Growth Hormone DeficiencyPhase 2NCT01576861
Long-Term Efficacy and Safety of Growth Hormone Replacement Therapy in Chronic Heart Failure
A Phase 2 study testing Somatotropin in people with Growth Hormone Deficiency and Chronic Heart Failure, run by Federico II University at 1 site in Italy.
Trial summary
After the encouraging results of 6 months of Growth Hormone Replacement Therapy in Patients With Chronic Heart Failure and Coexisting Growth Hormone Deficiency (NCT00591760) the investigators wanted to collect data about the long-term efficacy and safety of this kind of therapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Growth Hormone Deficiency, Chronic Heart Failure
- What is being tested?
- Somatotropin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2007to Dec 2011
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic Heart Failure New York Heart Association functional class II to IV, secondary to ischemic or idiopathic cardiomyopathy
- Age range 18-80 years
- Stable medication for at least one month including beta-blockers that had to be started at least 5 months before entering the study
- Left Ventricular ejection fraction 40% or less
- Growth Hormone Deficiency (defined as a peak GH response to intravenous stimulation with GHRH + Arginine < 9 ng/ml)
- Written Informed consent
Who cannot join
- Acute proliferative or severe non-proliferative diabetic retinopathy
- Active malignancy
- Evidence of progression or recurrence of an underlying intracranial tumor
- Unstable Angina or recent myocardial infarction
- Serum Creatinine levels > 2.5 mg/dl
- Severe liver disease (Child-Pugh B-C)
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Internal Medicine, Cardiovascular and Immunological Sciences
Naples, Campania, 80131
About this study
After the encouraging results of 6 months of Growth Hormone Replacement Therapy in Patients With Chronic Heart Failure and Coexisting Growth Hormone Deficiency (NCT00591760) the investigators wanted to collect data about the long-term efficacy and safety of this kind of therapy.
- Conditions
- Growth Hormone Deficiency, Chronic Heart Failure
- Being tested
- Somatotropin
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SomatotropinDrug
Subcutaneous Somatotropin (recombinant Human Growth Hormone) 0,012 mg/kg every second day
| Study group | Role | What they receive |
|---|---|---|
| GH replacement | Experimental | Patients will receive 48 months of substitutive somatotropin (growth hormone) therapy at a dose of 0,012 mg/kg every second day, added to their background optimized CHF therapy Receives: Drug: Somatotropin |
| Control CHF patients under optimized CHF therapy | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Oxygen Consumption
Measured: after 48 months
Side effects
Measured: Any side effects recorded after 6,24 and 48 months
Secondary outcomes (4)
Left Ventricular Ejection Fraction
Measured: after 48 months
Left Ventricular End-Systolic Volume
Measured: after 48 months
Left Ventricular End-Diastolic Volume
Measured: after 48 months
Quality of Life
Measured: after 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2012 (estimated)
- Study startJan 2007
- Primary completionMar 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth Hormone DeficiencyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Cittadini, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01576861
- Sponsor's protocol ID
- Long-Term GH in CHF
- Status last verified
- Oct 2012
- First submitted
- 19 Mar 2012
- Last updated
- 18 Oct 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Efficacy and Safety of Growth Hormone Replacement Therapy in Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT01576861
- Acronym / sponsor ID
- Long-Term GH in CHF
- Conditions
- Growth Hormone Deficiency, Chronic Heart Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Mar 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 13 Apr 2012 (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.
After the encouraging results of 6 months of Growth Hormone Replacement Therapy in Patients With Chronic Heart Failure and Coexisting Growth Hormone Deficiency (NCT00591760) the investigators wanted to collect data about the long-term efficacy and safety of this kind of therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GH replacement | Experimental | Drug: SomatotropinPatients will receive 48 months of substitutive somatotropin (growth hormone) therapy at a dose of 0,012 mg/kg every second day, added to their background optimized CHF therapy |
| Control CHF patients under optimized CHF therapy | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Chronic Heart Failure New York Heart Association functional class II to IV, secondary to ischemic or idiopathic cardiomyopathy
- Age range 18-80 years
- Stable medication for at least one month including beta-blockers that had to be started at least 5 months before entering the study
- Left Ventricular ejection fraction 40% or less
- Growth Hormone Deficiency (defined as a peak GH response to intravenous stimulation with GHRH + Arginine < 9 ng/ml)
Key exclusion criteria (6 listed)
- Acute proliferative or severe non-proliferative diabetic retinopathy
- Active malignancy
- Evidence of progression or recurrence of an underlying intracranial tumor
- Unstable Angina or recent myocardial infarction
- Serum Creatinine levels > 2.5 mg/dl
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 |
|---|---|---|
| SomatotropinSubcutaneous Somatotropin (recombinant Human Growth Hormone) 0,012 mg/kg every second day | Drug | GH replacement |
Primary outcome
Peak Oxygen Consumption
Time frame: after 48 months
Side effects
Time frame: Any side effects recorded after 6,24 and 48 months
4 secondary outcomes
Left Ventricular Ejection Fraction
Time frame: after 48 months
Left Ventricular End-Systolic Volume
Time frame: after 48 months
Left Ventricular End-Diastolic Volume
Time frame: after 48 months
Quality of Life
Time frame: after 48 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 18 Oct 2012.
Related trials for Growth Hormone Deficiency
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Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children
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RecruitingPhase 3
Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)
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Enrolling by invitationObservational study
Influence of Adherence to Growth Hormone Therapy (GHT) With Norditropin® on Near Final Height in Patients With Growth Hormone Deficiency (GHD) and Born Small for Gestational Age (SGA)
Growth Hormone Deficiency in Children, Born Small for Gestational Age
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 testing Somatotropin in people with Growth Hormone Deficiency and 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 6 inclusion and 6 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 18 Oct 2012. 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 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?
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?
Peak Oxygen Consumption (time frame: after 48 months). The study lists 2 primary outcomes in all. 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 18 Oct 2012.