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Trial record 92 of 163 for:    Idiopathic Dilated Cardiomyopathy

Harefield Recovery Protocol Study for Patients With Refractory Chronic Heart Failure (HARPS)

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ClinicalTrials.gov Identifier: NCT00585546
Recruitment Status : Terminated (No longer could obtain clenbuterol)
First Posted : January 3, 2008
Results First Posted : December 15, 2017
Last Update Posted : December 15, 2017
Sponsor:
Collaborators:
Georgetown University
Montefiore Medical Center
Northwestern University
Ohio State University
Texas Heart Institute
University of Minnesota
University of Pennsylvania
Thoratec Corporation
Information provided by (Responsible Party):
Francis D. Pagani, University of Michigan

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Heart Failure
Dilated Cardiomyopathy
Intervention Drug: clenbuterol
Enrollment 18
Recruitment Details  
Pre-assignment Details Of 19 consented, 1 was a screen fail and did not enter the study protocol.
Arm/Group Title LVAD and (Intended) Clenbuterol
Hide Arm/Group Description

Participants, all of whom received LVAD implantation, were to begin clenbuterol treatment 12 weeks after their implantation.

Clenbuterol 20 mcg tablets uptitrated from 20 mcg PO TID to a maximally tolerated dose not to exceed 700 mcg PO TID. Patients will then be switched to the equivalent dose of clenbuterol liquid 59 mcg/ml PO TID. Clenbuterol will be administered for a minimum of 3 months and a maximum of 12 months.

Period Title: LVAD Implantation Required for 4 Months
Started 18
Completed 13
Not Completed 5
Period Title: Clenbuterol Treatment - up to 12 Months
Started 13
Completed 9
Not Completed 4
Reason Not Completed
Death             1
Adverse Event             3
Arm/Group Title LVAD and Clenbuterol
Hide Arm/Group Description clenbuterol: Clenbuterol 20 mcg tablets uptitrated from 20 mcg PO TID to a maximally tolerated dose not to exceed 700 mcg PO TID. Patients will then be switched to the equivalent dose of clenbuterol liquid 59 mcg/ml PO TID. Clenbuterol will be administered for a minimum of 3 months and a maximum of 12 months.
Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 18 participants
57
(54 to 62)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
2
  11.1%
Male
16
  88.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants
18
1.Primary Outcome
Title Percent of Subjects Who Experience LVAD Removal and Subsequent Freedom From Mechanical Circulatory Support or Heart Transplantation for 1-year After Explantation
Hide Description [Not Specified]
Time Frame One year after LVAD explant or until transplant or death (if not explanted)
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title LVAD and Clenbuterol
Hide Arm/Group Description:
clenbuterol: Clenbuterol 20 mcg tablets uptitrated from 20 mcg PO TID to a maximally tolerated dose not to exceed 700 mcg PO TID. Patients will then be switched to the equivalent dose of clenbuterol liquid 59 mcg/ml PO TID. Clenbuterol will be administered for a minimum of 3 months and a maximum of 12 months.
Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: percentage of participants
5.6
2.Secondary Outcome
Title The Number of Evaluable Subjects Meeting Explant Criteria and Subsequently Explanted
Hide Description [Not Specified]
Time Frame Maximum 12 months after LVAD implantation
Hide Outcome Measure Data
Hide Analysis Population Description
Because only 13 began Clenbuterol, only 13 are "evaluable" for this purpose.
Arm/Group Title LVAD and Clenbuterol
Hide Arm/Group Description:
clenbuterol: Clenbuterol 20 mcg tablets uptitrated from 20 mcg PO TID to a maximally tolerated dose not to exceed 700 mcg PO TID. Patients will then be switched to the equivalent dose of clenbuterol liquid 59 mcg/ml PO TID. Clenbuterol will be administered for a minimum of 3 months and a maximum of 12 months.
Overall Number of Participants Analyzed 13
Measure Type: Count of Participants
Unit of Measure: Participants
1
   7.7%
3.Secondary Outcome
Title Number of Subjects Who Received Maximum Target Dose of Clenbuterol
Hide Description [Not Specified]
Time Frame Up to 16 months after LVAD implantation (12 months after beginning clenbuterol)
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title LVAD and Clenbuterol
Hide Arm/Group Description:
clenbuterol: Clenbuterol 20 mcg tablets uptitrated from 20 mcg PO TID to a maximally tolerated dose not to exceed 700 mcg PO TID. Patients will then be switched to the equivalent dose of clenbuterol liquid 59 mcg/ml PO TID. Clenbuterol will be administered for a minimum of 3 months and a maximum of 12 months.
Overall Number of Participants Analyzed 13
Measure Type: Count of Participants
Unit of Measure: Participants
13
 100.0%
4.Secondary Outcome
Title Time to Device Explant for Subjects Meeting Explant Criteria Defined in the Protocol
Hide Description Time from LVAD placement to explant for the single participant who achieved explant
Time Frame Time to explant (but not to be followed for more than 16 months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LVAD and Clenbuterol
Hide Arm/Group Description:
clenbuterol: Clenbuterol 20 mcg tablets uptitrated from 20 mcg PO TID to a maximally tolerated dose not to exceed 700 mcg PO TID. Patients will then be switched to the equivalent dose of clenbuterol liquid 59 mcg/ml PO TID. Clenbuterol will be administered for a minimum of 3 months and a maximum of 12 months.
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: weeks
28
5.Secondary Outcome
Title Absolute Change in Left Ventricular Ejection Fraction From Explant to 18 Months Following Device Explant
Hide Description [Not Specified]
Time Frame 18 months after explantation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LVAD and Clenbuterol
Hide Arm/Group Description:
clenbuterol: Clenbuterol 20 mcg tablets uptitrated from 20 mcg PO TID to a maximally tolerated dose not to exceed 700 mcg PO TID. Patients will then be switched to the equivalent dose of clenbuterol liquid 59 mcg/ml PO TID. Clenbuterol will be administered for a minimum of 3 months and a maximum of 12 months.
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: absolute change in ejection fraction
-.09
6.Secondary Outcome
Title Absolute Percent Change in Serum Creatinine and Aspartate Transaminase (AST) From Baseline to Week 8 Post Implant
Hide Description [Not Specified]
Time Frame Up to 8 weeks after LVAD implantation
Hide Outcome Measure Data
Hide Analysis Population Description
Because data only is available for 15 participants for 8 week post implant AST value, it has a different participants analyzed value
Arm/Group Title LVAD and Clenbuterol
Hide Arm/Group Description:
clenbuterol: Clenbuterol 20 mcg tablets uptitrated from 20 mcg PO TID to a maximally tolerated dose not to exceed 700 mcg PO TID. Patients will then be switched to the equivalent dose of clenbuterol liquid 59 mcg/ml PO TID. Clenbuterol will be administered for a minimum of 3 months and a maximum of 12 months.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: percent change
Creatinine Number Analyzed 18 participants
17.2  (15.2)
aspartate transaminase (AST) Number Analyzed 15 participants
25  (19.7)
7.Secondary Outcome
Title Mean Change in EuroQoL Visual Analog Scale (EQ5D-VAS) From Baseline to 6 Months and 1 Year Following Device Implant
Hide Description Scale 0 - 100 where 0 is worst possible health state and 100 is perfect health.
Time Frame 1 year following LVAD implantation
Hide Outcome Measure Data
Hide Analysis Population Description
While baseline data was available for 13 participants at baseline, (start of clenbuterol), different numbers of participants provided evaluable data At six months post implant and 12 months, so the mean changes are based on the actual population that provided both data points as listed below
Arm/Group Title LVAD and Clenbuterol
Hide Arm/Group Description:
clenbuterol: Clenbuterol 20 mcg tablets uptitrated from 20 mcg PO TID to a maximally tolerated dose not to exceed 700 mcg PO TID. Patients will then be switched to the equivalent dose of clenbuterol liquid 59 mcg/ml PO TID. Clenbuterol will be administered for a minimum of 3 months and a maximum of 12 months.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
6 months post implant Number Analyzed 7 participants
46  (35)
12 months post implant Number Analyzed 12 participants
51  (30)
8.Secondary Outcome
Title Mean Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) From Baseline to 6 Months
Hide Description Scale 0 - 105 (0- 5 on 21 items) where 0 means heart failure has not limited daily life at all and high scores mean that daily functions are greatly limited.
Time Frame 6 months following LVAD implantation
Hide Outcome Measure Data
Hide Analysis Population Description
Only 11 participants provided usable data at the six month time point.
Arm/Group Title LVAD and Clenbuterol
Hide Arm/Group Description:
clenbuterol: Clenbuterol 20 mcg tablets uptitrated from 20 mcg PO TID to a maximally tolerated dose not to exceed 700 mcg PO TID. Patients will then be switched to the equivalent dose of clenbuterol liquid 59 mcg/ml PO TID. Clenbuterol will be administered for a minimum of 3 months and a maximum of 12 months.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
28.3  (19.7)
9.Secondary Outcome
Title Mean Change in Left Ventricular Ejection Fraction From Device Implant to Completion of Clenbuterol Therapy
Hide Description [Not Specified]
Time Frame up to 16 months, variable based on length of time receiveing clenbuterol
Hide Outcome Measure Data
Hide Analysis Population Description
data is available for 9 evaluable subjects at end of clenbuterol
Arm/Group Title LVAD and Clenbuterol
Hide Arm/Group Description:
clenbuterol: Clenbuterol 20 mcg tablets uptitrated from 20 mcg PO TID to a maximally tolerated dose not to exceed 700 mcg PO TID. Patients will then be switched to the equivalent dose of clenbuterol liquid 59 mcg/ml PO TID. Clenbuterol will be administered for a minimum of 3 months and a maximum of 12 months.
Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: ejection fraction
0.16  (.10)
10.Secondary Outcome
Title Absolute Percent Change in Serum Creatinine and Aspartate Transaminase (AST) From Baseline to Week 8 Post Clenbuterol
Hide Description [Not Specified]
Time Frame baseline to week 8 post clenbuterol
Hide Outcome Measure Data
Hide Analysis Population Description
baseline data is based on 19 participants, but different subsequent data collections had different numbers of evaluable subjects listed below
Arm/Group Title LVAD and Clenbuterol
Hide Arm/Group Description:
clenbuterol: Clenbuterol 20 mcg tablets uptitrated from 20 mcg PO TID to a maximally tolerated dose not to exceed 700 mcg PO TID. Patients will then be switched to the equivalent dose of clenbuterol liquid 59 mcg/ml PO TID. Clenbuterol will be administered for a minimum of 3 months and a maximum of 12 months.
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: percent change
creatinine from baseline to week 8 of clenbuterol Number Analyzed 10 participants
-15.8  (13.3)
AST from baseline to week 8 on clenbuterol Number Analyzed 9 participants
15.6  (14.3)
11.Secondary Outcome
Title Mean Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) From Baseline to 1 Year Following Device Implant
Hide Description Scale 0 - 105 (0- 5 on 21 items) where 0 means heart failure has not limited daily life at all and high scores mean that daily functions are greatly limited.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Data is not available for Minnesota Living with Heart Failure Questionnaire at the 12 month time point.
Arm/Group Title LVAD and Clenbuterol
Hide Arm/Group Description:
clenbuterol: Clenbuterol 20 mcg tablets uptitrated from 20 mcg PO TID to a maximally tolerated dose not to exceed 700 mcg PO TID. Patients will then be switched to the equivalent dose of clenbuterol liquid 59 mcg/ml PO TID. Clenbuterol will be administered for a minimum of 3 months and a maximum of 12 months.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse event data was collected for approximately 24 months or up to transplant, death, or explant
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LVAD and Clenbuterol
Hide Arm/Group Description clenbuterol: Clenbuterol 20 mcg tablets uptitrated from 20 mcg PO TID to a maximally tolerated dose not to exceed 700 mcg PO TID. Patients will then be switched to the equivalent dose of clenbuterol liquid 59 mcg/ml PO TID. Clenbuterol will be administered for a minimum of 3 months and a maximum of 12 months.
All-Cause Mortality
LVAD and Clenbuterol
Affected / at Risk (%)
Total   1/18 (5.56%) 
Show Serious Adverse Events Hide Serious Adverse Events
LVAD and Clenbuterol
Affected / at Risk (%)
Total   13/18 (72.22%) 
Blood and lymphatic system disorders   
Anemia, Pancytopenia   1/18 (5.56%) 
Cardiac disorders   
Cardiac arrhythmia   2/18 (11.11%) 
Cardiopulmonary Arrest   1/18 (5.56%) 
History Afib/Flutter since XVE Implant   1/18 (5.56%) 
Left Atrial Thrombus   1/18 (5.56%) 
Pericardial fluid collection   1/18 (5.56%) 
Heart Failure   1/18 (5.56%) 
Gastrointestinal disorders   
Abdominal Perforation Requiring Re-Operation   1/18 (5.56%) 
Bleeding   4/18 (22.22%) 
Nausea and Vomiting   1/18 (5.56%) 
Infections and infestations   
AV Endocarditis   1/18 (5.56%) 
Fever   1/18 (5.56%) 
Infection   3/18 (16.67%) 
Intermittent Fever, Pain, Leukocytosis   1/18 (5.56%) 
Viral Syndrome   1/18 (5.56%) 
Injury, poisoning and procedural complications   
Left Sided Pain Radiating to Axilla   1/18 (5.56%) 
Left sided pneumothorax - Left Pleural CT inserted   1/18 (5.56%) 
Retropericardial Hematoma   1/18 (5.56%) 
Nervous system disorders   
Neurological event   3/18 (16.67%) 
Product Issues   
Device malfunction   2/18 (11.11%) 
Renal and urinary disorders   
Dehydration   1/18 (5.56%) 
Renal dysfunction   1/18 (5.56%) 
Respiratory, thoracic and mediastinal disorders   
Hemoptysis   1/18 (5.56%) 
Left Pleural Effusion   1/18 (5.56%) 
Respiratory failure   1/18 (5.56%) 
Shortness of Breath   1/18 (5.56%) 
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 0%
LVAD and Clenbuterol
Affected / at Risk (%)
Total   11/18 (61.11%) 
Cardiac disorders   
Cardiac arrhythmia   1/18 (5.56%) 
Chest Pain   1/18 (5.56%) 
Hypertension   2/18 (11.11%) 
Implantable Cardioverter Defibrillator (ICD) Discharge   1/18 (5.56%) 
Sinus Tachycardia Leading to ICD Shocks   1/18 (5.56%) 
Hypotension   1/18 (5.56%) 
Gastrointestinal disorders   
Abdominal Pain   1/18 (5.56%) 
Bleeding   1/18 (5.56%) 
Vomiting   1/18 (5.56%) 
Blood Bowel Movement   1/18 (5.56%) 
Infections and infestations   
Elevated White Blood Cell/Leukocytosis   1/18 (5.56%) 
Infection   4/18 (22.22%) 
Injury, poisoning and procedural complications   
Muscle Pain   1/18 (5.56%) 
Severe Muscle Spasms   1/18 (5.56%) 
Musculoskeletal and connective tissue disorders   
Myalgia   1/18 (5.56%) 
Nervous system disorders   
Neurological   2/18 (11.11%) 
Psychiatric disorders   
Psychiatric episode   1/18 (5.56%) 
Renal and urinary disorders   
Hyperkalemia   1/18 (5.56%) 
Indicates events were collected by systematic assessment
Because a new standard of care was developed during the start of the trial, the trial was stopped for futility in enrollment. The public should exercise great caution in drawing conclusions from such a small sample size.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Francis Pagani
Organization: University of Michigan
Phone: 734 647-2894
EMail: fpagani@med.umich.edu
Layout table for additonal information
Responsible Party: Francis D. Pagani, University of Michigan
ClinicalTrials.gov Identifier: NCT00585546     History of Changes
Obsolete Identifiers: NCT00701116
Other Study ID Numbers: HARPS
First Submitted: December 26, 2007
First Posted: January 3, 2008
Results First Submitted: March 25, 2017
Results First Posted: December 15, 2017
Last Update Posted: December 15, 2017