Study for the Treatment of Heart Failure with Preserved Heart Function related to high blood pressure using Right upper chamber Pacing controlled by the PressurePaceTM System.
- Conditions
- Diastolic (congestive) heart failure,
- Registration Number
- CTRI/2023/08/056316
- Lead Sponsor
- BaroPace Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 16
- 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 6.
- 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 8.
- 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.
- 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 5.
- Indications for emergency surgery at time of screening or planned surgery before the 49-day follow-up 6.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy Evaluation At Screening Day, Day 7, Day 28, Day 49 | From screening to end of study- Day 49 Modified Bruce Protocol treadmill total exercise time At Screening Day, Day 7, Day 28, Day 49 | From screening to end of study- Day 49 Safety Evaluation At Screening Day, Day 7, Day 28, Day 49 | From screening to end of study- Day 49 Absence of Related Serious Adverse events At Screening Day, Day 7, Day 28, Day 49 | From screening to end of study- Day 49
- Secondary Outcome Measures
Name Time Method Efficacy Evaluation NYHA class
Trial Locations
- Locations (4)
Dr. C.M. Chopra Hospital & Heart Care Centre
🇮🇳Jaipur, RAJASTHAN, India
LPS Institute of Cardiology & Cardiac Surgery, GSVM Medical College
🇮🇳Nagar, UTTAR PRADESH, India
Maharaja Agrasen Superspeciality Hospital
🇮🇳Jaipur, RAJASTHAN, India
National Institute of Medical Science and Research
🇮🇳Jaipur, RAJASTHAN, India
Dr. C.M. Chopra Hospital & Heart Care Centre🇮🇳Jaipur, RAJASTHAN, IndiaDr Rohit ChopraPrincipal investigator8867137737Drrc2306@gmail.com