Clinical trial NCT05376748: Exercise Capacity Before and After AF Ablation in Patients With HFpEF
Official title: Exercise Capacity in Patients With Heart Failure With Preserved Ejection Fraction Before and After Ablation of Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure With Preserved Ejection Fraction
Atrial Fibrillation
Keywords: Ablation
HFpEF
atrial fibrillation
exercise capacity
peak oxygen consumption
Lead sponsor: University of Vermont
Sponsor class: OTHER
First posted: 2022-05-17
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with atrial fibrillation and HFpEF who are undergoing AF ablation

Brief summary: In a prospective, observational pilot study of patients scheduled for an atrial fibrillation (AF) ablation at the University of Vermont Medical Center the investigators will compare exercise capacity before and four months after AF ablation.

Detailed description: Patients ≥ 18 years of age who are scheduled for an AF ablation at the University of Vermont Medical Center will be screened for the following inclusion criteria: H2FpEF score of ≥ 6 (corresponding to ≥90% probability of HFpEF (19)) AND echocardiogram within the past 2 years that reported a LV ejection fraction ≥ 50% AND at least one symptom of HF (dyspnea on exertion, orthopnea or paroxysmal nocturnal dyspnea). Exclusion criteria: (1) Life expectancy \<12 months, (2) moderate or more valvular disease, (3) inability to walk on a treadmill. Patients with early recurrent AF (defined as AF after a 12-week post-procedural blanking period accounting for post-ablation inflammation) will be withdrawn from the study and not proceed to the 4 month follow up visit.

Eligibility criteria: Inclusion Criteria:

* H2FpEF score of ≥ 6 (corresponding to \>90% probability of HFpEF (19))
* echocardiogram within the past 2 years that reported a LV ejection fraction ≥ 50%
* at least one symptom of HF (dyspnea on exertion, orthopnea or paroxysmal nocturnal dyspnea).
* AF ablation scheduled at UVMMC

Exclusion Criteria:

* Life expectancy \<12 months
* moderate or more valvular disease
* inability to walk on a treadmill

Primary outcomes:
measure: Change in peak VO2
timeFrame: before AF ablation and 4 months after AF ablation
Secondary outcomes:
measure: Change in KCCQ score
timeFrame: before and 4 months after AF ablation
measure: Percent change in NTproBNP
timeFrame: before and 4 months after AF ablation
Other outcomes:
measure: Difference in peak VO2 in patient with vs. without chronic rate control
timeFrame: 4 months post-ablation
Locations:
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
Study officials:
affiliation: University of Vermont
name: Nicole Habel, MD
role: PRINCIPAL_INVESTIGATOR
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