Treatment of the lOw IGF-1 Syndrome aSsociated With Chronic Heart fAilure: A Randomized, Placebo-Controlled, Double-Blind Study. (TOSCA2)
Primary Purpose
Chronic Heart Failure
Status
Suspended
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Growth Hormone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Heart Failure
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
Sites / Locations
- Antonio Cittadini
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
GH replacement therapy
Placebo
Arm Description
Outcomes
Primary Outcome Measures
increase of peak VO2 consumption by at least 2.5 ml/kg/min during maximal physical exercise test.
Secondary Outcome Measures
Full Information
NCT ID
NCT01235273
First Posted
November 4, 2010
Last Updated
February 18, 2014
Sponsor
Federico II University
1. Study Identification
Unique Protocol Identification Number
NCT01235273
Brief Title
Treatment of the lOw IGF-1 Syndrome aSsociated With Chronic Heart fAilure: A Randomized, Placebo-Controlled, Double-Blind Study.
Acronym
TOSCA2
Official Title
Phase 2 Study of Growth Hormone Administration in Patients With Chronic Heart Failure and Low IGF-1 Levels
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Suspended
Why Stopped
insufficient enrollment
Study Start Date
January 2011 (undefined)
Primary Completion Date
February 2014 (Anticipated)
Study Completion Date
February 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
GH replacement therapy
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Growth Hormone
Intervention Description
growth hormone administration
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
standard placebo
Primary Outcome Measure Information:
Title
increase of peak VO2 consumption by at least 2.5 ml/kg/min during maximal physical exercise test.
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Antonio Cittadini
City
Napoli
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Treatment of the lOw IGF-1 Syndrome aSsociated With Chronic Heart fAilure: A Randomized, Placebo-Controlled, Double-Blind Study.
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