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

NCT01235273 | Suspended Phase 2

• 1 other identifier: TOSCAproject
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Heart Failure

Outcome Measures

Primary Outcomes (1)

• increase of peak VO2 consumption by at least 2.5 ml/kg/min during maximal physical exercise test.

  9 months

Study Arms (2)

GH replacement therapy

EXPERIMENTAL

Drug: Growth Hormone

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Growth Hormone DRUG

growth hormone administration

GH replacement therapy

Placebo OTHER

standard placebo

Placebo

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Antonio Cittadini

Napoli, Italy

Location

MeSH Terms

Interventions

Growth Hormone

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine

Study Record Dates

• First Submitted: November 4, 2010
• First Posted: November 5, 2010
• Study Start: January 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: February 20, 2014

Record last verified: 2014-02

Locations

IT (1)