Heart Failure With Preserved Ejection Fraction (HFpEF)RelieveHFpEFIINCT06036186
Study for the Treatment of Heart Failure With Preserved Ejection Fraction Associated With High Blood Pressure Using Right Atrial Pacing Controlled by the PressurePaceTM System
A study testing BaroPacing treatment and Standard treatment in people with Heart Failure With Preserved Ejection Fraction (HFpEF) and Hypertension, run by BaroPace Inc. at 3 sites in India.
Trial 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 PressurePace™ system of Right Atrial Pacing regulated by… Read more about this study
- Who is it for?
- Ages 35 to 90 years
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction (HFpEF), Hypertension
- What is being tested?
- BaroPacing treatment and Standard treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 3 sitesIndia
- Study dates
- 26 Aug 2023to 12 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
India3 sites
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
Dr. C. M. Chopra Hospital & Heart Care Centre
Jaipur, Rajasthan, 303702
L.P.S. Institute of Cardiology, G.S.V.M Medical College
Kanpur, Uttar Pradesh, 208002
About this study
Official title: 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 PressurePace™ System (RelieveHFpEF-II)
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.
Read the detailed description
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.
- Being tested
- BaroPacing treatment, Standard treatment
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaroPacing treatmentDevice
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).
Standard treatmentDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: BaroPacing treatment |
| 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). Receives: Device: Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Bruce Protocol treadmill total exercise time
Measured: At Screening Day, Day 7, Day 28, Day 49
Absence of Related Serious Adverse events
Measured: From screening to end of study- Day 49
Secondary outcomes (13)
NYHA class position
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: at the end of 21 days
Duration of response of Systolic blood pressure after lowering
Duration of response of SBP after lowering >= 5 mmHg
Measured: 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
Measured: 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
Measured: at the end of 21 days
Duration of response of diastolic blood pressure after lowering
Duration of response of DBP after lowering >= 3 mmHg
Measured: 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
Measured: at the end of 21 days
Reduction in atrial fibrillation
Reduction in atrial fibrillation monitored by telemetry and downloaded to PressurePace™
Measured: 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
Measured: every 12 hour visit on screening, first 7 days, randomization to 21-day period, in final 21 days, for total of 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start26 Aug 2023
- Primary completion12 Apr 2024
- Study completion12 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure With Preserved Ejection Fraction (HFpEF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- BaroPace Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- JSS Medical Research Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06036186
- Sponsor's protocol ID
- BP011
- Acronym
- RelieveHFpEFII
- Status last verified
- Sep 2023
- First submitted
- 16 Aug 2023
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41711731
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 PressurePace™ System (RelieveHFpEF-II)
- ClinicalTrials.gov ID
- NCT06036186
- Acronym / sponsor ID
- RelieveHFpEFII / BP011
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- BaroPace Inc.Industry (pharma, biotech, devices)
- Collaborators
- JSS Medical Research Inc.
- Study start
- 26 Aug 2023 (actual)
- Primary completion
- 12 Apr 2024 (actual)
- Study completion
- 12 Apr 2024 (actual)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BaroPacing treatment | Experimental | Device: BaroPacing treatmentGroup 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 | Device: Standard treatmentGroup 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). |
Who may qualify
- Ages
- 35 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BaroPacing treatmentBaroPacing 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). | Device | BaroPacing treatment |
| Standard treatmentIndividual 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). | Device | Standard treatment |
Primary outcome
Modified Bruce Protocol treadmill total exercise time
Time frame: At Screening Day, Day 7, Day 28, Day 49
Absence of Related Serious Adverse events
Time frame: From screening to end of study- Day 49
13 secondary outcomes
NYHA class position
Time frame: At Screening Day, Day 7, Day 28 and Day 49
Change from baseline of the total distance in 6 minutes
Time frame: At Screening Day, Day 7, Day 28, Day 49
Changes in The Minnesota Living with Heart Failure Questionnaire administered
Time frame: 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
Time frame: Every 12 hours throughout the 21 day treatment duration.
Systolic blood pressure change from baseline
Time frame: after 21 days or less of treatment
Proportion of subjects with a Systolic blood pressure drop
Time frame: at the end of 21 days
Duration of response of Systolic blood pressure after lowering
Time frame: at the end of 21 days
Drop in diastolic blood pressure change from baseline
Time frame: after 21 days or less of treatment
Proportion of subjects with a diastolic blood pressure drop
Time frame: at the end of 21 days
Duration of response of diastolic blood pressure after lowering
Time frame: at the end of 21 days
Reduction in the number of antihypertensive medications
Time frame: at the end of 21 days
Reduction in atrial fibrillation
Time frame: 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
Time frame: every 12 hour visit on screening, first 7 days, randomization to 21-day period, in final 21 days, for total of 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Derived from this study: PubMed 41711731Burnam 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BaroPacing treatment and Standard treatment in people with Heart Failure With Preserved Ejection Fraction (HFpEF) and Hypertension, run by BaroPace Inc. at 3 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Bruce Protocol treadmill total exercise time (time frame: At Screening Day, Day 7, Day 28, Day 49). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06036186, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.