Harefield Recovery Protocol Study for Patients With Refractory Chronic Heart Failure

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.

Conditions

• Heart Failure
• Dilated Cardiomyopathy

Interventions

DRUG

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.

Sponsors & Collaborators

• Georgetown University

  collaborator OTHER

• Montefiore Medical Center

  collaborator OTHER

• Northwestern University

  collaborator OTHER

• Ohio State University

  collaborator OTHER

• Texas Heart Institute

  collaborator OTHER

• University of Minnesota

  collaborator OTHER

• University of Pennsylvania

  collaborator OTHER

• Thoratec Corporation

  collaborator INDUSTRY

• Francis D. Pagani

  lead OTHER

Principal Investigators

• Leslie W. Miller, MD · Georgetown University

• Keith D. Aaronson, MD, MS · University of Michigan

• Francis D. Pagani, MD, PhD · University of Michigan

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-07-31

Primary Completion

2010-03-31

Completion

2010-03-31

FDA Drug

Yes

Countries

• United States

Study Locations