Harefield Recovery Protocol Study for Patients With Refractory Chronic Heart Failure

• Status: Terminated
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate whether patients with chronic heart failure not due to coronary artery disease who require use of a left ventricular assist device (LVAD) for refractory heart failure can recover sufficient heart function to allow the pump to be explanted. The study aims to avoid the need for transplantation in these patients by using standard heart failure medications to reduce the size of the left ventricle and then using the investigational drug, clenbuterol, to further improve left ventricular function.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Francis D. Pagani
• Collaborators: Georgetown University; Montefiore Medical Center; Northwestern University; Ohio State University; Texas Heart Institute; Thoratec Corporation; University of Minnesota; University of Minnesota - Clinical and Translational Science Institute; University of Pennsylvania
• Treatments: Clenbuterol

Criteria

Inclusion Criteria:

Patients with refractory symptomatic heart failure (NYHA Class IV, or Stage D) due to dilated, non-ischemic cardiomyopathy who meet the following criteria:

• Severe clinical heart failure with associated haemodynamic compromise resistant to intensive medical therapy and requiring LVAD implantation

• Duration of heart failure symptoms to be ≥ 12 months prior to LVAD implant

• Documentation of LVEF ≤ 40% at least 1 year prior to LVAD implantation

• LVEF ≤ 30% and cardiomegaly at the time of LVAD implantation as documented by radionuclide or contrast ventriculography or by echocardiography

• Nonischemic etiology confirmed by coronary angiography within two years of enrollment

• Listed for heart transplantation or plan to list for heart transplantation pending successful LVAD implantation in one of the participating centers, as per usual transplant listing policy at each participating center

• >= 18 years of age

• Body surface area >= 1.5 m2

• Have an implantable defibrillator in place or a commitment to implant an ICD prior to hospital discharge

• Have undergone insertion within prior 2 weeks or will be inserted with a Heartmate XVE LVAD with use of antimicrobial prophylaxis and drive line restraining belt

Exclusion Criteria:

• Not a heart transplant candidate

• Evidence of active acute myocarditis

• Pulmonary Vascular Resistance > 6 Wood Units

• History of previous CVA resulting in significant fixed motor deficit limiting ability to perform exercise testing

• Previous prosthetic replacement of aortic and/or mitral valve(s)

• Hypertrophic obstructive cardiomyopathy

• LVIDD < 5 cm by surface echocardiogram (restrictive cardiomyopathy)

• Irreversible multi-organ failure

• Underlying bleeding disorder, or platelet count < 75,000, INR > 2.5 (without Coumadin), or Hgb < 8.0.

• Pregnant or lactating women or unwilling to utilize two reliable methods of birth control for women of childbearing age

• Receipt of other investigational drug therapy during LVAD support