Treatment of the lOw IGF-1 Syndrome aSsociated With Chronic Heart fAilure: A Randomized, Placebo-Controlled, Double-Blind Study. (TOSCA2)

Federico II University

Status and phase

Suspended

Phase 2

Conditions

Chronic Heart Failure

Treatments

Other: Placebo

Drug: Growth Hormone

Study type

Interventional

Funder types

Other

Identifiers

NCT01235273

TOSCAproject

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

30 to 80 years old

Volunteers

No Healthy Volunteers

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