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

NCT00791843 | Completed Phase 2 Results DMC

• 2 other identifiers: Grant AG00599PP1:MGH 2004p-000099
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

CHF

Outcome Measures

Primary Outcomes (1)

• 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

  baseline, 12, 18, and 30 weeks

Study Arms (1)

GHRH and placebo

EXPERIMENTAL

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

Drug: Growth hormone releasing hormone/ placebo

Interventions

Growth hormone releasing hormone/ placebo DRUG

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.

GHRH and placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Massachusetts General Hospital/ Geriatric Research

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Growth Hormone-Releasing Hormone

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Limitations and Caveats

Data unavailable for study, PI is deceased and all staff associated with study have left the institution.

Results Point of Contact

• Title: Tyrone Quarterman
• Organization: University of Pennsylvania

tyroneq@upenn.edu

215-349-5537

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2008
• First Posted: November 17, 2008
• Study Start: March 1, 2004
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: July 9, 2019
• Results First Posted: July 9, 2019

Record last verified: 2019-06

Locations

US (1)