Growth Hormone Deficiency in Chronic Heart Failure: A Preliminary Trial
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|ClinicalTrials.gov Identifier: NCT00591760|
Recruitment Status : Completed
First Posted : January 11, 2008
Results First Posted : November 19, 2012
Last Update Posted : November 19, 2012
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure Growth Hormone Deficiency Ischemic Heart Disease||Drug: Somatotropin||Phase 2|
To date, a wide range of alterations in the GH/IGF-1 axis have been described 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 Unpublished experience of our group support the concept that a considerable amount of CHF-patients have a coexisting Growth Hormone Deficiency (GHD), defined by current guidelines(GH stimulation test).
Our study hypothesis is that correction of GH deficiency in patients with chronic heart failure may exert a beneficial effect on their cardiac function and remodeling, performance status and quality-of-life.
Since this was a preliminary study, no sample size calculation was performed; treatment effects from 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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Correction of Growth Hormone Deficiency in Patients With Chronic Heart Failure: a Randomized, Controlled, Single-blind Study|
|Study Start Date :||December 2004|
|Actual Primary Completion Date :||November 2007|
|Actual Study Completion Date :||November 2007|
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
Subcutaneous Somatotropin (recombinant human Growth Hormone) 0.012 mg/kg every second day for 6 months
No Intervention: Placebo
PLacebo will be admistred with the same devices of GH, also on top of Optimal CHF treatment
- Peak VO2 [ Time Frame: 6 months ]changes in peak VO2
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00591760
|Principal Investigator:||Antonio Cittadini, MD||Federico II University - Naples|
|Study Chair:||Luigi Saccà, MD||Federico II University|