Treatment of the low IGF-1 syndrome associated with Chronic Heart Failure: A Randomized, Placebo-Controlled, Double-Blind Study
- Conditions
- ow serum IGF-I and GH deficiency in patients with congestive heart failureTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2009-017011-16-SE
- Lead Sponsor
- niversity Federico II
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
•Patients of either sex affected by CHF NYHA class II-III, secondary to ischemic or idiopathic dilated cardiomyopathy
•Age range 30-80 years
•Stable medications for at least two months prior to randomization, including ACE inhibitors or AT1 antagonists and beta-blockers (unless untolerated).
•LV ejection fraction 40% or less
•Peak VO2 consumption during a CPET = 16 ml/kg/min.
•LV end-diastolic dimension 55 mm or more
•Low IGF-1 levels and a satisfactory response to an IGF-1 generation test (see below)
•Positive result after GH-provocation test (PD-GHRH; cut-off GH levels defined as 18.3, 9.0, and 5.0 mg/l for normal weight, overweight and obese subjects respectively)
•Informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 84
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 84
•Haemodynamic clinically significant primary valvular disease or significant congenital heart disease
•Acute pericarditis/myocarditis
•Inability to perform a bicycle exercise test
•Poorly controlled diabetes mellitus (HbA1c >8.5)
•Active proliferative or severe non-proliferative diabetic retinopathy
•Active and/or history of malignancy
•Evidence of progression or recurrence of an underlying intracranial tumor
•Unstable angina or recent myocardial infarction (less than 5 months)
•Severe liver disease
•Serum creatinine levels >2.5 mg/dl
•Inability to cooperate or administer the study drug
•Patients participating in any other clinical study, within 30 days prior to screening visit and/or during this particular study period
•With regard to inclusion criterion no. 7, an IGF-1 level will be considered low if below the 25th percentile of a sex and age matched population (33-35). The following cut-off values will be used: 130 ng/ml (age 30-39 y); 115 ng/ml (age 40-49 y); 105 ng/ml (age 50-59 y); 95 ng/ml (age 60-69 y); 85 ng/ml (age 70-80 y).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of the study is to determine whether treatment of the low IGF-1 syndrome in patients with CHF is able to modify some functional parameters, recognized as valid surrogate end-points of CHF progression;Secondary Objective: ;Primary end point(s): Increase of peak VO2 consumption by at least 2.5 ml/kg/min during maximal physical exercise test.<br>;Timepoint(s) of evaluation of this end point: Baseline and after 9 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): •LV end-systolic and end-diastolic volumes, determined by echocardiography<br>•LV performance indices (ejection fraction, strain, strain rate)<br>•LV diastolic filling<br>•Exercise duration<br>•Anaerobic threshold<br>•Ventilatory efficiency (VE/VCO2 slope)<br>•Flow mediated dilation of the brachial artery<br>•Quality of life<br>•Anxiety and depression scores <br>•Serum levels of NT-proBNP, inflammatory cytokines, hsCRP, testosterone and DHEA, thyroid hormones, and insulin-resistance index.<br>•GH pituitary generation capacity following a stimulation test<br>;Timepoint(s) of evaluation of this end point: Baseline and 9 months