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Search / Trial NCT03775993

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

Growth Hormone Placebo Exercise Capacity Vascular Reactivity Lv Function Prognosis

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.

Locations

Patients applied

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Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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