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

Chronic Heart Failure Clinical Trial

— TOSCA2  

Official title:

Phase 2 Study of Growth Hormone Administration in Patients With Chronic Heart Failure and Low IGF-1 Levels

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01235273
• Other study ID #: TOSCAproject
• Status: Suspended
• Phase: Phase 2
• First received: November 4, 2010
• Last updated: February 18, 2014
• Start date: January 2011
• Est. completion date: February 2014

Study information

• Verified date: February 2014
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 100
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Drug:
• Growth Hormone
growth hormone administration

Other:
• Placebo
standard placebo

Locations

Country	Name	City	State
Italy	Antonio Cittadini	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	increase of peak VO2 consumption by at least 2.5 ml/kg/min during maximal physical exercise test.		9 months	Yes