Phase 2 N=56 Randomized Single-blind Treatment

Growth Hormone Deficiency in Chronic Heart Failure: A Preliminary Trial

Heart Failure · Growth Hormone Deficiency · Ischemic Heart Disease

Bottom Line

View on ClinicalTrials.gov: NCT00591760 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Nov 2012

Primary outcome: Primary: Peak VO2 — 14.5; 12.9 ml/kg/min

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Somatotropin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Federico II University
Primary completion: Nov 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Peak VO2	14.5; 12.9	—

Summary

The aim of this study is to investigate the potential benefits of the correction of growth hormone (GH) deficiency with GH replacement therapy in patients with chronic heart failure due to left ventricular systolic dysfunction.

Eligibility Criteria

Inclusion Criteria

Heart Failure in ew York Heart Association functional class II to IV
Left ventricular end diastolic diameter > 60 mm
Left ventricular ejection fraction < 40%
Growth Hormone Deficiency (defined as a peak GH response to intravenous stimulation with GHRH + Arginine < 9 ng/dl)
Age 18-80 years
Clinical stability, guideline-oriented maximal pharmacological therapy
Informed consent

Exclusion Criteria

Active Myocarditis
Hypertrophic Cardiomyopathy
Active endocarditis
Active malignancy
End stage renal disease
Severe liver disease (Child B-C)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00591760). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.