Growth Hormone Treatment in Patients With Ischemic Heart Failure and Circulating Levels of NT-proBNP
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 主要终点
- Change in left ventricular endsystolic volume
研究概览
简要总结
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).
详细描述
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 month study, consisting of a 9 month double-blind, placebo-controlled randomised growth hormone treatment phase followed by a 3 month growth hormone treatment-free period.
STUDY PHASE: III
COORDINATING CENTRE:
Endocrine Cardiac Unit (ECU) Sahlgrenska University Hospital, Sahlgrenska S-413 45 Göteborg Sweden
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
All care providers and patients were masked with respect to the study drug during the study
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Growth hormon group
A 12 month study, consisting of a 9 months growth hormone treatment phase followed by a 3 month growth hormone treatment-free period.
干预措施: Somatropin (Drug)
Control group
A 12 month study, consisting of a 9 month placebo treatment phase followed by a 3 month treatment-free period.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in left ventricular endsystolic volume
时间窗: 9 months
Measured by CMR
次要结局
- Change in left ventricular ejection fraction(9 months)
- Change in enddiastolic volume(9 months)
- Change in left ventricular mass(9 months)