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Completed

NCT Number: NCT03966417

Exercise Training After Transcatheter Aortic Valve Implantation

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

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UMC Ljubljana

Ljubljana, 1000, Slovenia

About this study

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:

  • exercise capacity
  • vascular function
  • parameters of heart failure, inflammation and homeostasis
  • arrhythmogenic potential
  • health-related quality of life

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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),
  • 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.

Treatment and study plan

Exercise training

Other

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

Other names: Rehabilitation

Primary outcomes

  1. Change of maximal oxygen uptake during exercise

    Time frame: 3 months

    ml/kg/min

Secondary outcomes

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

    Time frame: 3 months

    % flow-mediated dilatation and arterial stiffness

  2. Change of arterial stiffness coefficient

    Time frame: 3 months

    coefficient

  3. Change of value of blood N terminal-proBNP

    Time frame: 3 months

    ng/l

  4. Change of value of blood D-dimer

    Time frame: 3 months

    microg/l

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

    Time frame: 3 months

    points

  6. Change of ECG waves

    Time frame: 3 months

    Estimated with digital high-resolution ECG

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

    Time frame: 3 months

    metres

  8. Change og the heart rate variability

    Time frame: 3 months

    Estimated with digital high-resolution ECG

Other outcomes

  1. Change of heart rate recovery

    Time frame: 3 months

    beats/min

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Acronym: FitTAVI

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 29, 2019
Registry last updated
Nov 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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