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Heart Failure With Preserved Ejection FractionNCT05376748

Exercise Capacity Before and After AF Ablation in Patients With HFpEF

An observational study of Heart Failure With Preserved Ejection Fraction and Atrial Fibrillation, run by University of Vermont at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 110 years
How many people
34 participants
Where
1 siteUnited States
Study dates
15 Apr 2022to 30 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 110 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adults with atrial fibrillation and HFpEF who are undergoing AF ablation

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Nicole Habel, MD contact

8028470000

nicole.habel@uvmhealth.org

Amy Henderson contact

amy.henderson@uvmhealth.org

United States1 site, 1 recruiting

  • University of Vermont Medical Center

    Burlington, Vermont, 05405

    Nicole Habel, MD, nicole.habel@uvmhealth.org

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Keywords
Ablation, HFpEF, atrial fibrillation, exercise capacity, peak oxygen consumption
Medical subject headings
Atrial Fibrillation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in peak VO2

    cardiopulmonary exercise testing will be performed \& peak VO2 measured at baseline \& follow up visit

    Measured: before AF ablation and 4 months after AF ablation

Secondary outcomes (2)

  1. Change in KCCQ score

    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.

    Measured: before and 4 months after AF ablation

  2. Percent change in NTproBNP

    Initial sample taken day of AF ablation as is standard of care; reassessed at 4 month f/u visit

    Measured: before and 4 months after AF ablation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2022
  2. Study start15 Apr 2022
  3. Primary completion30 Jun 2024 (estimated)
  4. Study completion30 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05376748
Sponsor's protocol ID
00001607
Status last verified
Jun 2023
First submitted
25 Apr 2022
Last updated
22 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Oktay AA, Rich JD, Shah SJ. The emerging epidemic of heart failure with preserved ejection fraction. Curr Heart Fail Rep. 2013 Dec;10(4):401-10. doi: 10.1007/s11897-013-0155-7.

    PubMed 24078336

  • Vasan RS, Benjamin EJ, Levy D. Prevalence, clinical features and prognosis of diastolic heart failure: an epidemiologic perspective. J Am Coll Cardiol. 1995 Dec;26(7):1565-74. doi: 10.1016/0735-1097(95)00381-9.

    PubMed 7594087

  • Owan TE, Hodge DO, Herges RM, Jacobsen SJ, Roger VL, Redfield MM. Trends in prevalence and outcome of heart failure with preserved ejection fraction. N Engl J Med. 2006 Jul 20;355(3):251-9. doi: 10.1056/NEJMoa052256.

    PubMed 16855265

  • Haykowsky MJ, Brubaker PH, John JM, Stewart KP, Morgan TM, Kitzman DW. Determinants of exercise intolerance in elderly heart failure patients with preserved ejection fraction. J Am Coll Cardiol. 2011 Jul 12;58(3):265-74. doi: 10.1016/j.jacc.2011.02.055.

    PubMed 21737017

  • Mikkelsen N, Cadarso-Suarez C, Lado-Baleato O, Diaz-Louzao C, Gil CP, Reeh J, Rasmusen H, Prescott E. Improvement in VO2peak predicts readmissions for cardiovascular disease and mortality in patients undergoing cardiac rehabilitation. Eur J Prev Cardiol. 2020 May;27(8):811-819. doi: 10.1177/2047487319887835. Epub 2019 Nov 19.

    PubMed 31744334

  • Swank AM, Horton J, Fleg JL, Fonarow GC, Keteyian S, Goldberg L, Wolfel G, Handberg EM, Bensimhon D, Illiou MC, Vest M, Ewald G, Blackburn G, Leifer E, Cooper L, Kraus WE; HF-ACTION Investigators. Modest increase in peak VO2 is related to better clinical outcomes in chronic heart failure patients: results from heart failure and a controlled trial to investigate outcomes of exercise training. Circ Heart Fail. 2012 Sep 1;5(5):579-85. doi: 10.1161/CIRCHEARTFAILURE.111.965186. Epub 2012 Jul 6.

    PubMed 22773109

  • Nadruz W Jr, West E, Sengelov M, Santos M, Groarke JD, Forman DE, Claggett B, Skali H, Shah AM. Prognostic Value of Cardiopulmonary Exercise Testing in Heart Failure With Reduced, Midrange, and Preserved Ejection Fraction. J Am Heart Assoc. 2017 Oct 31;6(11):e006000. doi: 10.1161/JAHA.117.006000.

    PubMed 29089342

  • Reddy YNV, Obokata M, Verbrugge FH, Lin G, Borlaug BA. Atrial Dysfunction in Patients With Heart Failure With Preserved Ejection Fraction and Atrial Fibrillation. J Am Coll Cardiol. 2020 Sep 1;76(9):1051-1064. doi: 10.1016/j.jacc.2020.07.009.

    PubMed 32854840

  • Elshazly MB, Senn T, Wu Y, Lindsay B, Saliba W, Wazni O, Cho L. Impact of Atrial Fibrillation on Exercise Capacity and Mortality in Heart Failure With Preserved Ejection Fraction: Insights From Cardiopulmonary Stress Testing. J Am Heart Assoc. 2017 Oct 31;6(11):e006662. doi: 10.1161/JAHA.117.006662.

    PubMed 29089343

  • Anderson L, Oldridge N, Thompson DR, Zwisler AD, Rees K, Martin N, Taylor RS. Exercise-Based Cardiac Rehabilitation for Coronary Heart Disease: Cochrane Systematic Review and Meta-Analysis. J Am Coll Cardiol. 2016 Jan 5;67(1):1-12. doi: 10.1016/j.jacc.2015.10.044.

    PubMed 26764059

  • O'Connor CM, Whellan DJ, Lee KL, Keteyian SJ, Cooper LS, Ellis SJ, Leifer ES, Kraus WE, Kitzman DW, Blumenthal JA, Rendall DS, Miller NH, Fleg JL, Schulman KA, McKelvie RS, Zannad F, Pina IL; HF-ACTION Investigators. Efficacy and safety of exercise training in patients with chronic heart failure: HF-ACTION randomized controlled trial. JAMA. 2009 Apr 8;301(14):1439-50. doi: 10.1001/jama.2009.454.

    PubMed 19351941

  • Belardinelli R, Georgiou D, Cianci G, Purcaro A. Randomized, controlled trial of long-term moderate exercise training in chronic heart failure: effects on functional capacity, quality of life, and clinical outcome. Circulation. 1999 Mar 9;99(9):1173-82. doi: 10.1161/01.cir.99.9.1173.

    PubMed 10069785

  • Tamargo M, Obokata M, Reddy YNV, Pislaru SV, Lin G, Egbe AC, Nishimura RA, Borlaug BA. Functional mitral regurgitation and left atrial myopathy in heart failure with preserved ejection fraction. Eur J Heart Fail. 2020 Mar;22(3):489-498. doi: 10.1002/ejhf.1699. Epub 2020 Jan 7.

    PubMed 31908127

  • Kaye DM, Silvestry FE, Gustafsson F, Cleland JG, van Veldhuisen DJ, Ponikowski P, Komtebedde J, Nanayakkara S, Burkhoff D, Shah SJ. Impact of atrial fibrillation on rest and exercise haemodynamics in heart failure with mid-range and preserved ejection fraction. Eur J Heart Fail. 2017 Dec;19(12):1690-1697. doi: 10.1002/ejhf.930. Epub 2017 Oct 11.

    PubMed 29024227

  • Fukasawa K, Fukuda K, Mori N, Kondo M, Chiba T, Miki K, Hasebe Y, Nakano M, Shimokawa H. Impacts of sinus rhythm maintenance with catheter ablation on exercise tolerance in patients with paroxysmal atrial fibrillation. J Interv Card Electrophysiol. 2021 Jun;61(1):105-113. doi: 10.1007/s10840-020-00786-y. Epub 2020 Jun 1.

    PubMed 32488748

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure With Preserved Ejection Fraction and Atrial Fibrillation, run by University of Vermont at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Nicole Habel, MD (8028470000, nicole.habel@uvmhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in peak VO2 (time frame: before AF ablation and 4 months after AF ablation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05376748, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.

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Clinical Trial NCT05376748 | AzTrials