Exercise Capacity Before and After AF Ablation in Patients With HFpEF

June 20, 2023 updated by: Nicole Habel, MD, University of Vermont

Exercise Capacity in Patients With Heart Failure With Preserved Ejection Fraction Before and After Ablation of Atrial Fibrillation

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.

Study Overview

Status

Recruiting

Conditions

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AF (defined as AF after a 12-week post-procedural blanking period accounting for post-ablation inflammation) will be withdrawn from the study and not proceed to the 4 month follow up visit.

Study Type

Observational

Enrollment (Estimated)

34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 110 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults with atrial fibrillation and HFpEF who are undergoing AF ablation

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
before AF ablation and 4 months after AF ablation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
before and 4 months after AF ablation
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
before and 4 months after AF ablation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 months post-ablation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Vermont

Investigators

  • Principal Investigator: Nicole Habel, MD, University of Vermont

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2022

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

April 25, 2022

First Submitted That Met QC Criteria

May 12, 2022

First Posted (Actual)

May 17, 2022

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 20, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00001607

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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