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

This study has suspended participant recruitment.
(insufficient enrollment)
Sponsor:
Information provided by (Responsible Party):
Antonio Cittadini, Federico II University
ClinicalTrials.gov Identifier:
NCT01235273
First received: November 4, 2010
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Chronic Heart Failure
Drug: Growth Hormone
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Growth Hormone Administration in Patients With Chronic Heart Failure and Low IGF-1 Levels

Resource links provided by NLM:


Further study details as provided by Federico II University:

Primary Outcome Measures:
  • increase of peak VO2 consumption by at least 2.5 ml/kg/min during maximal physical exercise test. [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GH replacement therapy Drug: Growth Hormone
growth hormone administration
Placebo Comparator: Placebo Other: Placebo
standard placebo

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01235273

Locations
Italy
Antonio Cittadini
Napoli, Italy
Sponsors and Collaborators
Federico II University
  More Information

No publications provided

Responsible Party: Antonio Cittadini, Associate Professor of Internal Medicine, Federico II University
ClinicalTrials.gov Identifier: NCT01235273     History of Changes
Other Study ID Numbers: TOSCAproject
Study First Received: November 4, 2010
Last Updated: February 18, 2014
Health Authority: European Union: European Medicines Agency

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014