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

NCT06036186 | Completed

• 1 other identifier: BP011
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 3

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 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.

Conditions

Heart Failure With Preserved Ejection Fraction (HFpEF); Hypertension

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (13)

• NYHA class position

  At Screening Day, Day 7, Day 28 and Day 49

• Change from baseline of the total distance in 6 minutes

  At Screening Day, Day 7, Day 28, Day 49

• Changes in The Minnesota Living with Heart Failure Questionnaire administered

  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

  Every 12 hours throughout the 21 day treatment duration.

• Systolic blood pressure change from baseline

  after 21 days or less of treatment

Other Outcomes (5)

• Feasibility of real-time closed loop programming of a pacemaker atrial rate based on controlled algorithm.

  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™

  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.

  every 12 hour visit on screening, first 7 days, randomization to 21-day period, and in final 21 days, for total of 7 weeks

Study Arms (2)

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).

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).

Device: Standard treatment

Interventions

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).

BaroPacing treatment

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).

Standard treatment

Eligibility Criteria

• Age: 35 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• BaroPace Inc.: lead
• JSS Medical Research Inc.: collaborator

Study Sites (3)

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

Location

Dr. C. M. Chopra Hospital & Heart Care Centre

Jaipur, Rajasthan, 303702, India

Location

L.P.S. Institute of Cardiology, G.S.V.M Medical College

Kanpur, Uttar Pradesh, 208002, India

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2023
• First Posted: September 13, 2023
• Study Start: August 26, 2023
• Primary Completion: April 12, 2024
• Study Completion: April 12, 2024
• Last Updated: May 17, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (3)