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

NCT ID: NCT01235273

Last Updated: 2014-02-20

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2014-02-28

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.

Conditions

Chronic Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

GH replacement therapy

Group Type: EXPERIMENTAL

Growth Hormone

Intervention Type: DRUG

growth hormone administration

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

standard placebo

Interventions

Growth Hormone

growth hormone administration

Intervention Type: DRUG

Placebo

standard placebo

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Antonio Cittadini

Associate Professor of Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Antonio Cittadini

Napoli, , Italy

Countries

Italy

Other Identifiers

TOSCAproject

Identifier Type: -

Identifier Source: org_study_id