Congestive Heart FailurePhase 2GHRHNCT00791843
The Effect of GHRH Therapy on Myocardial Structure and Function in Congestive Heart Failure
A Phase 2 study of Congestive Heart Failure, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Congestive Heart Failure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Aug 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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
- 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.
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital/ Geriatric Research
Boston, Massachusetts, 02114
About this study
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.
Read the detailed description
PP1- The overall purpose of this study is to evaluate the effects of Growth Hormone Releasing Hormone (GHRH) on cardiac structure and function in subjects aged 50 years and older with a diagnosis of congestive heart failure in a single blinded (to the subject) randomized treatment/placebo study design. 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. The hypotheses are: 1)normal aging is associated with evidence of declining somatotrophic activity exemplified by IGF-1 levels; 2) GHRH can raise levels of Growth hormone and IGF-1 in elderly individuals in a dose dependent fashion with minimal deleterious side effects; 3) GHRH will produce measurable increments in myocardial performance and structure and demonstrated growth of peripheral musculature; 4) the combination of these benefits will result in better quality of life due to the improvement of overall cardiac function.
- Conditions
- Congestive Heart Failure
- Being tested
- Growth hormone releasing hormone/ placebo
- Keywords
- CHF
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Growth hormone releasing hormone/ placeboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| GHRH and placebo | Experimental | Everyone will receive 12 weeks of GHRH and 12 weeks of Placebo Receives: Drug: Growth hormone releasing hormone/ placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline, 12, 18, and 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2008 (estimated)
- Study startMar 2004
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00791843
- Sponsor's protocol ID
- Grant AG00599
- Other IDs
- PP1:MGH 2004p-000099
- Acronym
- GHRH
- Status last verified
- Jun 2019
- First submitted
- 13 Nov 2008
- Last updated
- 9 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of GHRH Therapy on Myocardial Structure and Function in Congestive Heart Failure
- ClinicalTrials.gov ID
- NCT00791843
- Acronym / sponsor ID
- GHRH / Grant AG00599
- Conditions
- Congestive Heart Failure
- Keywords
- CHF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Mar 2004
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 17 Nov 2008 (estimated)
- Results
- Posted 9 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PP1- The overall purpose of this study is to evaluate the effects of Growth Hormone Releasing Hormone (GHRH) on cardiac structure and function in subjects aged 50 years and older with a diagnosis of congestive heart failure in a single blinded (to the subject) randomized treatment/placebo study design. 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. The hypotheses are: 1)normal aging is associated with evidence of declining somatotrophic activity exemplified by IGF-1 levels; 2) GHRH can raise levels of Growth hormone and IGF-1 in elderly individuals in a dose dependent fashion with minimal deleterious side effects; 3) GHRH will produce measurable increments in myocardial performance and structure and demonstrated growth of peripheral musculature; 4) the combination of these benefits will result in better quality of life due to the improvement of overall cardiac function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GHRH and placebo | Experimental | Drug: Growth hormone releasing hormone/ placeboEveryone will receive 12 weeks of GHRH and 12 weeks of Placebo |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (40 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Growth hormone releasing hormone/ placebo12 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. | Drug | GHRH and placebo |
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Congestive Heart Failure, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2019.