Chronic Heart FailurePhase 3NCT00501514
Effects of Growth Hormone on Exercise Capacity
A Phase 3 study testing Growth hormone in people with Chronic Heart Failure, run by Federico II University at 1 site in Italy.
Trial summary
The purpose of this study was to assess whether Growth Hormone(GH)improves exercise capacity and cardiopulmonary performance in patients with chronic heart failure. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- Growth hormone
- How many people
- 22 participants
- Where
- 1 siteItaly
- Study dates
- Nov 1997to Nov 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ejection fraction < 40%
- Left ventricular internal dimension >58 mm
- II-III NYHA class
- Stable hemodynamic condition during the previous three months
- Sinus rhythm
Who cannot join
- IMA or CABG or PTCA in the previous six months
- Instable angina
- Major arrhythmias (Lown class> IV)
- Diseases limiting exercise capacity
- Insulin treated diabetes mellitus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Growth Hormone on Exercise Capacity and Cardiopulmonary Performance in Patients With Chronic Heart Failure
The purpose of this study was to assess whether Growth Hormone(GH)improves exercise capacity and cardiopulmonary performance in patients with chronic heart failure.
Read the detailed description
clinical studies have focused the effects of GH on left ventricular function and hemodynamics. Little is known about the impact of GH on cardiopulmonary performance and exercise capacity. Such data would be relevant, given the well-recognized importance of cardiopulmonary performance and exercise capacity as markers of disease progression and predictors of mortality in patients with CHF.Consequently we conducted a randomised double blind placebo controlled trial to investigate the effects of a three month course of GH, adjunctive to background therapy, on cardiopulmonary performance and exercise capacity in patients with dilated cardiomyopathy and CHF.The primary outcome of the study was improvement of peak VO2 assessed by a cardiopulmonary exercise testing. Secondary endpoints were exercise capacity and ejection fraction obtained by echocardiography.
- Conditions
- Chronic Heart Failure
- Being tested
- Growth hormone
- Keywords
- chronic heart failure, cardiopulmonary exercise, oxygen consumption, growth hormone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Growth hormoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome of the study was improvement of peak VO2 assessed by a cardiopulmonary exercise testing.
Measured: three months
Secondary outcomes (1)
Secondary endpoints were exercise capacity and ejection fraction obtained by echocardiography.
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2007 (estimated)
- Study startNov 1997
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Investigators
- Luigi Saccà, MD, Principal investigator, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00501514
- Sponsor's protocol ID
- CTN 96-0870-001
- Status last verified
- Jan 2009
- First submitted
- 12 Jul 2007
- Last updated
- 29 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fazio S, Sabatini D, Capaldo B, Vigorito C, Giordano A, Guida R, Pardo F, Biondi B, Sacca L. A preliminary study of growth hormone in the treatment of dilated cardiomyopathy. N Engl J Med. 1996 Mar 28;334(13):809-14. doi: 10.1056/NEJM199603283341301.
PubMed 8596546Genth-Zotz S, Zotz R, Geil S, Voigtlander T, Meyer J, Darius H. Recombinant growth hormone therapy in patients with ischemic cardiomyopathy : effects on hemodynamics, left ventricular function, and cardiopulmonary exercise capacity. Circulation. 1999 Jan 5-12;99(1):18-21. doi: 10.1161/01.cir.99.1.18.
PubMed 9884373Osterziel KJ, Strohm O, Schuler J, Friedrich M, Hanlein D, Willenbrock R, Anker SD, Poole-Wilson PA, Ranke MB, Dietz R. Randomised, double-blind, placebo-controlled trial of human recombinant growth hormone in patients with chronic heart failure due to dilated cardiomyopathy. Lancet. 1998 Apr 25;351(9111):1233-7. doi: 10.1016/S0140-6736(97)11329-0.
PubMed 9643742
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Growth Hormone on Exercise Capacity and Cardiopulmonary Performance in Patients With Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT00501514
- Acronym / sponsor ID
- CTN 96-0870-001
- Conditions
- Chronic Heart Failure
- Keywords
- chronic heart failure, cardiopulmonary exercise, oxygen consumption, growth hormone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Nov 1997
- Study completion
- Nov 2005 (actual)
- First posted
- 16 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to assess whether Growth Hormone(GH)improves exercise capacity and cardiopulmonary performance in patients with chronic heart failure.
Detailed description
clinical studies have focused the effects of GH on left ventricular function and hemodynamics. Little is known about the impact of GH on cardiopulmonary performance and exercise capacity. Such data would be relevant, given the well-recognized importance of cardiopulmonary performance and exercise capacity as markers of disease progression and predictors of mortality in patients with CHF.Consequently we conducted a randomised double blind placebo controlled trial to investigate the effects of a three month course of GH, adjunctive to background therapy, on cardiopulmonary performance and exercise capacity in patients with dilated cardiomyopathy and CHF.The primary outcome of the study was improvement of peak VO2 assessed by a cardiopulmonary exercise testing. Secondary endpoints were exercise capacity and ejection fraction obtained by echocardiography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ejection fraction < 40%
- Left ventricular internal dimension >58 mm
- II-III NYHA class
- Stable hemodynamic condition during the previous three months
- Sinus rhythm
Key exclusion criteria (5 listed)
- IMA or CABG or PTCA in the previous six months
- Instable angina
- Major arrhythmias (Lown class> IV)
- Diseases limiting exercise capacity
- Insulin treated diabetes mellitus
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 | Drug | – |
Primary outcome
The primary outcome of the study was improvement of peak VO2 assessed by a cardiopulmonary exercise testing.
Time frame: three months
1 secondary outcome
Secondary endpoints were exercise capacity and ejection fraction obtained by echocardiography.
Time frame: three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2009.
- Background: PubMed 8596546Fazio S, Sabatini D, Capaldo B, Vigorito C, Giordano A, Guida R, Pardo F, Biondi B, Sacca L. A preliminary study of growth hormone in the treatment of dilated cardiomyopathy. N Engl J Med. 1996 Mar 28;334(13):809-14. doi: 10.1056/NEJM199603283341301.
- Background: PubMed 9884373Genth-Zotz S, Zotz R, Geil S, Voigtlander T, Meyer J, Darius H. Recombinant growth hormone therapy in patients with ischemic cardiomyopathy : effects on hemodynamics, left ventricular function, and cardiopulmonary exercise capacity. Circulation. 1999 Jan 5-12;99(1):18-21. doi: 10.1161/01.cir.99.1.18.
- Background: PubMed 9643742Osterziel KJ, Strohm O, Schuler J, Friedrich M, Hanlein D, Willenbrock R, Anker SD, Poole-Wilson PA, Ranke MB, Dietz R. Randomised, double-blind, placebo-controlled trial of human recombinant growth hormone in patients with chronic heart failure due to dilated cardiomyopathy. Lancet. 1998 Apr 25;351(9111):1233-7. doi: 10.1016/S0140-6736(97)11329-0.
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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.
Luigi Saccà, MD principal investigator
Federico II University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Growth hormone in people with Chronic Heart Failure, run by Federico II University at 1 site in Italy.
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 5 inclusion and 5 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 29 Jan 2009. 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 Italy. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary outcome of the study was improvement of peak VO2 assessed by a cardiopulmonary exercise testing. (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00501514, which also lists 3 linked publications.
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 29 Jan 2009.