Treatment of GHD Associated With CHF

NCT ID: NCT03775993

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2022-03-01

Brief Summary

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.

Conditions

Heart Failure; Growth Hormone Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

GHD

Group Type: ACTIVE_COMPARATOR

Human growth hormone

Intervention Type: DRUG

Administration of growth hormone

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Administration of placebo

Interventions

Human growth hormone

Administration of growth hormone

Intervention Type: DRUG

Placebo

Administration of placebo

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. patients of either sex affected by CHF NYHA class I-III, secondary to ischemic or idiopathic di-lated cardiomyopathy;

2. age range 18-85 years;

3. stable and optimal medical therapy for at least three months prior to randomization, including ACE inhibitors or AT1 antagonists and beta-blockers (unless untolerated);

4. LV ejection fraction 40% or less and LV end-diastolic dimension 55 mm or more;

5. GH deficiency diagnosed with GHRH + arginine provocative test;

6. signed informed consent.

Exclusion Criteria

1. inability to perform a bicycle exercise test;

2. poorly controlled diabetes mellitus (HbA1c >8.5) and/or active proliferative or severe non-proliferative diabetic retinopathy;

3. active and/or history of malignancy;

4. unstable angina or recent myocardial infarction (less than six months);

5. severe liver or kidney disease (serum creatinine levels >2.5 mg/dl

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Antonio Cittadini

Full Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Antonio Cittadini, Full Professor of Medicine

Role: CONTACT

cittadin@unina.it

+390817464375

References

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.

Reference Type: DERIVED

PMID: 40047762 (View on PubMed)

Other Identifiers

2016-004580-39

Identifier Type: -

Identifier Source: org_study_id