Treatment of GHD Associated With CHF

• Status: Not yet recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federico II University
• Treatments: Hormones

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