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Sponsors and Collaborators: |
Massachusetts General Hospital Johns Hopkins University |
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Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00791843 |
PP1- The purpose of this study is to determine whether giving more of the hormone produced by everyone called growth hormone releasing hormone (GHRH) can improve heart function in individuals with congestive heart failure. You must be 50 years old or older, have a diagnosis of congestive heart failure, and have a high likelihood of having lower than normal growth hormone effect. GHRH is approved by the US FDA for treatment in children with growth hormone deficiency because GHRH stimulates Growth Hormone (GH). Its use for treatment of congestive heart failure in adults is investigational.
Growth hormone releasing hormone is a hormone produced in the brain. We will be using synthetic hormone made in the laboratory. It is identical to the hormone in the brain.
Many older people, due to aging have low levels of growth hormone. The aim of this study is to find out whether restoring growth hormone levels to the levels found in younger individuals and then maintaining those levels for 12 weeks will help strengthen heard muscles in older persons with congestive heart failure.
Condition | Intervention | Phase |
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Congestive Heart Failure |
Drug: Growth hormone releasing hormone/ placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | The Effect of GHRH Therapy on Myocardial Structure and Function in Congestive Heart Failure |
Estimated Enrollment: | 10 |
Study Start Date: | March 2004 |
Estimated Study Completion Date: | August 2010 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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GHRH and placebo: Experimental
Everyone will receive 12 weeks of GHRH and 12 weeks of Placebo
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Drug: Growth hormone releasing hormone/ placebo
12 weeks of drug at max dose of 2mg/day administered in 4 pulses at 11pm, 1am, 3am, and 5am, followed by 6 weeks of washout period, then 12 weeks of placebo or vise versa- 12 weeks of placebo, 6 weeks washout, 12 weeks of drug.
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PP1- The overall purpose of this study is to evaluate the effects of Growth Hormone Releasing Hormone (GHRH) on cardiac structure and function in subjects aged 50 years and older with a diagnosis of congestive heart failure in a single blinded (to the subject) randomized treatment/placebo study design. They will receive 12 weeks of drug or placebo, 6 weeks of washout, and 12 weeks of placebo or drug- whichever they didn't receive in the first 12 weeks. The hypotheses are: 1)normal aging is associated with evidence of declining somatotrophic activity exemplified by IGF-1 levels; 2) GHRH can raise levels of Growth hormone and IGF-1 in elderly individuals in a dose dependent fashion with minimal delecterious side effects; 3) GHRH will produce measurable increments in myocardial performance and structure and demonstrated growth of peripheral musculature; 4) the combination of these benefits will result in better quality of life due to the improvement of overall cardiac function.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
STUDY TERMINATION CRITERIA:
The following clinical events will define drop-points for worsening clinical conditions and will terminate subject involvement in the study:
Contact: Kenneth L Minaker, MD | 617-726-4633 | kminaker@partners.org |
United States, Massachusetts | |
Massachusetts General Hospital/ Geriatric Research | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Kenneth L Minaker, M.D. 617-726-4633 kminaker@partners.org | |
Contact: Dariush Elahi, PhD delahi@partners.org | |
Principal Investigator: Kenneth L Minaker, M.D. |
Responsible Party: | Massachusetts General Hospital ( Kenneth L Minaker M.D./ Chief of Geriatric Medicine Unit, Associate Professor of Medicine ) |
Study ID Numbers: | Grant AG00599, PP1:MGH 2004p-000099 |
Study First Received: | November 13, 2008 |
Last Updated: | November 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00791843 |
Health Authority: | United States: Food and Drug Administration |
CHF |
Heart Failure Heart Diseases Growth Hormone-Releasing Hormone |
Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Cardiovascular Diseases Hormones Pharmacologic Actions |