Status:
COMPLETED
Growth Hormone in Ischemic Heart Failure
Lead Sponsor:
Göteborg University
Conditions:
Heart Failure, Systolic
Ischemic Heart Disease Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Detailed Description
TITLE: GROWTH HORMONE IN HEART FAILURE Addition of recombinant human growth hormone to standard heart failure therapy in patients with congestive heart failure due to ischaemic heart disease. A 12 mo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 28 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 25 2012
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT04420481
Start Date
April 28 2004
End Date
February 25 2012
Last Update
June 9 2020
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