Clinical trial NCT06775886: Effect of Personalized Accelerated Pacing in Symptomatic Patients With Non-Obstructive Hypertrophic Cardiomyopathy
Official title: Effect of Personalized Accelerated Pacing in Symptomatic Patients With Non-Obstructive Hypertrophic Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non-obstructive Hypertrophic Cardiomyopathy
Hypertrophic Cardiomyopathy
Keywords: Cardiomyopathy
Personalized Accelerated Pacing
Heart Failure with preserved Ejection Fraction (HFpEF)
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2025-01-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed description: 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. An interim data safety analysis will be conducted.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Health-Related Quality of Life (HRQoL) status
timeFrame: Baseline to 3 months
Secondary outcomes:
measure: Change in N-terminal pro-brain natriuretic peptide (NT-proBNP) levels
timeFrame: Baseline to 3 months
measure: Change in Peak Oxygen (pVO2) Uptake and predicted pVO2
timeFrame: Baseline to 3 months
measure: Change in pacemaker-detected atrial arrhythmia burden
timeFrame: Baseline to 3 months
measure: Change in pacemaker-detected patient activity level
timeFrame: Baseline to 3 months
measure: Change in echocardiographic parameters: Left Atrial (LA) Strain
timeFrame: Baseline to 3 months
measure: Change in echocardiographic parameters: Left Ventricular (LV) Strain
timeFrame: Baseline to 3 months
measure: Change in echocardiographic E/e' ratio
timeFrame: Baseline to 3 months
measure: Change in Left Ventricular Myocardial Thickness (LVMT)
timeFrame: Baseline to 3 months
measure: Change in Left Atrial (LA) chamber size
timeFrame: Baseline to 3 months
measure: Change in Left Ventricular (LV) chamber size
timeFrame: Baseline to 3 months
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Sandhya Murthy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.