Early Feasibility, Randomized Crossover and Double-Blind Design, Study for the Treatment of Heart Failure with preserved Ejection Fraction (HFpEF) associated with Hypertension Utilizing Right Atrial Pacing Regulated by the PressurePaceâ„¢ System (RelieveHFpEF-II)
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 16
- 试验地点
- 4
- 主要终点
- Efficacy Evaluation
研究概览
简要总结
This study is a prospective, double blind, self-controlled, randomized, cross-over study to evaluate the feasibility, efficacy, and safety of treating patients with Heart Failure with preserved Ejection Fraction (HFpEF) associated with hypertension using the PressurePaceâ„¢ system of Right Atrial Pacing regulated by blood pressure in subjects with dual chamber pacemakers.
The objective of this study is to show that blood pressure-controlled right atrial pacing improves exercise tolerance, improves heart failure symptoms, and improves hypertension control in subjects with HFpEF associated with hypertension compared to conventional bradycardia pacing alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 35.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Have a Pacetronix dual chamber pacemaker implanted for > 2 weeks that is more than 6 months from ERI (elective replacement indicator).
- •Ages: Adult subjects > 35 years and < 90 of age.
- •Have heart failure with preserved ejection fraction defined as ejection fraction > 45 percent.
- •Have hypertension (SBP >135 mmHg) within 30 days before the start of screening, despite at least one or more medication for the treatment of hypertension.
- •Screening average right atrial pacing < 50% and average intrinsic/pacing heart rate < 70 bpm over the previous clinical monitoring period of the pacemaker diagnostics of at least 14 days
- •Blood pressure of no less than 135 systolic and a diastolic blood pressure no less than 85 mm Hg at initial screening over 3 readings in 30 minutes in the sitting position, in the left arm.
- •Able to tolerate at least 3 minutes of a Modified Bruce Protocol Treadmill
- •Physically capable and willing to perform repeated 6-minute walk tests associated with the study, and a baseline distance of at least 225 meters.
- •Symptoms limiting the duration of the 6-minute walk test must be due to heart failure alone.
- •Willing and able to sign consent.
- •Stable medications for Hypertension for at least 4 weeks prior to screening.
排除标准
- •A resting SBP > 170 mmHg, or < 130 SBP at screening average over 3 readings in 30 minutes.
- •The readings will be taken with the blood pressure cuff on the subject’s left arm while seated after at least ten minutes of rest.
- •Consecutive readings will be taken at least 10 minutes apart.
- •A resting DBP > 120 mmHg, or < 80 at screening average over 3 measurements in 30 minutes.
- •Physical or psychological condition which would impair study participation.
- •End Stage Renal Disease on haemodialysis
- •Indications for emergency surgery at time of screening or planned surgery before the 49-day follow-up
- •Pregnant or breast-feeding.
- •Hospitalized in the prior six months for a heart attack, stroke, or TIA, or have a history of blood-pressure related syncope in last 6 months.
- •Have a pacemaker that is currently the subject of a manufacturer’s recall or regulatory advisory of malfunction.
- •Prone to atrial or ventricular arrhythmias with altered pacing.
- •Unstable from a cardiovascular standpoint, such as on-going chest pain, the diagnosis of heart failure with reduced EF, or who report being ill or otherwise uncomfortable, medically, or psychologically at the time of study.
- •Unable to interact and execute commands with the BaroPace modules during the screening phase.
- •Taking short-acting Nifedipine or Clonidine or taking ISA Beta Blockers; Acebutolol, Pindolol, Sectral or Visken.
结局指标
主要结局
Efficacy Evaluation
时间窗: At Screening Day, Day 7, Day 28, Day 49 | From screening to end of study- Day 49
Modified Bruce Protocol treadmill total exercise time
时间窗: At Screening Day, Day 7, Day 28, Day 49 | From screening to end of study- Day 49
Safety Evaluation
时间窗: At Screening Day, Day 7, Day 28, Day 49 | From screening to end of study- Day 49
Absence of Related Serious Adverse events
时间窗: At Screening Day, Day 7, Day 28, Day 49 | From screening to end of study- Day 49
次要结局
- Efficacy Evaluation(NYHA class)