Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 105
- 试验地点
- 19
- 主要终点
- Characterize the effect of pacing therapies on health status, defined as change in the Minnesota Living with Heart Failure Questionnaire (MLHFQ) from baseline to 3, 6, and 9 months.
研究概览
简要总结
FIRE-HFpEF is a multi-center, prospective, randomized, single-blinded, clinical feasibility study. This study will enroll up to 105 subjects with heart failure with preserved ejection fraction in the United States. Data will be collected to evaluate whether pacing therapies can lead to improvements in exercise capacity and health status of subjects.
详细描述
After enrollment, baseline data will be collected, and subjects will then have a pacemaker implanted. After 6 weeks, subjects will have a follow up visit with a blood draw and a cardiac MRI. At this visit, subjects will be randomized 2:1 for pacing therapy or as a control (programmed into either a non-pacing mode or an exertional rate-adaptive pacing mode with no planned pacing at rest). After 3, 6 and 9 months after randomization, subjects will return for a follow up visit. At the 9-month visit therapy modifications will be made based on initial pacing randomization assignment: pacing therapy will be terminated in the original therapy group and enabled in the control group. After an additional 3-months of follow-up, subjects will return for their final visit, therapies will be disabled in all subjects and subjects will be exited. Echocardiographic, functional, and health status endpoints will be collected and analyzed to assess therapy efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Subjects and assessors of outcomes will be blinded to treatment assignment.
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
- •Diagnosis of Heart Failure, Left Ventricular Ejection Fraction (LVEF) ≥ 55% (this and other measurements must be made within the last year).
- •New York Heart Association (NYHA) Functional Class I-III
- •Stable on guideline-directed medical therapy (GDMT) heart failure medications as determined by the investigator, for at least 1 month, with the exception of loop diuretic therapy. GDMT should be in accordance with current American Heart Association (AHA)/American College of Cardiology (ACC)/Heart Failure Society of America (HFSA) Guidelines and include consideration of Sodium/glucose cotransporter-2 inhibitors (SGLT2i) therapy.
- •V End Diastolic Volume indexed to body surface area (BSA) ≤ 80 mL/m^
- •Concentric remodeling or concentric hypertrophy defined as at least one of the following criteria:
- •Left ventricular (LV) posterior or lateral wall thickness > 11mm
- •Relative wall thickness (RWT) > 0.42
- •Male and LV mass indexed to BSA ≥115 g/m2
- •Male and LV mass indexed to height ≥ 49.2 g/m2.7
- •Female and LV mass indexed to BSA ≥ 95 g/m2
- •Female and LV mass indexed to height ≥ 46.7 g/m2.7
排除标准
- •Unable or unwilling to undergo contrast MRI.
- •Class I indication for permanent pacing, except for symptomatic chronotropic incompetence
- •Current permanent or persistent Atrial fibrillation (A-fib)
- •Structural heart disease requiring intervention
- •Aortic valve replacement procedure less than 12 months prior to enrollment
- •Known pericardial constriction, genetic hypertrophic cardiomyopathy, or infiltrative cardiomyopathy
- •Severe aortic or mitral valve disease, defined as severe regurgitation or a valve area < 1cm^2
- •Exertional angina
- •Severe pulmonary disease including severe Chronic obstructive pulmonary disease (COPD) (i.e., requiring home oxygen, chronic nebulizer therapy, or chronic oral steroid therapy or hospitalized for pulmonary decompensation within 12 months)
- •Estimated glomerular filtration rate (eGFR) < 25 ml/min/1.73m^2 as calculated by the Modification in Diet in Renal Disease (MDRD) formula
- •Uncontrolled blood pressure, defined as systolic pressure outside the range of 100 to 160 mmHg despite anti-hypertensive medication.
研究组 & 干预措施
Pacemaker with multiple pacing therapies enabled
Device will be programmed for personalized lower rate pacing (PLR) and tachycardiac remodeling pacing (TRT).
干预措施: Pacemaker PLR + TRT ON (Device)
Pacemaker with no pacing therapies enabled
Device will be programmed to a non-pacing mode or an exertional rate-adaptive pacing mode with no planned pacing at rest.
干预措施: Pacemaker non-pacing mode or an exertional rate-adaptive pacing mode with no planned pacing at rest. (Device)
结局指标
主要结局
Characterize the effect of pacing therapies on health status, defined as change in the Minnesota Living with Heart Failure Questionnaire (MLHFQ) from baseline to 3, 6, and 9 months.
时间窗: Through study completion, projected for three years until last subject last 12-month visit.
The Minnesota Living with Heart Failure Questionnaire (MLHFQ) is a validated patient-oriented measure of the adverse effects of heart failure on a patient's life. Each of the 21 questions are scored on a 6-point Likert Scale (0 to 5), the total score could range from 0 to 105, with higher scores indicating more significant impairment in health-related quality of life.
Characterize the durability of cardiac remodeling changes and assess the safety and tolerability of TRT + PLR.
时间窗: Through study completion, projected for three years until last subject last 12-month visit.
characterize the effect of TRT + PLR on cardiac structure. LV mass, LVEDV, LVESV, and wall thickness which will be collected at baseline, 3-month, 6-month, 9-month, and 12-month visits.
时间窗: Through study completion, projected for three years until last subject last 12-month visit.
次要结局
未报告次要终点