Treatment of the lOw IGF-1 Syndrome aSsociated With Chronic Heart fAilure: A Randomized, Placebo-Controlled, Double-Blind Study.

• Status: Suspended
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

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 CHF progression.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federico II University
• Treatments: Hormones

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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