Treatment of Growth Hormone Deficiency in patient with Chronic Heart Failure

Phase 1

• Conditions: Growth Hormone Deficiency associated with Chronic Heart Failure; MedDRA version: 20.0Level: PTClassification code 10056438Term: Growth hormone deficiencySystem Organ Class: 10014698 - Endocrine disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2016-004580-39-IT
• Lead Sponsor: AOU FEDERICO II

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-01
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 64

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 44

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: there is no evidence that GH replacement in adults increases the risk of de novo or recurrent malignancy. GH will not be initiated in patients with active neoplasm, either newly diagnosed or recurrent as well as in subjects with a history of cancer shorter than one year. Since growth hormone deficiency may be an early sign of the presence of a pituitary tumor (or, rarely, other brain tumors), the presence of such tumors will be ruled out prior to initiation of treatment. GH therapy will not be used in patients with any evidence of progression or recurrence of an underlying intracranial space-occupying lesion.
4)unstable angina or recent myocardial infarction (less than six months);
5)severe liver or kidney disease (serum creatinine levels >2.5 mg/dl)
6)patients with acute critical illnesses caused by complications of open heart or abdominal surgery, multiple accidental trauma, or acute respiratory failure.
7)active infection or sepsis.
8)any allergies to growth hormone, or other ingredients such as benzyl alcohol, sucrose, phosphoric acid, sodium hydroxide, or metacresol

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Aim of the current study is to assess the cardiovascular effects of GH replacement therapy in patients with coexisting GHD and CHF;Secondary Objective: 1.Hospitalizations for any cause requiring a ward stay longer than one night<br>2.End-systolic LV volumes<br>3.NT-proBNP levels <br>4.QoL scores<br>5.Endothelial function (flow-mediated vasodilation)<br>6.Muscle strength (handgrip)<br>7.Levels of Endothelial Progenitor Cells (EPCs) <br>8.Levels of lymphocyte G protein-coupled receptor kinase (GRK)-2 <br>;Primary end point(s): The objective of the study is to determine whether treatment of GHD improves peak oxygen con-sumption (peak VO2), a recognized surrogate end-point of CHF progression. According to previous observations, we set a target increase of peak VO2 in the treated arm at 3 ml/kg/min at the end of the study;Timepoint(s) of evaluation of this end point: 12 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary end-points include: <br>1.Hospitalizations<br>2.End-systolic LV volumes<br>3.NT-proBNP levels <br>4.QoL scores<br>5.Endothelial function (flow-mediated vasodilation)<br>6.Muscle strength (handgrip)<br>7.Levels of Endothelial Progenitor Cells (EPCs)<br>8.Levels of lymphocyte G protein-coupled receptor kinase (GRK)-2 <br>;Timepoint(s) of evaluation of this end point: 12 Months