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

What Was Tested

This registered phase 2 trial tested GHRH (Growth Hormone-Releasing Hormone).

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).

It had 1 arm (groups): GHRH and placebo (experimental).

Everyone will receive 12 weeks of GHRH and 12 weeks of Placebo.

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

The registry lists 3 actual participants took part.

It was open to people of any sex aged from 50 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Subjects will be at least 50 years of age,. Women who are post-menopausal. Clinical evidence of congestive heart failure, with ongoing management by conventional medical therapy. Left ventricular end-diastolic dimension greater than 60 mm as measured by an echocardiogram performed within 6 months of study enrollment. Regular heart rate/pacer.

The full record lists 8 inclusion and 38 exclusion criteria; among the exclusions: body mass index equal to or greater than 40;; unstable angina within six months;; inducible ischemia by exercise stress testing, radionuclide scintigraphy, or dobutamine echocardiography;.

How the Study Was Run

Design: randomized, crossover and single-blind.

Because people in this GHRH (Growth Hormone-Releasing Hormone) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Each person switched between GHRH (Growth Hormone-Releasing Hormone) and the comparison at some point, usually with a gap in between.

Only one side, usually the participants, was kept unaware of whether GHRH (Growth Hormone-Releasing Hormone) was given.

Those kept unaware of assignments: participant.

It started in 2004-03 with completion listed for 2011-08.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: 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).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of GHRH (Growth Hormone-Releasing Hormone) in 3 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the GHRH (Growth Hormone-Releasing Hormone) compound page, all human trials.