Status:
UNKNOWN
Treatment of GHD Associated With CHF
Lead Sponsor:
Federico II University
Conditions:
Heart Failure
Growth Hormone Deficiency
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
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 m...
Eligibility Criteria
Inclusion
- patients of either sex affected by CHF NYHA class I-III, secondary to ischemic or idiopathic di-lated cardiomyopathy;
- age range 18-85 years;
- stable and optimal medical therapy for at least three months prior to randomization, including ACE inhibitors or AT1 antagonists and beta-blockers (unless untolerated);
- LV ejection fraction 40% or less and LV end-diastolic dimension 55 mm or more;
- GH deficiency diagnosed with GHRH + arginine provocative test;
- signed informed consent.
Exclusion
- inability to perform a bicycle exercise test;
- poorly controlled diabetes mellitus (HbA1c \>8.5) and/or active proliferative or severe non-proliferative diabetic retinopathy;
- active and/or history of malignancy;
- unstable angina or recent myocardial infarction (less than six months);
- severe liver or kidney disease (serum creatinine levels \>2.5 mg/dl
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2022
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT03775993
Start Date
March 1 2019
End Date
March 1 2022
Last Update
February 15 2019
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