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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 - Clinical and Translational Science Institute
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 19 consented, 1 was a screen fail and did not enter the study protocol.

Reporting Groups
  Description
LVAD and (Intended) Clenbuterol

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.


Participant Flow for 2 periods

Period 1:   LVAD Implantation Required for 4 Months
    LVAD and (Intended) Clenbuterol
STARTED   18 
COMPLETED   13 
NOT COMPLETED   5 

Period 2:   Clenbuterol Treatment - up to 12 Months
    LVAD and (Intended) Clenbuterol
STARTED   13 
COMPLETED   9 
NOT COMPLETED   4 
Death                1 
Adverse Event                3 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
LVAD and Clenbuterol 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.

Baseline Measures
   LVAD and Clenbuterol 
Overall Participants Analyzed 
[Units: Participants]
 18 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 57 
 (54 to 62) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      2  11.1% 
Male      16  88.9% 
Region of Enrollment 
[Units: Participants]
 
United States   18 


  Outcome Measures

1.  Primary:   Percent of Subjects Who Experience LVAD Removal and Subsequent Freedom From Mechanical Circulatory Support or Heart Transplantation for 1-year After Explantation   [ Time Frame: One year after LVAD explant or until transplant or death (if not explanted) ]

2.  Secondary:   The Number of Evaluable Subjects Meeting Explant Criteria and Subsequently Explanted   [ Time Frame: Maximum 12 months after LVAD implantation ]

3.  Secondary:   Number of Subjects Who Received Maximum Target Dose of Clenbuterol   [ Time Frame: Up to 16 months after LVAD implantation (12 months after beginning clenbuterol) ]

4.  Secondary:   Time to Device Explant for Subjects Meeting Explant Criteria Defined in the Protocol   [ Time Frame: Time to explant (but not to be followed for more than 16 months) ]

5.  Secondary:   Absolute Change in Left Ventricular Ejection Fraction From Explant to 18 Months Following Device Explant   [ Time Frame: 18 months after explantation ]

6.  Secondary:   Absolute Percent Change in Serum Creatinine and Aspartate Transaminase (AST) From Baseline to Week 8 Post Implant   [ Time Frame: Up to 8 weeks after LVAD implantation ]

7.  Secondary:   Mean Change in EuroQoL Visual Analog Scale (EQ5D-VAS) From Baseline to 6 Months and 1 Year Following Device Implant   [ Time Frame: 1 year following LVAD implantation ]

8.  Secondary:   Mean Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) From Baseline to 6 Months   [ Time Frame: 6 months following LVAD implantation ]

9.  Secondary:   Mean Change in Left Ventricular Ejection Fraction From Device Implant to Completion of Clenbuterol Therapy   [ Time Frame: up to 16 months, variable based on length of time receiveing clenbuterol ]

10.  Secondary:   Absolute Percent Change in Serum Creatinine and Aspartate Transaminase (AST) From Baseline to Week 8 Post Clenbuterol   [ Time Frame: baseline to week 8 post clenbuterol ]

11.  Secondary:   Mean Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) From Baseline to 1 Year Following Device Implant   [ Time Frame: 1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Francis Pagani
Organization: University of Michigan
phone: 734 647-2894
e-mail: fpagani@med.umich.edu


Publications:

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