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

NCT01576861 | Completed Phase 2

• 1 other identifier: Long-Term GH in CHF
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Growth Hormone Deficiency; Chronic Heart Failure

Outcome Measures

Primary Outcomes (2)

• Peak Oxygen Consumption

  after 48 months

• Side effects

  Any side effects recorded after 6,24 and 48 months

Secondary Outcomes (4)

• Left Ventricular Ejection Fraction

  after 48 months

• Left Ventricular End-Systolic Volume

  after 48 months

• Left Ventricular End-Diastolic Volume

  after 48 months

• Quality of Life

  after 48 months

Study Arms (2)

GH replacement

EXPERIMENTAL

Patients will receive 48 months of substitutive somatotropin (growth hormone) therapy at a dose of 0,012 mg/kg every second day, added to their background optimized CHF therapy

Drug: Somatotropin

Control CHF patients under optimized CHF therapy

NO INTERVENTION

Interventions

Somatotropin DRUG

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

GH replacement

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Department of Internal Medicine, Cardiovascular and Immunological Sciences

Napoli, Campania, 80131, Italy

Location

MeSH Terms

Conditions

Dwarfism, Pituitary

Interventions

Growth Hormone

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 19, 2012
• First Posted: April 13, 2012
• Study Start: January 1, 2007
• Primary Completion: March 1, 2011
• Study Completion: December 1, 2011
• Last Updated: October 18, 2012

Record last verified: 2012-10

Locations

IT (1)