A Randomized, Blinded, Placebo-Controlled Six Month Treatment Trial of Aliskiren to Improve Exercise Tolerance in Older Patients With Heart Failure and Normal Ejection Fraction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Exercise Treadmill Time
研究概览
简要总结
The primary objective of this study is to determine whether treatment with aliskiren (300 mg) compared to placebo will improve treadmill exercise time in older (age ≥ 55 years) patients with heart failure and normal ejection fraction (HFNEF).
详细描述
Heart Failure with Normal Ejection Fraction (HFNEF) is the most common form of heart failure, particularly in older persons. However, the optimal therapy for this disorder has not been defined. The primary chronic symptom in HFNEF is exercise intolerance, manifested by shortness of breath and fatigue with exercise. This is the major determinant of quality of life, can be measured objectively and reproducibly and is modifiable.
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)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 55 years of age
- •Symptomatic HFNEF of at least 1 month duration.
- •Reduced early diastolic mitral annular velocity by tissue Doppler
- •Left ventricular ejection fraction (LVEF ≥ 0.50)
- •Baseline exercise intolerance
- •Patients who are able to provide written informed consent
- •Stable medical therapy for 30 days prior to screening
排除标准
- •Seated blood pressure ≥ 160/90 mmHg at Visit 1 (screening)
- •Clinically significant pulmonary disease
- •Known history of documented EF < 0.45 at any time
- •Clinically unstable heart failure, medication changes for worsening heart failure symptoms within the past 4 weeks
- •Severe anemia (Hgb <10 mg/dL)
- •Clinical evidence of uncontrolled hypo or hyperthyroidism
- •Clinically significant valvular heart disease
- •Surgical correction of valvular heart disease within the last year
- •Known familial hypertrophic cardiomyopathy or hypertrophic obstructive cardiomyopathy
- •Known restrictive cardiomyopathy or systemic illness known to be associated with infiltrative myocardial disease (e.g. amyloidosis, sarcoidosis, hemachromatosis)
- •Pericardial restriction or hemodynamically significant pericardial effusion
- •Cor pulmonal or other causes of right heart failure not related to LV dysfunction
- •Extreme obesity (weight > 325 pounds)
- •Acute coronary syndrome within past 3 months
- •Coronary artery revascularization within past 3 months
- •Peripheral artery revascularization within past 3 months
- •Acute cerebrovascular syndrome (stroke or TIA) within the past 3 months
- •Uncontrolled symptomatic brady- or tachyarrhythmia
- •Creatinine > 2.5 mg/dl at screening
- •Potassium > 5.2 meq/l at screening
- •Prior treatment with, hypersensitivity to, intolerance of or contra-indication to aliskiren
- •Current treatment with antidepressant medication in the MAO(Monoamine Oxidase) inhibitor or SSRI(Selective serotonin reuptake inhibitors) class
- •Current participation in another clinical trial
- •Current treatment with both an ACE(Angiotensin-converting enzyme) inhibitor and an angiotensin receptor antagonist.
- •Known significant bilateral renal artery stenosis
- •Serious non-cardiovascular disease severely limiting life expectancy
- •Previous major organ (e.g., lung, liver, heart, kidney) transplantation or on a transplant waiting list
- •Any condition that is likely to prevent the patient from complying with the requirements of the study or completing the study (e.g., history of poor compliance, alcohol or drug dependency, psychiatric illness, no permanent home)
- •Pregnant women, nursing women, and women of childbearing potential.
研究组 & 干预措施
Aliskiren
50 % of subjects participating in this trial will be on the active medication, Aliskiren 300mg qd, the other 50% will be on placebo.
干预措施: aliskiren (Drug)
Placebo
50% of subjects will be randomized to placebo.
干预措施: placebo (Drug)
结局指标
主要结局
Exercise Treadmill Time
时间窗: Baseline, 24 week visit
Treadmill exercise time to exhaustion on the modified naughton protocol. LS-mean is in effect, within-group means appropriately adjusted for the other effects in the model.
次要结局
未报告次要终点