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Completed

NCT Number: NCT01576861

Long-Term Efficacy and Safety of Growth Hormone Replacement Therapy in Chronic Heart Failure

After the encouraging results of 6 months of Growth Hormone Replacement Therapy in Patients With Chronic Heart Failure and Coexisting Growth Hormone Deficiency (NCT00591760) the investigators wanted to collect data about the long-term efficacy and safety of this kind of therapy.

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Key information

Conditions

Growth Hormone Deficiency Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Chronic Heart Failure Dwarfism Dwarfism, Pituitary Endocrine System Diseases Hypopituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Internal Medicine, Cardiovascular and Immunological Sciences

Naples, Campania, 80131, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chronic Heart Failure New York Heart Association functional class II to IV, secondary to ischemic or idiopathic cardiomyopathy
  • Age range 18-80 years
  • Stable medication for at least one month including beta-blockers that had to be started at least 5 months before entering the study
  • Left Ventricular ejection fraction 40% or less
  • Growth Hormone Deficiency (defined as a peak GH response to intravenous stimulation with GHRH + Arginine < 9 ng/ml)
  • Written Informed consent

Exclusion criteria

  • Acute proliferative or severe non-proliferative diabetic retinopathy
  • Active malignancy
  • Evidence of progression or recurrence of an underlying intracranial tumor
  • Unstable Angina or recent myocardial infarction
  • Serum Creatinine levels > 2.5 mg/dl
  • Severe liver disease (Child-Pugh B-C)

Treatment and study plan

Somatotropin

Drug

Subcutaneous Somatotropin (recombinant Human Growth Hormone) 0,012 mg/kg every second day

Primary outcomes

  1. Peak Oxygen Consumption

    Time frame: after 48 months

  2. Side effects

    Time frame: Any side effects recorded after 6,24 and 48 months

Secondary outcomes

  1. Left Ventricular Ejection Fraction

    Time frame: after 48 months

  2. Left Ventricular End-Systolic Volume

    Time frame: after 48 months

  3. Left Ventricular End-Diastolic Volume

    Time frame: after 48 months

  4. Quality of Life

    Time frame: after 48 months

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Apr 13, 2012
Registry last updated
Oct 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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