Phase 2
N=3
The Effect of GHRH Therapy on Myocardial Structure and Function in Congestive Heart Failure
Congestive Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT00791843 ↗Enrolled (actual)
3
Serious AEs
—
Results posted
Jul 2019
Primary outcome: Primary: 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
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Growth hormone releasing hormone/ placebo (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
— | — |
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.
Eligibility Criteria
INCLUSION CRITERIA
- 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
- a left ventricular ejection fraction below 40% as measured by echocardiogram performed within 6 months of study enrollment.
- 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
- hemodynamically stable and able to complete symptom-limited bicycle ergometry exercise test;
- and be in New York Heart Association Classification II or III.
EXCLUSION CRITERIA
- Subjects with hematocrit equal to or less than 33%;
- 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;
- known or suspected myocarditis;
- known or suspected restrictive or infiltrative cardiomyopathy;
- coronary artery stenosis >70% and 2.0.
- untreated thyroid disease;
- active alcoholism,
- breast cancer;
- prostate cancer;
- inability to provide informed consent;
- uncontrolled hyperlipidemia; (Triglycerides >1200 and/or LDL > 160)
- patients with known bleeding disorders;
- patients using atropine, artane, scopolamine, and cogentin.
- Subjects who have implanted devices that contain metal and are not adherent to the body will be excluded from the MRI testing in this study. These devices include pacemakers, implanted ICD's, infusion pumps, nerve stimulators, metal debris in the eye, or loose metal, such as shrapnel or a bullet.
- Inability to lie flat on back for an extended period of time. The MRI testing requires this posture.
- History of any noncutaneous malignancy within 5 years of screening.
STUDY TERMINATION CRITERIA:
The following clinical events will define drop-points for worsening clinical conditions and will terminate subject involvement in the study:
- Unstable angina
- Acute myocardial infarction (chest pain with EKG changes and increased troponin)
- NYHA Class IV heart failure for greater than one week (a brief episode of NYHA Class IV heart failure may result from medical or dietary indiscretion, adverse effects of non-study medications, poorly controlled hypertension and other potentially reversible mechanisms)
- Documented sustained ventricular tachycardia
- Resuscitated cardiac arrest
- Unexplained syncope
- Diagnosis of sleep apnea that is not medically supervised.
- Symptomatic documented bradycardia
- Diagnosis of a new non-cutaneous malignancy
- Developing exclusion criteria
- Stroke
- Death
Data sourced from ClinicalTrials.gov (NCT00791843). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.