Evidence map›Paper›PMID 41711731›Full record

Trial reportESC heart failure2026

Adaptive blood pressure-modulated atrial pacing in hypertensive HFpEF patients: a randomized, first-in-human study.

Michael H Burnam, Santosh Kumar Sinha, Mukesh Jitendra Jha, Sanjay Kumar Sharma, Amitesh Nagarwal, Rohit Chopra, Eli S Gang

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in ESC heart failure, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06036186 (Early Feasibility, Randomized Crossover and Double-Blind Design, Study for the Treatment of Heart Failure With Preserved Ejection Fraction), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
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1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06036186 nacompletednot on this map

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)

TypeinterventionalSponsorBaroPace Inc.Ran2023 to 2024Enrolled16ConditionsHeart Failure With Preserved Ejection Fraction (HFpEF), HypertensionArmsBaroPacing treatment, Standard treatment
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Michael H BurnamBaroPace, Inc., Issaquah, WA, USA.
Santosh Kumar SinhaL.P.S Institute of Cardiology & Cardiac Surgery, GSVM Medical College, Swaroop Nagar, Kanpur, Uttar Pradesh, India.
Mukesh Jitendra JhaL.P.S Institute of Cardiology & Cardiac Surgery, GSVM Medical College, Swaroop Nagar, Kanpur, Uttar Pradesh, India.
Sanjay Kumar SharmaCardiology Department, Maharaja Agrasen Superspeciality Hospital, Jaipur, India.
Amitesh NagarwalCardiology Department, NIMS Medical College, NIMS University, Jaipur, India.
Rohit ChopraCardiology Department, C M Chopra Hospital & Heart Care Centre, Chomu, India.
Eli S GangBaroPace, Inc., Issaquah, WA, USA.

Funding

BaroPace Inc. Issaquah, WA
6 · The paper itself

Abstract

introductionHeart failure with preserved ejection fraction (HFpEF) represents approximately 50% of all heart failure cases and lacks effective treatments. Chronotropic incompetence contributes to exercise intolerance in these patients. This study evaluated the safety and efficacy of blood pressure-adaptive atrial pacing (BPAP) vs standard bradycardia pacing (STD) in hypertensive patients with HFpEF.

methodsIn this prospective, double-blind, randomized, self-controlled crossover study, 16 patients (mean age: 62.7 ± 10.9 years; 6% female; left ventricular ejection fraction 55.3 ± 3.8%) with treated hypertension and implanted dual-chamber pacemakers underwent two 3-week treatment phases (BPAP and STD) in random order. The BPAP algorithm-modulated atrial pacing rate in response to home blood pressure readings. Endpoints included the Minnesota Living With Heart Failure (MLWHF) score, New York Heart Association (NYHA) class, 6-minute walk test (6MWT), and modified Bruce treadmill test.

resultsBPAP improved MLWHF score by an additional 15% from baseline (P = .0288), whereas STD showed a non-significant 3% worsening. Exercise time increased significantly during BPAP (+83.2 ± 55.6 s, P = .005) but not during STD (+70.8 ± 84.4 s, P = .095). The 6MWT distance rose by 35.8 ± 29.9 m during BPAP (P = .003) vs minimal change with STD (+8.2 ± 40.1 m, P = .6). NYHA class improved in 55.6% of BPAP patients vs 11% with STD (P = .0455). Mean heart rate was higher during BPAP (83.8 ± 8.3 bpm) than STD (72.9 ± 12.0 bpm, P < .0001), with no difference in systolic blood pressure (137.5 ± 14.9 vs 138.6 ± 14.0 mmHg, P = .68). No adverse events occurred.

conclusionIn hypertensive patients with HFpEF and implanted pacemakers, BPAP safely improved exercise capacity and functional status compared to standard pacing. The approach demonstrates feasibility of home-based blood pressure-modulated pacing for physiologic rate adaptation. (NCT06036186).

Indexed as

Blood PressureCardiac Pacing, ArtificialExercise ToleranceHeart FailureHypertensionStroke VolumeAgedCross-Over StudiesDouble-Blind MethodFemaleFollow-Up StudiesHeart AtriaHeart RateHumansMaleMiddle AgedCardiac PacingChronotropic incompetenceExercise toleranceHFpEFHypertensionRate adaptive atrial pacing

Identifiers

PMID41711731
PMCPMC13108269

What Socratic holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.