Growth Hormone in Ischemic Heart Failure

• Status: Completed
• Trial end date: 2012-02-25
• Target enrollment: 0
• Participant gender: All

Summary

In a double-blind, placebo-controlled trial, we randomly assigned 37 patients (mean age 66 years; 95% male) with ischemic heart failure (HF) (ejection fraction (EF) < 40%) to a 9-month treatment with either recombinant human GH (1.4 mg every other day) or placebo, with subsequent 3-month treatment-free follow-up. The primary outcome was change in left ventricular (LV) end-systolic volume measured by cardiac magnetic resonance (CMR). Secondary outcomes comprised changes in cardiac structure and EF. Prespecified tertiary outcomes included changes in New York Heat Association (NYHA) functional class and quality of life (QoL), as well as levels of insulin-like growth factor-1 (IGF-1) and N-terminal pro-brain natriuretic peptide (NT-proBNP).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Göteborg University

Criteria

Inclusion Criteria:

• Ejection fraction at rest less than 40% at the screening visit as measured by echocardiography and a left ventricular enddiastolic diameter > 32 mm/m2

• Stable, optimised therapy for heart failure for at least 4 weeks prior to randomisation including Angiotensin converting enzyme inhibitors, or if not tolerated, angiotensin II blockers and/or digitalis. If tolerated patients should receive beta-blockers for heart failure provided they have had a stable dose for at least 3 months prior to randomisation. The dose of diuretics may vary within a given dose-range considered normal for that patient as determined by the investigator.

• Written informed consent obtained

Exclusion Criteria:

• Uncontrolled hypertension, treated or not treated with a diastolic blood pressure >105 mm Hg

• Haemodynamic clinically significant primary valvular disease or significant congenital heart disease

• Hypertrophic or idiopathic dilated cardiomyopathy

• Acute pericarditis/myocarditis

• Echocardiography findings such as mobile thrombus, significant pericardial effusion and significant left ventricular aneurysm

• Symptomatic or sustained ventricular arrhythmias within the last 3 months not adequately treated with antiarrhythmic drugs or internal cardiovertor defibrillator (ICD)

• Unstable angina pectoris, or myocardial infarction within last 3 months

• percutaneous coronary intervention performed within 6 months prior to randomization

• Planned percutaneous coronary intervention, heart transplantation, other cardiac surgery or other major surgery

• Atrial fibrillation, if a frequency > 100/min or a large frequency variation, according to clinical judgment

• Diabetes mellitus, insulin treated

• Severe liver disease (alanine aminotransferase and/or alanine aminotransferase three times upper limit of normal range laboratory values)

• Severely reduced renal function (S-Creatinine above 250 micromol/l) or suspected significant renal artery stenosis

• Uncontrolled endocrine disorders

• Ongoing treatment with calcium antagonist

• Pregnancy or lactation or females of childbearing potential taking inadequate measures to prevent pregnancy

• History of or ongoing malignant disease

• Previous treatment with growth hormone

• Patients in a catabolic state

• Known drug and/or alcohol abuse

• 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