Heart FailurePhase 3NCT03775993
Treatment of GHD Associated With CHF
A Phase 3 study testing Human growth hormone in people with Heart Failure and Growth Hormone Deficiency, run by Federico II University.
Trial summary
Aim of the current study is to assess the cardiovascular effects of GH replacement therapy in patients with coexisting GHD and CHF Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Heart Failure, Growth Hormone Deficiency
- What is being tested?
- Human growth hormone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2019to 1 Mar 2022
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients of either sex affected by CHF NYHA class I-III, secondary to ischemic or idiopathic di-lated cardiomyopathy;
- age range 18-85 years;
- stable and optimal medical therapy for at least three months prior to randomization, including ACE inhibitors or AT1 antagonists and beta-blockers (unless untolerated);
- LV ejection fraction 40% or less and LV end-diastolic dimension 55 mm or more;
- GH deficiency diagnosed with GHRH + arginine provocative test;
- signed informed consent.
Who cannot join
- inability to perform a bicycle exercise test;
- poorly controlled diabetes mellitus (HbA1c >8.5) and/or active proliferative or severe non-proliferative diabetic retinopathy;
- active and/or history of malignancy;
- unstable angina or recent myocardial infarction (less than six months);
- severe liver or kidney disease (serum creatinine levels >2.5 mg/dl
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Treatment of Growth Hormone Deficiency Associated With Chronic Heart Failure: A Randomized, Double-Blind, Placebo-Controlled Study
Aim of the current study is to assess the cardiovascular effects of GH replacement therapy in patients with coexisting GHD and CHF
Read the detailed description
Multiple anabolic deficiencies are common in chronic heart failure (CHF) and identify subgroups of patients with higher mortality. Apart from CHF, GH deficiency (GHD) per se increases cardiovascular mortality in the general population and low IGF-1 levels in the general population predict the development of ischemic heart disease and CHF. GHD modifies cardiac size and function, through a reduction in both myocardial growth and cardiac performance. The investigators therefore completed 2 studies aimed at evaluating the clinical status, neurohormonal parameters, exercise capacity, vascular reactivity, and left ventricular architecture and function in patients with GHD and CHF, at baseline and after 6 months of GH replacement therapy. They subsequently extended the observation period up to 48 months. At 6-months, GH replacement therapy improved clinical status and exercise capacity, as shown by a significant reduction of the Minnesota living with heart failure questionnaire score, increased peak oxygen consumption and exercise duration, and flow mediated vasodilation of the brachial artery. No major adverse events were reported in the patients receiving GH.
However, the encouraging results of these studies are limited by the lack of a double-blind, placebo-controlled design, insofar as the investigators performed a randomized controlled, single-blind study.
- Conditions
- Heart Failure, Growth Hormone Deficiency
- Being tested
- Human growth hormone, Placebo
- Keywords
- Growth Hormone, Placebo, Exercise capacity, Vascular reactivity, LV function, Prognosis
- Medical subject headings
- Heart Failure, Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human growth hormoneDrug
Administration of growth hormone
PlaceboOther
Administration of placebo
| Study group | Role | What they receive |
|---|---|---|
| GHD | Active comparator | Not described Receives: Drug: Human growth hormone |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of peak oxygen consumption (peak VO2)
According to previous observations, the investigators set a target increase of peak VO2 in the treated arm at 3 ml/kg/min at the end of the study
Measured: 1 year
Secondary outcomes (8)
Number of Hospitalizations
Measured: 1 year
End-systolic LV volumes
Measured: 1 year
NT-proBNP levels
Measured: 1 year
Quality of life score from the Minnesota Living with Heart Failure Questionnaire
The questionnaire is comprised of 21 physical, emotional and socioeconomic questions that may adversely affect a patient's life. After receiving brief standardized instructions, the patient marks a 0 (lower valure) to 5 (upper value) scale to indicate how much each itemized adverse of heart failure has prevented the patient from living as he or she wanted to live during the past 4 weeks. The final score is calculated by sum.
Measured: 1 year
Evaluation of Endothelial function (flow-mediated vasodilation)
Measured: 1 year
Muscle strength (handgrip)
Measured: 1 year
Evaluation of the Levels of Endothelial Progenitor Cells (EPCs)
Measured: 1 year
Evaluation of the Levels of lymphocyte G protein-coupled receptor kinase (GRK)-2
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2018
- Study start1 Mar 2019 (estimated)
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
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
- NCT03775993
- Sponsor's protocol ID
- 2016-004580-39
- Other IDs
- 2016
- Status last verified
- Feb 2019
- First submitted
- 12 Dec 2018
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marra AM, D'Assante R, De Luca M, Arcopinto M, Gargiulo P, Valente V, Crisci G, Rainone C, Modestino M, Giardino F, Paolillo S, Cacciatore F, Saldamarco L, Bruzzese D, Scarpa D, Filardi PP, Esposito G, Sacca L, Bossone E, Salzano A, Cittadini A. Growth Hormone Replacement Therapy in Heart Failure With Reduced Ejection Fraction: A Randomized, Double-Blind, Placebo-Controlled Trial. JACC Heart Fail. 2025 Apr;13(4):602-614. doi: 10.1016/j.jchf.2024.11.017. Epub 2025 Mar 5.
PubMed 40047762
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Growth Hormone Deficiency Associated With Chronic Heart Failure: A Randomized, Double-Blind, Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT03775993
- Acronym / sponsor ID
- 2016-004580-39
- Conditions
- Heart Failure, Growth Hormone Deficiency
- Keywords
- Growth Hormone, Placebo, Exercise capacity, Vascular reactivity, LV function, Prognosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (estimated)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 14 Dec 2018 (actual)
- 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.
Aim of the current study is to assess the cardiovascular effects of GH replacement therapy in patients with coexisting GHD and CHF
Detailed description
Multiple anabolic deficiencies are common in chronic heart failure (CHF) and identify subgroups of patients with higher mortality. Apart from CHF, GH deficiency (GHD) per se increases cardiovascular mortality in the general population and low IGF-1 levels in the general population predict the development of ischemic heart disease and CHF. GHD modifies cardiac size and function, through a reduction in both myocardial growth and cardiac performance. The investigators therefore completed 2 studies aimed at evaluating the clinical status, neurohormonal parameters, exercise capacity, vascular reactivity, and left ventricular architecture and function in patients with GHD and CHF, at baseline and after 6 months of GH replacement therapy. They subsequently extended the observation period up to 48 months. At 6-months, GH replacement therapy improved clinical status and exercise capacity, as shown by a significant reduction of the Minnesota living with heart failure questionnaire score, increased peak oxygen consumption and exercise duration, and flow mediated vasodilation of the brachial artery. No major adverse events were reported in the patients receiving GH.
However, the encouraging results of these studies are limited by the lack of a double-blind, placebo-controlled design, insofar as the investigators performed a randomized controlled, single-blind study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GHD | Active comparator | Drug: Human growth hormone |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patients of either sex affected by CHF NYHA class I-III, secondary to ischemic or idiopathic di-lated cardiomyopathy;
- age range 18-85 years;
- stable and optimal medical therapy for at least three months prior to randomization, including ACE inhibitors or AT1 antagonists and beta-blockers (unless untolerated);
- LV ejection fraction 40% or less and LV end-diastolic dimension 55 mm or more;
- GH deficiency diagnosed with GHRH + arginine provocative test;
Key exclusion criteria (5 listed)
- inability to perform a bicycle exercise test;
- poorly controlled diabetes mellitus (HbA1c >8.5) and/or active proliferative or severe non-proliferative diabetic retinopathy;
- active and/or history of malignancy;
- unstable angina or recent myocardial infarction (less than six months);
- severe liver or kidney disease (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 |
|---|---|---|
| Human growth hormoneAdministration of growth hormone | Drug | GHD |
| PlaceboAdministration of placebo | Other | Placebo |
Primary outcome
Change of peak oxygen consumption (peak VO2)
Time frame: 1 year
According to previous observations, the investigators set a target increase of peak VO2 in the treated arm at 3 ml/kg/min at the end of the study
8 secondary outcomes
Number of Hospitalizations
Time frame: 1 year
End-systolic LV volumes
Time frame: 1 year
NT-proBNP levels
Time frame: 1 year
Quality of life score from the Minnesota Living with Heart Failure Questionnaire
Time frame: 1 year
Evaluation of Endothelial function (flow-mediated vasodilation)
Time frame: 1 year
Muscle strength (handgrip)
Time frame: 1 year
Evaluation of the Levels of Endothelial Progenitor Cells (EPCs)
Time frame: 1 year
Evaluation of the Levels of lymphocyte G protein-coupled receptor kinase (GRK)-2
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Derived from this study: PubMed 40047762Marra AM, D'Assante R, De Luca M, Arcopinto M, Gargiulo P, Valente V, Crisci G, Rainone C, Modestino M, Giardino F, Paolillo S, Cacciatore F, Saldamarco L, Bruzzese D, Scarpa D, Filardi PP, Esposito G, Sacca L, Bossone E, Salzano A, Cittadini A. Growth Hormone Replacement Therapy in Heart Failure With Reduced Ejection Fraction: A Randomized, Double-Blind, Placebo-Controlled Trial. JACC Heart Fail. 2025 Apr;13(4):602-614. doi: 10.1016/j.jchf.2024.11.017. Epub 2025 Mar 5.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Human growth hormone in people with Heart Failure and Growth Hormone Deficiency, run by Federico II University.
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 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: status not confirmed, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonio Cittadini, Full Professor of Medicine (+390817464375, cittadin@unina.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of peak oxygen consumption (peak VO2) (time frame: 1 year). 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 NCT03775993, which also lists 1 linked publication.
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 15 Feb 2019.