| CTRI Number |
CTRI/2023/08/056316 [Registered on: 09/08/2023] Trial Registered Prospectively |
| Last Modified On: |
31/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Study for the Treatment of Heart Failure with Preserved Heart Function related to high blood pressure using Right upper chamber Pacing controlled by the PressurePaceTM System. |
|
Scientific Title of Study
|
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 PressurePaceâ„¢ System (RelieveHFpEF-II) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BP011, Version 4.0 dated 06 Jun 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jayashri Krishnan |
| Designation |
Vice President Operations |
| Affiliation |
JSS Medical Research Asia pacific Private Limited |
| Address |
Tower 2,1st Floor, South Wing, L and T Business Park, Plot no 12/4, Sector 27 D, Delhi Mathura Road, Near Sarai Khawja Metro Station, Faridabad, Haryana-121003, India.
Faridabad
HARYANA
121003
India |
| Phone |
09771407484 |
| Fax |
|
| Email |
Jayashri.krishnan@jssresearch.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Sathish Kumar P |
| Designation |
Medical Monitor |
| Affiliation |
JSS Medical Research Asia pacific Private Limited |
| Address |
Tower 2,1st Floor, South Wing, L and T Business Park, Plot no 12/4, Sector 27 D, Delhi Mathura Road, Near Sarai Khawja Metro Station, Faridabad, Haryana-121003, India.
Faridabad
HARYANA
121003
India |
| Phone |
7358005866 |
| Fax |
|
| Email |
sathish.p@jssresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayashri Krishnan |
| Designation |
Vice President Operations |
| Affiliation |
JSS Medical Research Asia pacific Private Limited |
| Address |
Tower 2,1st Floor, South Wing, L and T Business Park, Plot no 12/4, Sector 27 D, Delhi Mathura Road, Near Sarai Khawja Metro Station, Faridabad, Haryana-121003, India.
Faridabad
HARYANA
121003
India |
| Phone |
09771407484 |
| Fax |
|
| Email |
Jayashri.krishnan@jssresearch.com |
|
|
Source of Monetary or Material Support
|
| BaroPace Inc. 124 Manzanita Street, Ashland, Oregon 97520 |
|
|
Primary Sponsor
|
| Name |
BaroPace Inc. |
| Address |
124 Manzanita Street, Ashland, Oregon 97520 |
| Type of Sponsor |
Other [Medical Device Development Company] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| JSS Medical Research Asia Pacific Private Limited |
Tower 2, 1st Floor, South Wing, L&T Business Park, Plot no 12/4, Sector 27 D, Delhi Mathura Road, Near Sarai Khawja Metro Station,
Faridabad, Haryana, 121003,India
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rohit Chopra |
Dr. C.M. Chopra Hospital & Heart Care Centre |
Ground floor
Dr. C.M. Chopra Hospital & Heart Care Centre
Ganesh Vihar Colony, Jaipur Road, Chomu,
Jaipur,
Rajasthan- 303702
Jaipur
RAJASTHAN |
8867137737
Drrc2306@gmail.com |
| Dr Santosh Kumar Sinha |
LPS Institute of Cardiology & Cardiac Surgery, GSVM Medical College |
3rd floor
LPS Institute of Cardiology & Cardiac Surgery, GSVM Medical College, Swaroop Nagar Kanpur Uttar Pradesh India -208002
Kanpur Nagar
UTTAR PRADESH |
9670220088
lpsicardiologyresearch@gmail.com |
| Dr Sanjay Kumar Sharma |
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
Jaipur
RAJASTHAN |
9461011234
sanjaysharma.clinical@gmail.com |
| Dr Amitesh Nagarwal |
National Institute of Medical Science and Research |
3rd floor
Cardiac department
National Institute of Medical Science and Research
Shobha Nagar, Jaipur-Delhi Highway
NH-11C, Jaipur-303121, Rajasthan
Jaipur
RAJASTHAN |
9990137609
amitesh.nagarwal2007@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Ethics Committee GSVM Medical Collage Kanpur, GSVM Medical collage Swaroop Nagar Uttar Pradesh, India- 208002 |
Approved |
| Institutional Ethics Committee, Maharaja Agrasen Superspeciality Hospital, Jaipur |
Approved |
| Institutional EthicsCommittee Maharaja Agrasen Superspeciality Hospital, Central Spine, Agrasen Aspatal Marg, Sector-7, Vidyadhar Nagar, Jaipur, Rajasthan – 302039, India |
Approved |
| Institutional EthicsCommittee Maharaja Agrasen Superspeciality Hospital, Central Spine, Agrasen Aspatal Marg, Sector-7, Vidyadhar Nagar, Jaipur, Rajasthan – 302039, India |
Approved |
| Institutional EthicsCommittee Maharaja Agrasen Superspeciality Hospital, Central Spine, Agrasen Aspatal Marg, Sector-7, Vidyadhar Nagar, Jaipur, Rajasthan – 302039, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I503||Diastolic (congestive) heart failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
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). |
| Comparator Agent |
Standard treatment |
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). |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
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 < 90 of age.
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 < 50% and average intrinsic/pacing heart rate < 70 bpm over the previous clinical monitoring period of the pacemaker diagnostics of at least 14 days
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.
|
|
| ExclusionCriteria |
| Details |
1. 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.
2. A resting DBP > 120 mmHg, or < 80 at screening average over 3 measurements in 30 minutes.
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.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Efficacy Evaluation
Modified Bruce Protocol treadmill total exercise time
Safety Evaluation
Absence of Related Serious Adverse events
|
At Screening Day, Day 7, Day 28, Day 49
From screening to end of study- Day 49 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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
|
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 |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
19/08/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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 PressurePaceâ„¢ 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. |