Effect of Personalized Accelerated Pacing in Symptomatic Patients With Non-Obstructive Hypertrophic Cardiomyopathy

NCT06775886 | Terminated DMC

• 1 other identifier: 2024-16244
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a two-arm investigator-initiated randomized controlled study of patients with nHCM and LV ejection fraction ≥50% and NYHA II-III symptoms, normal intrinsic conduction system and pre-existing suitable dual-chamber implantable cardioverter defibrillators (ICD) systems. Patients will be randomly assigned to either personalized accelerated pacing (using the myPACE+ algorithm with mono-fractional exponent) or usual care groups. At baseline and after 3 months of pacing all patients will undergo a CPET, echocardiogram, blood work for NT-proBNP levels and complete the KCCQ-OSS and HCMSQ, questionnaires. The investigator team hypothesizes that personalized accelerated pacing will be safe and improve symptoms and heart-failure related quality of life, physical activity, pVO2, biomarkers (i.e. NT-proBNP), diastolic parameters and cardiac structure.

Conditions

Non-obstructive Hypertrophic Cardiomyopathy; Hypertrophic Cardiomyopathy

Keywords

Cardiomyopathy; Personalized Accelerated Pacing; Heart Failure with preserved Ejection Fraction (HFpEF)

Outcome Measures

Primary Outcomes (1)

• Change in Health-Related Quality of Life (HRQoL) status

  Change in HRQoL from prior to randomization to the time of 3-month follow-up will be assessed based on patient responses to the 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12). The KCCQ-12 is a validated health status measure for patients with heart failure. An overall summary score (OSS) is tabulated based on responses ranging from 0-100, with 0 denoting the worst and 100 the best possible HRQoL status. Change from baseline scores will be summarized by study arm using basic descriptive statistics. A logistic mixed-effect model will be employed to calculate the odds ratio for a ≥ 5 point or more improvement of the KCCQ-OSS, which is considered clinically meaningful.

  Baseline to 3 months

Secondary Outcomes (10)

• Change in N-terminal pro-brain natriuretic peptide (NT-proBNP) levels

  Baseline to 3 months

• Change in Peak Oxygen (pVO2) Uptake and predicted pVO2

  Baseline to 3 months

• Change in pacemaker-detected atrial arrhythmia burden

  Baseline to 3 months

• Change in pacemaker-detected patient activity level

  Baseline to 3 months

• Change in echocardiographic parameters: Left Atrial (LA) Strain

  Baseline to 3 months

Study Arms (2)

myPACE+

EXPERIMENTAL

Participants will be programmed to a personalized lower rate setting based on the myPACE+ resting heart rate algorithm will be conducted using the myPACE+ algorithm

Other: myPACE+ algorithm

Usual Care

NO INTERVENTION

Standard of care. Participants will retain a standard pacing lower rate setting of 60 beats per minute (bpm).

Interventions

myPACE+ algorithm OTHER

myPACE+ algorithm with mono-fractional exponent

myPACE+

Eligibility Criteria

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

You may qualify if:

• Non obstructive HCM: Left Ventricular Outflow Tract (LVOT) gradient \<30mmHg at rest and with provocation
• Left ventricular ejection fraction (LVEF) ≥50%
• New York Heart Association (NYHA II-III) symptoms
• Normal intrinsic conduction system
• Suitable dual-chamber implantable cardioverter defibrillators (ICD) system

You may not qualify if:

• Pregnancy
• LVEF \<50%
• LVOT gradient \> 30mmHg at rest or with provocation
• Prolonged PR \> 250ms
• Baseline RV-pacing burden of \> 1% more than moderate valvular stenosis or regurgitation
• Aortic valve replacement in the past one year
• Significant primary pulmonary disease on home oxygen
• Uncontrolled hypertension as defined by BP \>160/100 mmHg on two measurements ≥15 minutes apart

Sponsors & Collaborators

• Montefiore Medical Center: lead
• Medtronic: collaborator

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Publications (4)

• Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2022 May 3;79(17):1757-1780. doi: 10.1016/j.jacc.2021.12.011. Epub 2022 Apr 1.

  PMID: 35379504 BACKGROUND

• Ommen SR, Mital S, Burke MA, Day SM, Deswal A, Elliott P, Evanovich LL, Hung J, Joglar JA, Kantor P, Kimmelstiel C, Kittleson M, Link MS, Maron MS, Martinez MW, Miyake CY, Schaff HV, Semsarian C, Sorajja P. 2020 AHA/ACC Guideline for the Diagnosis and Treatment of Patients With Hypertrophic Cardiomyopathy: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2020 Dec 22;76(25):3022-3055. doi: 10.1016/j.jacc.2020.08.044. Epub 2020 Nov 20.

  PMID: 33229115 BACKGROUND

• Infeld M, Wahlberg K, Cicero J, Plante TB, Meagher S, Novelli A, Habel N, Krishnan AM, Silverman DN, LeWinter MM, Lustgarten DL, Meyer M. Effect of Personalized Accelerated Pacing on Quality of Life, Physical Activity, and Atrial Fibrillation in Patients With Preclinical and Overt Heart Failure With Preserved Ejection Fraction: The myPACE Randomized Clinical Trial. JAMA Cardiol. 2023 Mar 1;8(3):213-221. doi: 10.1001/jamacardio.2022.5320.

  PMID: 36723919 BACKGROUND

• Weissler-Snir A, Rakowski H, Meyer M. Beta-blockers in non-obstructive hypertrophic cardiomyopathy: time to ease the heart rate restriction? Eur Heart J. 2023 Oct 1;44(37):3655-3657. doi: 10.1093/eurheartj/ehad518. No abstract available.

  PMID: 37650505 BACKGROUND

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic; Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Officials

• Luigi Di Biase, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Researchers collecting pacemaker-detected endpoints cannot be blinded to the rate setting.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 15, 2025
• Study Start: October 2, 2025
• Primary Completion: October 23, 2025
• Study Completion: October 23, 2025
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)