Treatment of GHD Associated With CHF
Launched by FEDERICO II UNIVERSITY · Dec 12, 2018
Trial Information
Current as of May 21, 2025
Unknown status
Keywords
ClinConnect Summary
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 re...
Gender
ALL
Eligibility 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
About Federico Ii University
Federico II University, located in Naples, Italy, is a prestigious academic institution with a strong emphasis on advanced research and clinical innovation. As a clinical trial sponsor, the university is committed to fostering the development of novel therapeutic interventions and enhancing patient care through rigorous scientific inquiry. With a multidisciplinary approach, Federico II University collaborates with healthcare professionals, researchers, and industry partners to conduct high-quality clinical trials that adhere to ethical standards and regulatory requirements. Its dedication to improving health outcomes is reflected in its robust research programs and commitment to translating scientific findings into clinical practice.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials