (0.06%)  0/894 (0.00%) 
Pneumonia  1  11/1729 (0.64%)  6/894 (0.67%) 
Pneumonia influenzal  1  1/1729 (0.06%)  0/894 (0.00%) 
Pneumonia klebsiella  1  1/1729 (0.06%)  0/894 (0.00%) 
Pneumonia pneumococcal  1  0/1729 (0.00%)  1/894 (0.11%) 
Respiratory tract infection  1  1/1729 (0.06%)  0/894 (0.00%) 
Sepsis  1  2/1729 (0.12%)  2/894 (0.22%) 
Skin bacterial infection  1  1/1729 (0.06%)  0/894 (0.00%) 
Staphylococcal bacteraemia  1  1/1729 (0.06%)  0/894 (0.00%) 
Staphylococcal infection  1  0/1729 (0.00%)  1/894 (0.11%) 
Streptococcal infection  1  1/1729 (0.06%)  0/894 (0.00%) 
Tracheobronchitis  1  2/1729 (0.12%)  0/894 (0.00%) 
Urinary tract infection  1  3/1729 (0.17%)  4/894 (0.45%) 
Urosepsis  1  2/1729 (0.12%)  0/894 (0.00%) 
Injury, poisoning and procedural complications     
Abdominal injury  1  1/1729 (0.06%)  0/894 (0.00%) 
Ankle fracture  1  0/1729 (0.00%)  1/894 (0.11%) 
Craniocerebral injury  1  1/1729 (0.06%)  0/894 (0.00%) 
Fall  1  0/1729 (0.00%)  2/894 (0.22%) 
Femoral neck fracture  1  1/1729 (0.06%)  0/894 (0.00%) 
Haematuria traumatic  1  1/1729 (0.06%)  0/894 (0.00%) 
Head injury  1  1/1729 (0.06%)  0/894 (0.00%) 
Hip fracture  1  0/1729 (0.00%)  1/894 (0.11%) 
Lumbar vertebral fracture  1  2/1729 (0.12%)  0/894 (0.00%) 
Post procedural haemorrhage  1  1/1729 (0.06%)  0/894 (0.00%) 
Procedural pneumothorax  1  1/1729 (0.06%)  0/894 (0.00%) 
Subdural haemorrhage  1  1/1729 (0.06%)  0/894 (0.00%) 
Toxicity to various agents  1  1/1729 (0.06%)  0/894 (0.00%) 
Traumatic haematoma  1  0/1729 (0.00%)  1/894 (0.11%) 
Vascular pseudoaneurysm  1  2/1729 (0.12%)  0/894 (0.00%) 
Investigations     
Blood bilirubin increased  1  1/1729 (0.06%)  0/894 (0.00%) 
Blood creatinine increased  1  1/1729 (0.06%)  1/894 (0.11%) 
Electrocardiogram T wave inversion  1  1/1729 (0.06%)  0/894 (0.00%) 
Haemoglobin decreased  1  1/1729 (0.06%)  0/894 (0.00%) 
Heart rate decreased  1  0/1729 (0.00%)  1/894 (0.11%) 
International normalised ratio decreased  1  0/1729 (0.00%)  1/894 (0.11%) 
International normalised ratio increased  1  0/1729 (0.00%)  1/894 (0.11%) 
Liver function test increased  1  1/1729 (0.06%)  0/894 (0.00%) 
Oxygen saturation decreased  1  0/1729 (0.00%)  1/894 (0.11%) 
Metabolism and nutrition disorders     
Dehydration  1  2/1729 (0.12%)  0/894 (0.00%) 
Diabetic ketoacidosis  1  1/1729 (0.06%)  0/894 (0.00%) 
Gout  1  1/1729 (0.06%)  0/894 (0.00%) 
Hyperammonaemia  1  1/1729 (0.06%)  0/894 (0.00%) 
Hyperkalaemia  1  1/1729 (0.06%)  0/894 (0.00%) 
Hypoglycaemia  1  1/1729 (0.06%)  2/894 (0.22%) 
Hypokalaemia  1  0/1729 (0.00%)  2/894 (0.22%) 
Type 2 diabetes mellitus  1  0/1729 (0.00%)  1/894 (0.11%) 
Musculoskeletal and connective tissue disorders     
Chest wall haematoma  1  0/1729 (0.00%)  1/894 (0.11%) 
Joint swelling  1  1/1729 (0.06%)  0/894 (0.00%) 
Muscle haemorrhage  1  0/1729 (0.00%)  1/894 (0.11%) 
Rhabdomyolysis  1  1/1729 (0.06%)  0/894 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder transitional cell carcinoma  1  0/1729 (0.00%)  1/894 (0.11%) 
Colon cancer  1  1/1729 (0.06%)  0/894 (0.00%) 
Gastric cancer  1  0/1729 (0.00%)  1/894 (0.11%) 
Leiomyoma  1  1/1729 (0.06%)  0/894 (0.00%) 
Lung neoplasm malignant  1  1/1729 (0.06%)  0/894 (0.00%) 
Plasma cell myeloma  1  1/1729 (0.06%)  0/894 (0.00%) 
Prostate cancer metastatic  1  0/1729 (0.00%)  1/894 (0.11%) 
Nervous system disorders     
Brain oedema  1  1/1729 (0.06%)  0/894 (0.00%) 
Carotid artery stenosis  1  0/1729 (0.00%)  1/894 (0.11%) 
Cerebrovascular accident  1  1/1729 (0.06%)  1/894 (0.11%) 
Depressed level of consciousness  1  1/1729 (0.06%)  0/894 (0.00%) 
Epilepsy  1  2/1729 (0.12%)  0/894 (0.00%) 
Hypercapnic coma  1  0/1729 (0.00%)  1/894 (0.11%) 
Ischaemic stroke  1  3/1729 (0.17%)  4/894 (0.45%) 
Loss of consciousness  1  0/1729 (0.00%)  1/894 (0.11%) 
Seizure  1  1/1729 (0.06%)  0/894 (0.00%) 
Status epilepticus  1  1/1729 (0.06%)  0/894 (0.00%) 
Psychiatric disorders     
Agitation  1  1/1729 (0.06%)  0/894 (0.00%) 
Confusional state  1  2/1729 (0.12%)  0/894 (0.00%) 
Delirium  1  2/1729 (0.12%)  0/894 (0.00%) 
Renal and urinary disorders     
Acute kidney injury  1  9/1729 (0.52%)  4/894 (0.45%) 
Acute prerenal failure  1  0/1729 (0.00%)  1/894 (0.11%) 
Anuria  1  0/1729 (0.00%)  1/894 (0.11%) 
Chronic kidney disease  1  2/1729 (0.12%)  0/894 (0.00%) 
Haematuria  1  1/1729 (0.06%)  0/894 (0.00%) 
Nephropathy  1  1/1729 (0.06%)  0/894 (0.00%) 
Nephropathy toxic  1  1/1729 (0.06%)  0/894 (0.00%) 
Nephrotic syndrome  1  1/1729 (0.06%)  1/894 (0.11%) 
Prerenal failure  1  1/1729 (0.06%)  0/894 (0.00%) 
Renal failure  1  6/1729 (0.35%)  3/894 (0.34%) 
Renal impairment  1  4/1729 (0.23%)  5/894 (0.56%) 
Renal tubular necrosis  1  1/1729 (0.06%)  1/894 (0.11%) 
Urinary retention  1  1/1729 (0.06%)  0/894 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute pulmonary oedema  1  6/1729 (0.35%)  1/894 (0.11%) 
Acute respiratory distress syndrome  1  0/1729 (0.00%)  1/894 (0.11%) 
Acute respiratory failure  1  1/1729 (0.06%)  1/894 (0.11%) 
Chronic obstructive pulmonary disease  1  1/1729 (0.06%)  1/894 (0.11%) 
Dyspnoea  1  2/1729 (0.12%)  3/894 (0.34%) 
Haemothorax  1  1/1729 (0.06%)  1/894 (0.11%) 
Hypercapnia  1  1/1729 (0.06%)  2/894 (0.22%) 
Pleural effusion  1  1/1729 (0.06%)  0/894 (0.00%) 
Pulmonary hypertension  1  1/1729 (0.06%)  0/894 (0.00%) 
Pulmonary mass  1  1/1729 (0.06%)  0/894 (0.00%) 
Pulmonary oedema  1  3/1729 (0.17%)  2/894 (0.22%) 
Respiratory disorder  1  1/1729 (0.06%)  0/894 (0.00%) 
Respiratory distress  1  0/1729 (0.00%)  1/894 (0.11%) 
Respiratory failure  1  6/1729 (0.35%)  0/894 (0.00%) 
Skin and subcutaneous tissue disorders     
Dermatitis exfoliative  1  0/1729 (0.00%)  1/894 (0.11%) 
Surgical and medical procedures     
Left atrial appendage occlusion  1  1/1729 (0.06%)  0/894 (0.00%) 
Vascular disorders     
Aortic stenosis  1  1/1729 (0.06%)  0/894 (0.00%) 
Arterial disorder  1  1/1729 (0.06%)  0/894 (0.00%) 
Arterial stenosis  1  1/1729 (0.06%)  0/894 (0.00%) 
Arteriosclerosis  1  1/1729 (0.06%)  0/894 (0.00%) 
Arteriovenous fistula  1  0/1729 (0.00%)  1/894 (0.11%) 
Circulatory collapse  1  0/1729 (0.00%)  1/894 (0.11%) 
Femoral artery aneurysm  1  0/1729 (0.00%)  1/894 (0.11%) 
Haematoma  1  1/1729 (0.06%)  0/894 (0.00%) 
Hypertension  1  2/1729 (0.12%)  1/894 (0.11%) 
Hypertensive crisis  1  1/1729 (0.06%)  0/894 (0.00%) 
Hypotension  1  7/1729 (0.40%)  2/894 (0.22%) 
Peripheral artery thrombosis  1  2/1729 (0.12%)  0/894 (0.00%) 
Peripheral ischaemia  1  0/1729 (0.00%)  1/894 (0.11%) 
Shock haemorrhagic  1  0/1729 (0.00%)  1/894 (0.11%) 
1
Term from vocabulary, MedDRA (20.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1.5%
Serelaxin + Standard of Care Standard of Care (SOC)
Affected / at Risk (%) Affected / at Risk (%)
Total   637/1729 (36.84%)   324/894 (36.24%) 
Blood and lymphatic system disorders     
Anaemia  1  49/1729 (2.83%)  9/894 (1.01%) 
Cardiac disorders     
Atrial fibrillation  1  34/1729 (1.97%)  23/894 (2.57%) 
Cardiac failure  1  81/1729 (4.68%)  56/894 (6.26%) 
Mitral valve incompetence  1  28/1729 (1.62%)  12/894 (1.34%) 
Gastrointestinal disorders     
Constipation  1  74/1729 (4.28%)  32/894 (3.58%) 
Diarrhoea  1  29/1729 (1.68%)  21/894 (2.35%) 
Nausea  1  40/1729 (2.31%)  17/894 (1.90%) 
General disorders     
Pyrexia  1  24/1729 (1.39%)  21/894 (2.35%) 
Infections and infestations     
Bronchitis  1  24/1729 (1.39%)  14/894 (1.57%) 
Urinary tract infection  1  56/1729 (3.24%)  26/894 (2.91%) 
Investigations     
Blood pressure systolic decreased  1  49/1729 (2.83%)  2/894 (0.22%) 
Metabolism and nutrition disorders     
Hyperuricaemia  1  47/1729 (2.72%)  35/894 (3.91%) 
Hypokalaemia  1  119/1729 (6.88%)  73/894 (8.17%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  28/1729 (1.62%)  11/894 (1.23%) 
Muscle spasms  1  33/1729 (1.91%)  8/894 (0.89%) 
Nervous system disorders     
Headache  1  45/1729 (2.60%)  18/894 (2.01%) 
Psychiatric disorders     
Anxiety  1  27/1729 (1.56%)  16/894 (1.79%) 
Insomnia  1  58/1729 (3.35%)  21/894 (2.35%) 
Renal and urinary disorders     
Renal failure  1  18/1729 (1.04%)  18/894 (2.01%) 
Renal impairment  1  30/1729 (1.74%)  18/894 (2.01%) 
Vascular disorders     
Hypotension  1  48/1729 (2.78%)  18/894 (2.01%) 
1
Term from vocabulary, MedDRA (20.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
EMail: novartis.email@novartis.com
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT02064868     History of Changes
Other Study ID Numbers: CRLX030A3301
2013-002513-35 ( EudraCT Number )
First Submitted: February 14, 2014
First Posted: February 17, 2014
Results First Submitted: April 24, 2018
Results First Posted: March 22, 2019
Last Update Posted: March 22, 2019