Exercise Training After Transcatheter Aortic Valve Implantation (FitTAVI)

October 31, 2022 updated by: Borut Jug, University Medical Centre Ljubljana
In this prospective, controlled trial, patient after TAVI will be randomized to either exercise training or usual care group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • UMC Ljubljana

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 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Exercise training group
Patient 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.
Other: Exercise training
Continuous exercise training 2 times per week for a period of 12 weeks.
Other Names:
  • Rehabilitation
No Intervention: Usual care group
Patient to be randomized to "usual care group" will undergo standard care fo 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of maximal oxygen uptake during exercise
Time Frame: 3 months
ml/kg/min
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of flow-mediated dilatation (FMD) of the brachial artery
Time Frame: 3 months
% flow-mediated dilatation and arterial stiffness
3 months
Change of arterial stiffness coefficient
Time Frame: 3 months
coefficient
3 months
Change of value of blood N terminal-proBNP
Time Frame: 3 months
ng/l
3 months
Change of value of blood D-dimer
Time Frame: 3 months
microg/l
3 months
Change of value from-the-questionnaire-obtained quality of life
Time Frame: 3 months
points
3 months
Change of ECG waves
Time Frame: 3 months
Estimated with digital high-resolution ECG
3 months
Change in the result of the 6-minute walking test
Time Frame: 3 months
metres
3 months
Change og the heart rate variability
Time Frame: 3 months
Estimated with digital high-resolution ECG
3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of heart rate recovery
Time Frame: 3 months
beats/min
3 months

Collaborators and Investigators

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

Sponsor

University Medical Centre Ljubljana

Investigators

  • Principal Investigator: Borut Jug, MD, PhD, University Medical Centre Ljubljana, Slovenia

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)

June 18, 2019

Primary Completion (Actual)

October 1, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

May 25, 2019

First Submitted That Met QC Criteria

May 25, 2019

First Posted (Actual)

May 29, 2019

Study Record Updates

Last Update Posted (Actual)

November 1, 2022

Last Update Submitted That Met QC Criteria

October 31, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UKCLFitTAVI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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