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

Phase 2

Suspended

• Conditions: Chronic Heart Failure
• Interventions: Other: Placebo; Drug: Growth Hormone

• Registration Number: NCT01235273
• Lead Sponsor: Federico II University

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 CHF progression.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-04
• Study First Submitted QC: 2010-11-04
• Study First Posted: 2010-11-05
• Study Start: 2011-01
• Status Verified: 2014-02
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Last Update Submitted: 2014-02-18
• Last Update Posted: 2014-02-20

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
GH replacement therapy	Growth Hormone	-

Primary Outcome Measures

Name	Time	Method
increase of peak VO2 consumption by at least 2.5 ml/kg/min during maximal physical exercise test.	9 months

Trial Locations

Locations (1)

Antonio Cittadini; 🇮🇹 Napoli, Italy