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

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

Status

Suspended

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01235273

Acronym

TOSCA2

Enrollment

100

Registered

2010-11-05

Start date

2011-01-31

Completion date

2014-02-28

Last updated

2014-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Heart Failure

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.

Interventions

DRUGGrowth Hormone

growth hormone administration

OTHERPlacebo

standard placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026