Treatment of GHD Associated With CHF

Heart Failure Clinical Trial

Official title:

Treatment of Growth Hormone Deficiency Associated With Chronic Heart Failure: A Randomized, Double-Blind, Placebo-Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03775993
• Other study ID #: 2016-004580-39
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: March 1, 2019
• Est. completion date: March 1, 2022

Study information

• Verified date: February 2019
• Source: Federico II University
• Contact: Antonio Cittadini, Full Professor of Medicine
• Phone: +390817464375
• Email: cittadin[@]unina.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 64
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Dwarfism, Pituitary
• Endocrine System Diseases
• Growth Hormone Deficiency
• Heart Failure

Intervention

Drug:
• Human growth hormone
Administration of growth hormone

Other:
• Placebo
Administration of placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 year
Secondary	Number of Hospitalizations		1 year
Secondary	End-systolic LV volumes		1 year
Secondary	NT-proBNP levels		1 year
Secondary	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.	1 year
Secondary	Evaluation of Endothelial function (flow-mediated vasodilation)		1 year
Secondary	Muscle strength (handgrip)		1 year
Secondary	Evaluation of the Levels of Endothelial Progenitor Cells (EPCs)		1 year
Secondary	Evaluation of the Levels of lymphocyte G protein-coupled receptor kinase (GRK)-2		1 year