Status:
SUSPENDED
Treatment of the lOw IGF-1 Syndrome aSsociated With Chronic Heart fAilure: A Randomized, Placebo-Controlled, Double-Blind Study.
Lead Sponsor:
Federico II University
Conditions:
Chronic Heart Failure
Eligibility:
All Genders
30-80 years
Phase:
PHASE2
Brief Summary
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 CH...
Eligibility Criteria
Inclusion
- 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
- informed consent
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2014
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01235273
Start Date
January 1 2011
End Date
February 1 2014
Last Update
February 20 2014
Active Locations (1)
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1
Antonio Cittadini
Napoli, Italy