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Efficacy and Safety of Aliskiren and Aliskiren/Enalapril Combination on Morbidity-mortality in Patients With Chronic Heart Failure (ATMOSPHERE)

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ClinicalTrials.gov Identifier: NCT00853658
Recruitment Status : Completed
First Posted : March 2, 2009
Results First Posted : November 25, 2016
Last Update Posted : November 25, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE February 26, 2009
First Posted Date  ICMJE March 2, 2009
Results First Submitted Date  ICMJE October 3, 2016
Results First Posted Date  ICMJE November 25, 2016
Last Update Posted Date November 25, 2016
Study Start Date  ICMJE March 2009
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 3, 2016)
Number of Participants That Had First Occurrence of the Composite Endpoint, Which is Defined as Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization [ Time Frame: up to End of Study (78 months) ]
Number of participants that had first occurrence of the composite endpoint, which is defined as either CV death or HF hospitalization due to HF.
Original Primary Outcome Measures  ICMJE
 (submitted: February 27, 2009)
Delaying time to first occurrence of either cardiovascular death or heart failure hospitalization in patients with chronic heart failure [ Time Frame: 4 years ]
Change History Complete list of historical versions of study NCT00853658 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2016)
  • Change From Baseline to Month 12 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score [ Time Frame: Baseline, Month 12 ]
    Change from baseline to Month 12 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score. KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. KCCQ clinical summary score is a composite assessment of physical limitations and total symptom scores. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
  • All Cause Death [ Time Frame: up to end of study (78 months) ]
    Number of patients - All-cause death. All-cause death is common in Heart Failure HF patients this measures how many patients had this event.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2009)
  • Reduction in the BNP level from baseline to predefined timepoint [ Time Frame: 1 year ]
  • Improvement in the clinical summary score (assessed by KCCQ) from baseline to predefined timepoint. [ Time Frame: 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Aliskiren and Aliskiren/Enalapril Combination on Morbidity-mortality in Patients With Chronic Heart Failure
Official Title  ICMJE A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of Both Aliskiren Monotherapy and Aliskiren/Enalapril Combination Therapy Compared to Enalapril Monotherapy, on Morbidity and Mortality in Patients With Chronic Heart Failure (NYHA Class II - IV). The Study is Also Known as Aliskiren Trial of Minimizing OutcomeS in Patients With HEart Failure (ATMOSPHERE).
Brief Summary The study will evaluate the efficacy and safety of both aliskiren monotherapy and aliskiren/enalapril combination therapy as compared to enalapril monotherapy, on morbidity and mortality in patients with chronic heart failure (NYHA Class II - IV.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Heart Failure
Intervention  ICMJE
  • Drug: Enalapril
    Enalapril 10 mg film-coated tablet and administered orally.
  • Drug: Aliskiren
    Aliskiren 150 mg titrated to 300 mg film-coated tablet and administered orally.
    Other Name: SPP100
Study Arms  ICMJE
  • Experimental: Combination Aliskiren / Enalapril
    Aliskiren / Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg film-coated tablets and administered orally.
    Interventions:
    • Drug: Enalapril
    • Drug: Aliskiren
  • Experimental: Aliskiren
    Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally.
    Intervention: Drug: Aliskiren
  • Active Comparator: Enalapril
    Enalapril monotherapy -10 mg film-coated tablet and administered orally.
    Intervention: Drug: Enalapril
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 3, 2016)
7064
Original Estimated Enrollment  ICMJE
 (submitted: February 27, 2009)
7041
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

Patients eligible for inclusion in this study had to fulfill all of the following criteria:

  1. Patients ≥ 18 years of age, male or female.
  2. Patients with a diagnosis of chronic heart failure (NYHA

    Class II - IV):

    1. LVEF ≤ 35% at Visit 1 (local measurement, within the past 6 months assessed by echocardiography, multiple uptake gated acquisition scan (MUGA), computerized tomography(CT) scan, magnetic resonance imaging (MRI) or ventricular angiography)
    2. Elevated BNP or NT-proBNP at Visit 1:

    BNP ≥ 150 pg/mL (or BNP ≥ 100 pg/mL and unplanned hospitalization for HF within the last 12 months prior to Visit 1) (according to local measurement). OR NT-proBNP ≥ 600 pg/mL (or NT-proBNP ≥ 400 pg/mL and unplanned hospitalization for HF within the last 12 months prior to Visit 1) (according to local measurement).

  3. Patients had to be treated with an ACEI at a stable dose enalapril 10 mg daily at least or any other ACEI, e.g. ramipril, quinapril, lisinopril, fosinopril, perindopril, trandolapril; based on equivalent doses, for at least 4 weeks prior to Visit 1
  4. Patients had to be treated with a beta-blocker, unless contraindicated or not tolerated, at a stable dose for at least 4 weeks prior to visit 1 (for patients not on target dose, according to local guidelines, or in absence of that medication, the reason should be documented).
  5. Written informed consent to participate in the study and ability to comply with all requirements.

Exclusion Criteria

Patients with any of the following were to be excluded from participation in the study:

  1. History of hypersensitivity to any of the study drugs including history or allergy to ACEIs as well as known or suspected contraindications to the study drugs or previous history of intolerance to high doses of ACEIs during up- titration process.
  2. Patients treated concomitantly with both an ARB and an aldosterone antagonist in addition to study drug at Visit 1.
  3. Current acute decompensated HF (defined as an acute exacerbation of a chronic heart failure status manifested by typical signs and symptoms of HF like dyspnea, fatigue etc., that may require IV therapy with diuretics, vasodilators and/or inotropic drugs).
  4. Symptomatic hypotension and/or less than 95 mmHg systolic blood pressure (SBP) at Visit 1 and/or less than 90 mmHg SBP at Visit 4.
  5. Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or major vascular surgery, percutaneous coronary intervention (PCI) or carotid angioplasty, within the past 3 months prior to Visit 1.
  6. Coronary or carotid artery disease likely to require surgical or percutaneous intervention within the 6 months after Visit 1.
  7. Right heart failure due to severe pulmonary disease.
  8. Patients with Diabetes Mellitus.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   China,   Colombia,   Costa Rica,   Czech Republic,   Denmark,   Dominican Republic,   Estonia,   Finland,   France,   Germany,   Greece,   India,   Ireland,   Italy,   Japan,   Korea, Republic of,   Latvia,   Lithuania,   Mexico,   Netherlands,   Norway,   Peru,   Poland,   Portugal,   Puerto Rico,   Romania,   Russian Federation,   Slovakia,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   Thailand,   Turkey,   United Kingdom,   United States,   Venezuela
Removed Location Countries Hungary,   Iceland
 
Administrative Information
NCT Number  ICMJE NCT00853658
Other Study ID Numbers  ICMJE CSPP100F2301
2008-004104-31 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP