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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 |
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 |
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. |
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.
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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.
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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
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Laura Yamokoski, RN, MA | 614-247-7796 | Laura.Yamokoski@osumc.edu |
Contact: Leah Sanuk, RN | 614-292-6789 | Leah.Sanuk@osumc.edu |
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 |
Ohio State University |
Massachusetts General Hospital |
Montefiore Medical Center |
Northwestern University |
Texas Heart Institute |
University of Michigan |
Washington Hospital Center |
Principal Investigator: | David S Feldman, MD/PhD | Ohio State University |
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 |
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