Growth Hormone Deficiency in Chronic Heart Failure: A Preliminary Trial

NCT00591760 | Completed Phase 2 Results

• 1 other identifier: GH replacement in CHF
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Heart Failure; Growth Hormone Deficiency; Ischemic Heart Disease

Keywords

Heart Failure; Growth Hormone; Anabolism; Anabolic Deficiency; Hormone replacement

Outcome Measures

Primary Outcomes (1)

• Peak VO2

  changes in peak VO2

  6 months

Study Arms (2)

GH

EXPERIMENTAL

Patients will receive 6 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

Placebo

NO INTERVENTION

PLacebo will be admistred with the same devices of GH, also on top of Optimal CHF treatment

Interventions

Somatotropin DRUG

Subcutaneous Somatotropin (recombinant human Growth Hormone) 0.012 mg/kg every second day for 6 months

Also known as: rhGH, Saizen, NutropinAq

GH

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Federico II University: lead

MeSH Terms

Conditions

Heart Failure; Dwarfism, Pituitary; Myocardial Ischemia

Interventions

Growth Hormone; Human Growth Hormone

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; 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; Vascular Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Prof. Antonio Cittadini
• Organization: Federico II University

antonio.cittadini@unina.it

0039(0)817464375

Study Officials

• Antonio Cittadini, MD

  Federico II University - Naples

  PRINCIPAL INVESTIGATOR

• Luigi Saccà, MD

  Federico II University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: January 11, 2008
• Study Start: December 1, 2004
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: November 19, 2012
• Results First Posted: November 19, 2012

Record last verified: 2009-03