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Aortic Valve StenosisFitTAVINCT03966417

Exercise Training After Transcatheter Aortic Valve Implantation

A study testing Exercise training in people with Aortic Valve Stenosis and TAVI, run by University Medical Centre Ljubljana at 1 site in Slovenia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this prospective, controlled trial, patient after TAVI will be randomized to either exercise training or usual care group. Read more about this study

Who is it for?
Ages 18 to 99 years
What is being tested?
Exercise training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteSlovenia
Study dates
18 Jun 2019to 1 Dec 2020
Phase
Interventional
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 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • TAVI procedure 3-6 months prior to inclusion,
  • movability (100 meters or more on 6-minute walking test after TAVI),
  • ability to attend a 12 week exercise training program,
  • physical and clinical ability to attend the rehabilitation program at the discretion of the researcher,
  • optimal medical treatment,
  • pre-signed statement of a conscious and free consent to the inclusion in the clinical trial.

Who cannot join

  • contraindications for exercise training,
  • unstable hearth (uncontrollable heart failure - New York Heart Association stage IV, dysrhythmias, uncontrollable myocardial ischemia),
  • patient's decision to undergo TAVI despite receiving a recommendation for Surgical Aortic Valve Repair by the heart team,
  • non-cardiac physical impairment that would prevent exercise training on stationary bike,
  • uncontrolled pulmonary disease (FEV1 <50%),
  • echocardiographic signs of prosthesis dysfunction according to the Valve Academic Research Consortium (valve orifice area of b1.2 cm2 plus a mean transaortic pressure gradient of ≥20 mm Hg, or a velocity of ≥3 m/s, at least moderate paravalvular regurgitation),
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  • TAVI access site complication,
  • important peripheral vascular disease, musculoskeletal disease or central nervous system disease, which prevents exercise training on stationary bike,
  • recent (less than 3 months) acute events or illnesses that are contraindications for exercise training.

Trial locations and contacts

1 site in 1 country.

Slovenia1 site

  • UMC Ljubljana

    Ljubljana, 1000

Other trials in Slovenia

About this study

In this prospective, controlled trial, patient after TAVI will be randomized to either exercise training or usual care group.

Read the detailed description

Patients after transcatheter aortic valve replacement (TAVI) are particularly old and severely deconditioned and are thus likely to benefit from cardiac rehabilitation programs. In this controlled trial, patients after TAVI will be randomized to either exercise training or usual care.

The aim of our study is to compare the effect of exercise training vs. usual care on:

  1. exercise capacity
  2. vascular function
  3. parameters of heart failure, inflammation and homeostasis
  4. arrhythmogenic potential
  5. health-related quality of life
Being tested
Exercise training
Keywords
exercise training
Medical subject headings
Aortic Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise trainingOther

    Also called Rehabilitation

    Continuous exercise training 2 times per week for a period of 12 weeks.

Study groups in NCT03966417
Study groupRoleWhat they receive
Exercise training groupActive comparatorPatient to be randomized to "exercise training group" will have exercise training sessions 2 times per week for a period of 12 weeks. They will undergo moderate continuous exercise training at 75% of Vo2max.
Receives: Other: Exercise training
Usual care groupNo interventionPatient to be randomized to "usual care group" will undergo standard care fo 12 weeks.

What is being measured

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

  1. Change of maximal oxygen uptake during exercise

    ml/kg/min

    Measured: 3 months

Secondary outcomes (8)

  1. Change of flow-mediated dilatation (FMD) of the brachial artery

    % flow-mediated dilatation and arterial stiffness

    Measured: 3 months

  2. Change of arterial stiffness coefficient

    coefficient

    Measured: 3 months

  3. Change of value of blood N terminal-proBNP

    ng/l

    Measured: 3 months

  4. Change of value of blood D-dimer

    microg/l

    Measured: 3 months

  5. Change of value from-the-questionnaire-obtained quality of life

    points

    Measured: 3 months

  6. Change of ECG waves

    Estimated with digital high-resolution ECG

    Measured: 3 months

  7. Change in the result of the 6-minute walking test

    metres

    Measured: 3 months

  8. Change og the heart rate variability

    Estimated with digital high-resolution ECG

    Measured: 3 months

Timeline

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

  1. First posted29 May 2019
  2. Study start18 Jun 2019
  3. Primary completion1 Oct 2020
  4. Study completion1 Dec 2020

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03966417
Sponsor's protocol ID
UKCLFitTAVI
Acronym
FitTAVI
Status last verified
Oct 2022
First submitted
25 May 2019
Last updated
1 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chakos A, Wilson-Smith A, Arora S, Nguyen TC, Dhoble A, Tarantini G, Thielmann M, Vavalle JP, Wendt D, Yan TD, Tian DH. Long term outcomes of transcatheter aortic valve implantation (TAVI): a systematic review of 5-year survival and beyond. Ann Cardiothorac Surg. 2017 Sep;6(5):432-443. doi: 10.21037/acs.2017.09.10.

    PubMed 29062738

  • Pressler A, Christle JW, Lechner B, Grabs V, Haller B, Hettich I, Jochheim D, Mehilli J, Lange R, Bleiziffer S, Halle M. Exercise training improves exercise capacity and quality of life after transcatheter aortic valve implantation: A randomized pilot trial. Am Heart J. 2016 Dec;182:44-53. doi: 10.1016/j.ahj.2016.08.007. Epub 2016 Aug 26.

    PubMed 27914499

  • Dalal HM, Doherty P, Taylor RS. Cardiac rehabilitation. BMJ. 2015 Sep 29;351:h5000. doi: 10.1136/bmj.h5000. No abstract available.

    PubMed 26419744

  • McMahon SR, Ades PA, Thompson PD. The role of cardiac rehabilitation in patients with heart disease. Trends Cardiovasc Med. 2017 Aug;27(6):420-425. doi: 10.1016/j.tcm.2017.02.005. Epub 2017 Feb 15.

    PubMed 28318815

  • Butchart EG, Gohlke-Barwolf C, Antunes MJ, Tornos P, De Caterina R, Cormier B, Prendergast B, Iung B, Bjornstad H, Leport C, Hall RJ, Vahanian A; Working Groups on Valvular Heart Disease, Thrombosis, and Cardiac Rehabilitation and Exercise Physiology, European Society of Cardiology. Recommendations for the management of patients after heart valve surgery. Eur Heart J. 2005 Nov;26(22):2463-71. doi: 10.1093/eurheartj/ehi426. Epub 2005 Aug 15.

    PubMed 16103039

  • Voller H, Salzwedel A, Nitardy A, Buhlert H, Treszl A, Wegscheider K. Effect of cardiac rehabilitation on functional and emotional status in patients after transcatheter aortic-valve implantation. Eur J Prev Cardiol. 2015 May;22(5):568-74. doi: 10.1177/2047487314526072. Epub 2014 Feb 27.

    PubMed 24577878

  • Russo N, Compostella L, Tarantini G, Setzu T, Napodano M, Bottio T, D'Onofrio A, Isabella G, Gerosa G, Iliceto S, Bellotto F. Cardiac rehabilitation after transcatheter versus surgical prosthetic valve implantation for aortic stenosis in the elderly. Eur J Prev Cardiol. 2014 Nov;21(11):1341-8. doi: 10.1177/2047487313494029. Epub 2013 Jun 11.

    PubMed 23757283

  • Abraham LN, Sibilitz KL, Berg SK, Tang LH, Risom SS, Lindschou J, Taylor RS, Borregaard B, Zwisler AD. Exercise-based cardiac rehabilitation for adults after heart valve surgery. Cochrane Database Syst Rev. 2021 May 7;5(5):CD010876. doi: 10.1002/14651858.CD010876.pub3.

    PubMed 33962483

Questions about this trial

What is this clinical trial studying?

A study testing Exercise training in people with Aortic Valve Stenosis and TAVI, run by University Medical Centre Ljubljana at 1 site in Slovenia.

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 6 inclusion and 9 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: finished, as of the sponsor's last update on 1 Nov 2022. 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 Slovenia. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of maximal oxygen uptake during exercise (time frame: 3 months). 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 NCT03966417, which also lists 8 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 1 Nov 2022.

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