Treatment of the low IGF-1 syndrome associated with Chronic Heart Failure: A Randomized, Placebo-Controlled, Double-Blind Study

• Register: EUCTR
• Last refreshed on: 18 September 2012
• Main ID: EUCTR2009-017011-16-SE
• Date of registration: 04/05/2011
• Prospective Registration: Yes
• Primary sponsor: University Federico II
• Public title: Treatment of the low IGF-1 syndrome associated with Chronic Heart Failure: A Randomized, Placebo-Controlled, Double-Blind Study
• Scientific title: Treatment of the low IGF-1 syndrome associated with Chronic Heart Failure: A Randomized, Placebo-Controlled, Double-Blind Study
• Date of first enrolment: 16/06/2011
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-017011-16
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Sweden

Key inclusion & exclusion 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 (see below)
• Positive result after GH-provocation test (PD-GHRH; cut-off GH levels defined as 18.3, 9.0, and 5.0 mg/l for normal weight, overweight and obese subjects respectively)
• Informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 84
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 84

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
• With regard to inclusion criterion no. 7, an IGF-1 level will be considered low if below the 25th percentile of a sex and age matched population (33-35). The following cut-off values will be used: 130 ng/ml (age 30-39 y); 115 ng/ml (age 40-49 y); 105 ng/ml (age 50-59 y); 95 ng/ml (age 60-69 y); 85 ng/ml (age 70-80 y).



Age minimum:
Age maximum:
Gender:
Female: no
Male: no

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Low serum IGF-I and GH deficiency in patients with congestive heart failure

Intervention(s)

Trade Name: Saizen
Product Name: Saizen
Pharmaceutical Form: Concentrate and solvent for injection

Primary Outcome(s)

Main Objective: 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

Secondary Objective:

Primary end point(s): Increase of peak VO2 consumption by at least 2.5 ml/kg/min during maximal physical exercise test.

Timepoint(s) of evaluation of this end point: Baseline and after 9 months

Secondary Outcome(s)

Secondary end point(s): • LV end-systolic and end-diastolic volumes, determined by echocardiography
• LV performance indices (ejection fraction, strain, strain rate)
• LV diastolic filling
• Exercise duration
• Anaerobic threshold
• Ventilatory efficiency (VE/VCO2 slope)
• Flow mediated dilation of the brachial artery
• Quality of life
• Anxiety and depression scores
• Serum levels of NT-proBNP, inflammatory cytokines, hsCRP, testosterone and DHEA, thyroid hormones, and insulin-resistance index.
• GH pituitary generation capacity following a stimulation test

Timepoint(s) of evaluation of this end point: Baseline and 9 months

Secondary ID(s)

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