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

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 < 100% by catheterization should such data be available;
inadequate cardiac echo window;
primary diastolic dysfunction in heart failure
inability to perform cycle ergometry;
critical aortic stenosis;
severe mitral regurgitation by Doppler echocardiography;
uncontrolled or poorly controlled hypertension;
hypertrophic cardiomyopathy;
renal failure, determined by creatinine > 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