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| Name | Class |
|---|---|
| JSS Medical Research Inc. | INDUSTRY |
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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 PressurePace⢠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.
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 PressurePace⢠system of Right Atrial Pacing regulated by blood pressure in subjects with dual chamber pacemakers. No surgery, intervention or implant will occur during this study. All subjects enrolled in the study already have a dual chamber pacemaker implanted for standard clinical indications.
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.
Each subject will have an office/clinic visit. Once the subject signs informed consent, the pacemaker will be interrogated by trained personnel. If all the inclusion/exclusion criteria are met, then the pacemaker will be connected to the pacemaker manufacturer's interrogation module which will be connected to the BaroPace interface. The system will run with clinical oversight in the office to determine suitability for outpatient function and subject usability. The system will then be used by the subjects for the duration of the study always with the direct supervision of a trained Clinical Research Coordinators.
Subjects that met all inclusion and exclusion criteria will be entered into the baseline phase (Day 1 to Day 7) where subjects will continue to receive their baseline antihypertensive medications while on standard baseline pacing parameters. Subjects will have at baseline screening day and day 7, 24-hour Ambulatory BP monitoring (ABPM). On Screening Day subjects will undergo a 2 D echo to assess ejection fraction, 6-Minute Walk test and a treadmill using the Modified Bruce Protocol on screening and Day 7. On Day 7, if subject has >3 lbs. weight loss, or >10 mmHg drop in SBP or >5 mmHg drop in DBP (mean of the past 3 12-hour BP readings at home) or is unable to tolerate at least 3 minutes on the Modified Bruce Protocol treadmill, or walk at least 225 meters during the 6-Minute Walk test, the subject will be discontinued from the study. Subjects that continue in the study will be randomized into two groups (8 subjects in each group), 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). Group 2 will use standard treatment for the first 3 weeks (day 8 to day 28) and then switch to BaroPacing for another 3 weeks (day 29 to day 49). Total study duration for a subject will be 7 weeks (49 +/- 5 days).
At the end of 49 days, the subject will return to the office/clinic, the external system components will be disconnected, and the subject's pacemaker will be returned to pre-study parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BaroPacing treatment | Experimental | 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). |
|
| Standard treatment | Active Comparator | Group 2 will use standard treatment for the first 3 weeks (day 8 to day 28) and then switch to BaroPacing for another 3 weeks (day 29 to day 49). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BaroPacing treatment | Device | BaroPacing for the first 3 weeks (day 8 to day 28) and then crossover to standard treatment for another 3 weeks (day 29 to day 49). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Modified Bruce Protocol treadmill total exercise time | At Screening Day, Day 7, Day 28, Day 49 | |
| Absence of Related Serious Adverse events | From screening to end of study- Day 49 |
| Measure | Description | Time Frame |
|---|---|---|
| NYHA class position | At Screening Day, Day 7, Day 28 and Day 49 | |
| Change from baseline of the total distance in 6 minutes | The change from baseline on the 7th day of the total distance in 6 minutes, in meters, that the patient can walk compared to 6 minutes walked on day 28 and 49. Baseline will be compared to both treatment and control. The 6-minute walk test will be performed according to the American Thoracic Society guidelines. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of real-time closed loop programming of a pacemaker atrial rate based on controlled algorithm. | real time programming worked=1, did not work=0 | every 12 hour visit on screening, first 7 days, randomization to 21-day period, and in final 21 days, for total of 7 weeks |
| Feasibility of subject's real-time subjective inputs as a moderator of pacemaker atrial rate function and PressurePace⢠|
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maharaja Agrasen Superspeciality Hospital, Clinical Research Department, Basement, Main Building, Room No-09, Sector-07, Agrasen Aspatal Marg, Central Spine, Vidyadhar Nagar, | Jaipur | Rajasthan | 302039 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41711731 | Derived | Burnam MH, Sinha SK, Jha MJ, Sharma SK, Nagarwal A, Chopra R, Gang ES. Adaptive blood pressure-modulated atrial pacing in hypertensive HFpEF patients: a randomized, first-in-human study. ESC Heart Fail. 2026 Feb 3;13(1):xvaf020. doi: 10.1093/eschf/xvaf020. |
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| Standard treatment | Device | Individual Standard treatment as prescribed by the Physician to each subject for the first 3 weeks (day 8 to day 28) and then crossover to BaroPacing for another 3 weeks (day 29 to day 49). |
|
| At Screening Day, Day 7, Day 28, Day 49 |
| Changes in The Minnesota Living with Heart Failure Questionnaire administered | The Minnesota Living with Heart Failure Questionnaire is a quality-of-life questionnaire. At every 12-hour interval during the study the subject will be asked on the computer tablet a few questions, asking how much you're the treatment has affected the enrolled subject's life on a scale of 0, 1, 2, 3, 4 or 5. Zero denoting no adverse affect on life and 5 denoting very much adverse affect on life. | At Screening Day, Day 7, Day 28, Day 49 |
| Quality of life questions for measuring changes in sense of well-being during intervals of perceived changes in RA pacing | It is a 3 point scale, Better=2, same=1 worse=0 reduction of Afib: How many episodes in a 21 day period. | Every 12 hours throughout the 21 day treatment duration. |
| Systolic blood pressure change from baseline | At least 5 mmHg drop in systolic blood pressure change from baseline | after 21 days or less of treatment |
| Proportion of subjects with a Systolic blood pressure drop | Proportion of subjects with a SBP drop >= 5 mmHg | at the end of 21 days |
| Duration of response of Systolic blood pressure after lowering | Duration of response of SBP after lowering >= 5 mmHg | at the end of 21 days |
| Drop in diastolic blood pressure change from baseline | At least 3 mmHg drop in diastolic blood pressure change from baseline | after 21 days or less of treatment |
| Proportion of subjects with a diastolic blood pressure drop | Proportion of subjects with a DBP drop >= 3 mmHg | at the end of 21 days |
| Duration of response of diastolic blood pressure after lowering | Duration of response of DBP after lowering >= 3 mmHg | at the end of 21 days |
| Reduction in the number of antihypertensive medications | Reduction in the number of antihypertensive medications or a reduction in milligrams of one or more medications | at the end of 21 days |
| Reduction in atrial fibrillation | Reduction in atrial fibrillation monitored by telemetry and downloaded to PressurePace⢠| every 12 hour visit on screening, first 7 days, randomization to 21-day period, in final 21 days, for total of 7 weeks |
| Rate of intolerance to increases in right atrial pacing | Rate of intolerance to increases in right atrial pacing requiring reduction to a prior lower level of right atrial pacing | every 12 hour visit on screening, first 7 days, randomization to 21-day period, in final 21 days, for total of 7 weeks |
real-time inputs resulted in moderating pacemaker atrial rate worked=1, did not =0 |
| every 12 hour visit on screening, first 7 days, randomization to 21-day period, and in final 21 days, for total of 7 weeks |
| Real-time closed-loop performance of commands to regulate atrial rate pacing parameters. | worked=1, did not work=0 | every 12 hour visit on screening, first 7 days, randomization to 21-day period, and in final 21 days, for total of 7 weeks |
| Subject's report of changes in sense of well-being during intervals of increased right atrial pacing. | Reported no change=1, reported change to un-well =0 | every 12 hour visit on screening, first 7 days, randomization to 21-day period, and in final 21 days, for total of 7 weeks |
| Subjective inputs by the subject on how he/she is feeling | Reported yes=1 reported no=0 | every 12 hour visit on screening, first 7 days, randomization to 21-day period, and in final 21 days, for total of 7 weeks |
| Dr. C. M. Chopra Hospital & Heart Care Centre | Jaipur | Rajasthan | 303702 | India |
| L.P.S. Institute of Cardiology, G.S.V.M Medical College | Kanpur | Uttar Pradesh | 208002 | India |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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