NCT00670111终止不适用
Restoration of Chronotropic Competence in Heart Failure Patients With Normal Ejection Fraction
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 32
- 试验地点
- 10
- 主要终点
- Peak Volume of Oxygen Uptake (Peak VO2) - Rate Adaptive Pacing (RAP) On at One Month vs. Rate Adaptive Pacing (RAP) Off at One Month.
研究概览
简要总结
This study will look at how pacing your heart may assist your daily activities and how you are feeling.
详细描述
RESET is a multicenter trial that will assess the effect of pacing in heart failure patients with a normal ejection fraction (or diastolic heart failure). The purpose of the RESET study is to evaluate the effect of pacing on exercise capacity and quality of life in this heart failure population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients who are in sinus rhythm
- •Patients who are on stable medical therapy
- •Patients who exhibit signs and symptoms of heart failure, New York Heart Association (NYHA) Class II or III
- •Patients who have experienced a hospitalization for decompensated heart failure; treatment for pulmonary congestion or volume overload; chronic treatment with a loop diuretic; or a brain natriuretic peptide (BNP) > 125 ng/l.
- •Left ventricular ejection fraction (LVEF) ≥ 50%
排除标准
- •Patients with persistent atrial fibrillation or atrial flutter
- •Patients who are in complete heart block
- •Patients who have experienced a recent myocardial infarction (MI) or have unstable angina or require cardiac surgery or other procedures
- •Patients who have severe heart valve disease or valve replacement
- •Patients with a contraindication for a pacemaker system
- •Patients who have a neuromuscular, orthopedic or other non-cardiac condition that prevents patient from exercise testing
- •Patients who have infiltrative or hypertrophic cardiomyopathy
- •Patients who have known severe pulmonary disease
- •Patients with uncontrolled diabetes or blood pressure (systolic blood pressure (SBP) > 160 mmHg or diastolic blood pressure (DBP) > 95 mmHg)
结局指标
主要结局
Peak Volume of Oxygen Uptake (Peak VO2) - Rate Adaptive Pacing (RAP) On at One Month vs. Rate Adaptive Pacing (RAP) Off at One Month.
时间窗: 1 month post implant
Randomized therapy order cross-over comparison at 1 month post-implant. Each patient evaluated for endpoint with and without RAP therapy at this time.
次要结局
- Peak Volume of Oxygen Uptake (Peak VO2) - Rate Adaptive Pacing (RAP) On at Six Months vs. Rate Adaptive Pacing (RAP) Off at One Month.(6 months post implant)
研究者
研究点 (10)
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