Safety Study of Clenbuterol in Combination With Left Ventricular Assist Device to Treat Chronic Heart Failure - Full Text View

Purpose

To test whether patients that have recently received an Left Ventricular Assist Device (LVAD) for the treatment of their heart failure can recover enough heart function to have the LVAD removed and not need a heart transplant. We are testing the drug, Clenbuterol, which is currently approved in Europe as a bronchodilator (a medication that opens the airway of the lungs), but its use in heart function is still being evaluated.

Condition	Intervention	Phase
Heart Failure Nonischemic Cardiomyopathy Cardiac Disease	Drug: Clenbuterol	Phase I Phase II

MedlinePlus related topics:

Cardiomyopathy Heart Diseases Heart Failure

Drug Information available for:

Clenbuterol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Official Title:	Harefield Recovery Protocol Study - Evaluation of Potential Recovery of Heart Function in Patients With Refractory Chronic Heart Failure.

Further study details as provided by Ohio State University:

Primary Outcome Measures:

To determine if the proportion of subjects treated with the HARPS protocol who Experience LVAD removal and subsequent freedom from mechanical circulatory support or heart transplantation for 1 year post-LVAD removal. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To asses the effect of the HARP regimen on LVAD explantation and the changes to the heart [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	March 2007
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Non-randomized, open-label, trial that will evaluate patients with severe heart failure who require left ventricular assistance to stay alive.	Drug: Clenbuterol In conjunction with the implantation of the LVAD, subjects will receive standard heart failure treatment and clinical exercise training. The patients will be given Clenbuterol to assist in Oxygen circulation and will have their heart failure status monitored over the course of a year.

Detailed Description:

A non-randomized, Open Label Multi-Center Evaluation of Potential Recovery of Heart Function in Patients with Refractory Chronic Heart Failure by Treatment with a Combination of Left Ventricular Assist Device (LVAD) Drugs to Induce Maximal Reverse Remodeling, and the Beta-2 Adrenergic Receptor Agonist, Clenbuterol

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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
Body surface area greater than 1.5 meters squared
All patients will have an implantable defibrillator in place or 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00701116

Contacts


Contact: Laura Yamokoski, RN, MA	614-247-7796	Laura.Yamokoski@osumc.edu

Contact: Leah Sanuk, RN	614-292-6789	Leah.Sanuk@osumc.edu

Locations


United States, District of Columbia
	Washington Hospital Center	Recruiting
	Washington, District of Columbia, United States, 20010
	Contact: Leslie c Sweet, RN 202-877-7602 Leslie.C.Sweet@medstar.net
	Principal Investigator: Les Miller, MD

United States, Illinois
	Northwestern University	Recruiting
	Chicago, Illinois, United States, 60611
	Contact: Anna Huskin, RN 312-695-4067 ahuskin@nmh.org
	Principal Investigator: John O'Connell, MD

United States, Massachusetts
	Massachusetts General Hospital	Recruiting
	Boston, Massachusetts, United States, 02114
	Contact: Stephanie A Moore, MD 617-724-1400
	Principal Investigator: Stephanie A Moore, MD

United States, Michigan
	University of Michigan	Recruiting
	Ann Arbor, Michigan, United States, 48109
	Contact: Tina Leventhal, MS 734-647-7958 tinalev@med.umich.edu
	Principal Investigator: Francis Pagani, MD, PhD
	Sub-Investigator: Keith Aaronson, MD

United States, New York
	Montefiore Medical Center	Recruiting
	Bronx, New York, United States, 10467
	Contact: Gayathri Kamalakkannan 718-920-6575 gkamalak@montefiore.org
	Principal Investigator: Simon Maybaum, MD
	Sub-Investigator: Daniel Spevack, MD

United States, Ohio
	The Ohio State University Medical Center	Recruiting
	Columbus, Ohio, United States, 43210
	Contact: Leah Sanuk, RN 614-292-6789 Leah.Sanuk@osumc.edu

United States, Texas
	Texas Heart Institute	Recruiting
	Houston, Texas, United States, 77030
	Contact: Kathy Vershave, RN 832-355-8520 kvershave@heart.thi.tmc.edu
	Principal Investigator: Roberta Bogaev, MD

Sponsors and Collaborators

Ohio State University

Massachusetts General Hospital

Montefiore Medical Center

Northwestern University

Texas Heart Institute

University of Michigan

Washington Hospital Center

Investigators


Principal Investigator:	David S Feldman, MD/PhD	Ohio State University

More Information

Responsible Party:	The Ohio State University ( David Feldman, MD, PhD, FACC )
Study ID Numbers:	2007H0101
First Received:	June 17, 2008
Last Updated:	June 18, 2008
ClinicalTrials.gov Identifier:	NCT00701116
Health Authority:	United States: Food and Drug Administration

Keywords provided by Ohio State University:

Left Ventricular Assist Device

Heart Failure

NonIschemic cardiomyopathy

Cardiac Disease

Study placed in the following topic categories:

Heart Failure

Heart Diseases

Cardiomyopathies

Clenbuterol

Additional relevant MeSH terms:

Respiratory System Agents

Neurotransmitter Agents

Adrenergic beta-Agonists

Adrenergic Agents

Molecular Mechanisms of Pharmacological Action

Sympathomimetics

Physiological Effects of Drugs

Anti-Asthmatic Agents

Adrenergic Agonists

Pharmacologic Actions

Autonomic Agents

Therapeutic Uses

Cardiovascular Diseases

Peripheral Nervous System Agents

Bronchodilator Agents

ClinicalTrials.gov processed this record on October 24, 2008

Sponsors and Collaborators:	Ohio State University Massachusetts General Hospital Montefiore Medical Center Northwestern University Texas Heart Institute University of Michigan Washington Hospital Center
Information provided by:	Ohio State University
ClinicalTrials.gov Identifier:	NCT00701116