Health Condition 1: I503- Diastolic (congestive) heart failure
Conditions
Interventions
Intervention1: BaroPacing treatment: Group 1 will use BaroPacing for the first 3 weeks (day 8 to day 28) and then switch to standard treatment for another 3 weeks (day 29 to day 49).
Control Intervent
Sponsors
BaroPace Inc.
JSS Medical Research Asia Pacific Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Have a Pacetronix dual chamber pacemaker implanted for > 2 weeks that is more than 6 months from ERI (elective replacement indicator). 2. Ages: Adult subjects > 35 years and 3. Have heart failure with preserved ejection fraction defined as ejection fraction > 45 percent. 4. 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. 5. Screening average right atrial pacing 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. 7. 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. 9. Willing and able to sign consent. 10. Stable medications for Hypertension for at least 4 weeks prior to screening.
Exclusion criteria
Exclusion criteria: 1. A resting SBP > 170 mmHg, or 2. A resting DBP > 120 mmHg, or 3. Physical or psychological condition which would impair study participation. 4. 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. 7. 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. 8. Have a pacemaker that is currently the subject of a manufacturer’s recall or regulatory advisory of malfunction. 9. Prone to atrial or ventricular arrhythmias with altered pacing. 10. 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. 11. Unable to interact and execute commands with the BaroPace modules during the screening phase. 12. Taking short-acting Nifedipine or Clonidine or taking ISA Beta Blockers; Acebutolol, Pindolol, Sectral or Visken.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy Evaluation Modified Bruce Protocol treadmill total exercise time Safety Evaluation Absence of Related Serious Adverse events Timepoint: At Screening Day, Day 7, Day 28, Day 49 From screening to end of study- Day 49 | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy Evaluation NYHA class Result of 6 min walk test comparing treatment & control Changes in Minnesota Living with Heart Failure Questionnaire compared to control Quality of life questions comparing treatment & control At least SBP drop more than or equal to 5 mmHg change from baseline At least DBP drop more than or equal to 3 mmHg change from baseline Reduction in the BP medications, number or dose Reduction in atrial fibrillation frequency compared to control Safety Evaluation Rate of intolerance to increases in right atrial pacing Timepoint: Day 0, 7, 28, 49 Day 0, 7, 28, 49 Day 0, 7, 28, 49 Every 12-hours After 21 days or less of treatment After 21 days or less of treatment On a daily or weekly basis Before each 12-hour treatment cycle At least one 12-hour treatment cycle | — |
Countries
India
Contacts
Public ContactDr Jayashri Krishnan
JSS Medical Research Asia pacific Private Limited
Outcome results
None listed