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Exercise Capacity Before and After AF Ablation in Patients With HFpEF

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ClinicalTrials.gov Identifier: NCT05376748
Recruitment Status : Recruiting
First Posted : May 17, 2022
Last Update Posted : May 17, 2022
Sponsor:
Information provided by (Responsible Party):
Nicole Habel, MD, University of Vermont

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.

Condition or disease
Heart Failure With Preserved Ejection Fraction Atrial Fibrillation

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AF (defined as AF after a 12-week post-procedural blanking period accounting for post-ablation inflammation) will be withdrawn from the study and not proceed to the 4 month follow up visit.

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Study Type : Observational
Estimated Enrollment : 34 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Exercise Capacity in Patients With Heart Failure With Preserved Ejection Fraction Before and After Ablation of Atrial Fibrillation
Actual Study Start Date : April 15, 2022
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Change in peak VO2 [ Time Frame: before AF ablation and 4 months after AF ablation ]
    cardiopulmonary exercise testing will be performed & peak VO2 measured at baseline & follow up visit


Secondary Outcome Measures :
  1. Change in KCCQ score [ Time Frame: before and 4 months after AF ablation ]
    Kansas City Cardiomyopathy Questionnaire (KCCQ) will be obtained at baseline visit & again at ablation follow up visit. Scale 0-100 with higher scores signifying better quality of life.

  2. Percent change in NTproBNP [ Time Frame: before and 4 months after AF ablation ]
    Initial sample taken day of AF ablation as is standard of care; reassessed at 4 month f/u visit


Other Outcome Measures:
  1. Difference in peak VO2 in patient with vs. without chronic rate control [ Time Frame: 4 months post-ablation ]
    4 months f/u cardiopulmonary exercise testing performance compared between those with and without chronic rate control


Biospecimen Retention:   Samples Without DNA
Blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults with atrial fibrillation and HFpEF who are undergoing AF ablation
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05376748


Contacts
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Contact: Nicole Habel, MD 8028470000 nicole.habel@uvmhealth.org
Contact: Amy Henderson amy.henderson@uvmhealth.org

Locations
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United States, Vermont
University of Vermont Medical Center Recruiting
Burlington, Vermont, United States, 05405
Contact: Nicole Habel, MD       nicole.habel@uvmhealth.org   
Sponsors and Collaborators
University of Vermont
Investigators
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Principal Investigator: Nicole Habel, MD University of Vermont
Publications:
Sugumar H, Nanayakkara S, Vizi D, Chieng D, Leet A, Mariani J, Taylor A, Kalman J, Kistler P, Ling L. Impact of catheter ablation on HFpEF in people with comorbid atrial fibrillation and HFpEF using invasive haemodynamic testing. European Heart Journal. 2020; 41(2): ehaa946.0892.

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Responsible Party: Nicole Habel, MD, Principal Investigator, University of Vermont
ClinicalTrials.gov Identifier: NCT05376748    
Other Study ID Numbers: 00001607
First Posted: May 17, 2022    Key Record Dates
Last Update Posted: May 17, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Nicole Habel, MD, University of Vermont:
Ablation
HFpEF
atrial fibrillation
exercise capacity
peak oxygen consumption
Additional relevant MeSH terms:
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Heart Failure
Atrial Fibrillation
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes