Treatment of GHD Associated With CHF

Federico II University

Status and phase: Unknown; Phase 3

Conditions: Heart Failure; Growth Hormone Deficiency

Treatments: Other: Placebo; Drug: Human growth hormone

Study type: Interventional

Funder types: Other

Identifiers

NCT03775993

2016-004580-39

Details and patient eligibility

About

Aim of the current study is to assess the cardiovascular effects of GH replacement therapy in patients with coexisting GHD and CHF

Full 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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 2 patient groups, including a placebo group

GHD

Active Comparator group

Treatment:

Drug: Human growth hormone

Placebo

Placebo Comparator group

Treatment:

Other: Placebo