ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01235273
Recruitment Status : Suspended (insufficient enrollment)
First Posted : November 5, 2010
Last Update Posted : February 20, 2014
Sponsor:
Information provided by (Responsible Party):
Antonio Cittadini, 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.

Condition or disease Intervention/treatment Phase
Chronic Heart Failure Drug: Growth Hormone Other: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : January 2011
Estimated Primary Completion Date : February 2014
Estimated Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: GH replacement therapy Drug: Growth Hormone
growth hormone administration
Placebo Comparator: Placebo Other: Placebo
standard placebo



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


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01235273


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

Responsible Party: Antonio Cittadini, Associate Professor of Internal Medicine, Federico II University
ClinicalTrials.gov Identifier: NCT01235273     History of Changes
Other Study ID Numbers: TOSCAproject
First Posted: November 5, 2010    Key Record Dates
Last Update Posted: February 20, 2014
Last Verified: February 2014

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