The Effect of GHRH Therapy on Myocardial Structure and Function in Congestive Heart Failure (GHRH)
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.
|Congestive Heart Failure||Drug: Growth hormone releasing hormone/ placebo||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
|Official Title:||The Effect of GHRH Therapy on Myocardial Structure and Function in Congestive Heart Failure|
- PP1- Serum IGF-1 levels, DXA, Resting Metabolic Rate, Total Body Water, 3-D echo, Cardiac MRI, Dobutamine Stress Echocardiogram, Ergometry, General Health Assessment, Physical Exam [ Time Frame: baseline, 12, 18, and 30 weeks ]
|Study Start Date:||March 2004|
|Study Completion Date:||August 2011|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
Experimental: GHRH and placebo
Everyone will receive 12 weeks of GHRH and 12 weeks of Placebo
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00791843
|United States, Massachusetts|
|Massachusetts General Hospital/ Geriatric Research|
|Boston, Massachusetts, United States, 02114|