MedTrace Logo

The Effect of GHRH Therapy on Myocardial Structure and Function in Congestive Heart Failure

NCT00791843 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2019-07-09

Study results available
· View outcomes & findings →

Summary

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.

Conditions

  • Congestive Heart Failure

Interventions

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-03-31
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00791843 on ClinicalTrials.gov