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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 19, 2014