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| Sponsor: | Federico II University |
|---|---|
| Information provided by: | Federico II University |
| ClinicalTrials.gov Identifier: | NCT00591760 |
Purpose
Aim of this study is to define the possible benefits of growth hormone supplementation, in patients with heart failure due to left ventricular systolic dysfunction and coexisting growth hormone deficiency.
| Condition | Intervention | Phase |
|---|---|---|
|
Heart Failure Growth Hormone Deficiency Ischemic Heart Disease |
Drug: Somatotropin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | Preliminary Study of Growth Hormone Replacement Therapy in Patients With Chronic Heart Failure and Coexisting Growth Hormone Deficiency |
| Enrollment: | 56 |
| Study Start Date: | December 2004 |
| Study Completion Date: | November 2007 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: GH
Patients will receive 12 months of substitutive somatotropin (growth hormone) therapy at a dose of 0,00415 mg/kg a day, added to their background optimized CHF therapy
|
Drug: Somatotropin
Subcutaneous Somatotropin (recombinant Human Growth Hormone) 0,00415 mg/kg a day everyday or every other day 12 months
|
|
No Intervention: Control
Optimal CHF treatment
|
A wide range of alterations in the GH/IGF-1 axis have been described to date in patients with chronic heart failure (CHF): reductions in GH levels, reductions in IGF-1 and a pattern of peripheral resistance to GH, in particular in patients with severe heart failure and cardiac cachexia. Unpublished experience of our group has led to the observation that a considerable amount of CHF-patients have a coexisting Growth Hormone Deficiency (GHD), as defined using current diagnostic criteria (GH stimulation test).
Our study hypothesis is that treatment of GH deficiency in patients with heart failure may exert a beneficial effect on their cardiac function and remodeling, performance status and quality-of-life estimators.
Since this was a preliminary study, no sample size calculation was applied, and changes were sought in left ventricular function (as assessed by cardiac MRI), cardiopulmonary exercise performance, clinical status, vascular reactivity, biochemistry and neurohumoral markers of disease (NT-proBNP).
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | Antonio Cittadini, Federico II University |
| ClinicalTrials.gov Identifier: | NCT00591760 History of Changes |
| Other Study ID Numbers: | GH replacement in HF |
| Study First Received: | December 20, 2007 |
| Last Updated: | October 14, 2008 |
| Health Authority: | Italy: Ethics Committee; Italy: Ministry of Health |
|
Heart Failure Growth Hormone Anabolism Anabolic Deficiency Hormone replacement |
|
Coronary Artery Disease Myocardial Ischemia Dwarfism, Pituitary Heart Diseases Heart Failure Endocrine System Diseases Coronary Disease Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular 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 Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
