Phase
Condition
Heart Failure
Chest Pain
Congestive Heart Failure
Treatment
Pacemaker PLR + TRT ON
Pacemaker PLR ON
Pacemaker non-pacing mode or an exertional rate-adaptive pacing mode with no planned pacing at rest.
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Diagnosis of Heart Failure, Left Ventricular Ejection Fraction (LVEF) ≥ 55% (thisand other measurements must be made within the last year).
New York Heart Association (NYHA) Functional Class I-III
Stable on guideline-directed medical therapy (GDMT) heart failure medications asdetermined by the investigator, for at least 1 month, with the exception of loopdiuretic therapy. GDMT should be in accordance with current American HeartAssociation (AHA)/American College of Cardiology (ACC)/Heart Failure Society ofAmerica (HFSA) Guidelines and include consideration of Sodium/glucosecotransporter-2 inhibitors (SGLT2i) therapy.
V End Diastolic Volume indexed to body surface area (BSA) ≤ 80 mL/m^2.
Concentric remodeling or concentric hypertrophy defined as at least one of thefollowing criteria:
Left ventricular (LV) posterior or lateral wall thickness > 11mm
Relative wall thickness (RWT) > 0.42
Male and LV mass indexed to BSA ≥115 g/m2
Male and LV mass indexed to height ≥ 49.2 g/m2.7
Female and LV mass indexed to BSA ≥ 95 g/m2
Female and LV mass indexed to height ≥ 46.7 g/m2.7
Exclusion
Exclusion Criteria:
Unable or unwilling to undergo contrast MRI.
Class I indication for permanent pacing, except for symptomatic chronotropicincompetence
Current permanent or persistent Atrial fibrillation (A-fib)
Structural heart disease requiring intervention
Aortic valve replacement procedure less than 12 months prior to enrollment
Known pericardial constriction, genetic hypertrophic cardiomyopathy, or infiltrativecardiomyopathy
Severe aortic or mitral valve disease, defined as severe regurgitation or a valvearea < 1cm^2
Exertional angina
Severe pulmonary disease including severe Chronic obstructive pulmonary disease (COPD) (i.e., requiring home oxygen, chronic nebulizer therapy, or chronic oralsteroid therapy or hospitalized for pulmonary decompensation within 12 months)
Estimated glomerular filtration rate (eGFR) < 25 ml/min/1.73m^2 as calculated by theModification in Diet in Renal Disease (MDRD) formula
Uncontrolled blood pressure, defined as systolic pressure outside the range of 100to 160 mmHg despite anti-hypertensive medication.
Study Design
Study Description
Connect with a study center
NCH Heart Institute
Naples, Florida 34102
United StatesActive - Recruiting
AdventHealth CV Research Institute
Orlando, Florida 32746
United StatesSite Not Available
Emory University Hospital
Atlanta, Georgia 30308
United StatesSite Not Available
Prairie Education and Research Cooperative-St. Elizabeth's
O'Fallon, Illinois 62269
United StatesSite Not Available
Prairie Education and Research Cooperative
Springfield, Illinois 62769
United StatesActive - Recruiting
Prairie Education and Research Cooperative-St. John's
Springfield, Illinois 62769
United StatesActive - Recruiting
University of Kansas Medical Center
Kansas City, Kansas 66160
United StatesActive - Recruiting
Duke University
Durham, North Carolina 27708
United StatesActive - Recruiting
Oklahoma Heart Hospital
Oklahoma City, Oklahoma 73120
United StatesActive - Recruiting
Dallas VA Medical Center
Dallas, Texas 75216
United StatesSite Not Available
Houston Methodist Research Institute
Houston, Texas 77030
United StatesActive - Recruiting
The University of Vermont Medical Center
Burlington, Vermont 05401
United StatesSite Not Available
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