Status:
COMPLETED
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
Lead Sponsor:
BaroPace Inc.
Collaborating Sponsors:
JSS Medical Research Inc.
Conditions:
Heart Failure With Preserved Ejection Fraction (HFpEF)
Hypertension
Eligibility:
All Genders
35-90 years
Phase:
NA
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 Ejecti...
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 Ejecti...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
August 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 12 2024
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06036186
Start Date
August 26 2023
End Date
April 12 2024
Last Update
May 17 2024
Active Locations (3)
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1
Maharaja Agrasen Superspeciality Hospital, Clinical Research Department, Basement, Main Building, Room No-09, Sector-07, Agrasen Aspatal Marg, Central Spine, Vidyadhar Nagar,
Jaipur, Rajasthan, India, 302039
2
Dr. C. M. Chopra Hospital & Heart Care Centre
Jaipur, Rajasthan, India, 303702
3
L.P.S. Institute of Cardiology, G.S.V.M Medical College
Kanpur, Uttar Pradesh, India, 208002