Management of Fluid Overload in TAVR (EASE-TAVR)

July 8, 2023 updated by: Christian Nitsche, Medical University of Vienna

Bioimpedance Guided Management of Patients Scheduled for Transcatheter Aortic Valve Replacement: A Randomized Controlled Trial.

Fluid overload (FO) puts aortic stenosis (AS) patients at risk for heart failure and death. However, conventional FO assessment, including rapid weight gain, peripheral edema, or chest radiography, is inaccurate. Bioelectrical impedance spectroscopy (BIS) allows objective and reproducible FO quantification, particularly if clinically unapparent. FO as detected with BIS has recently been linked to worse clinical outcomes of AS patients undergoing transcatheter aortic valve replacement (TAVR).

It is the aim of the present randomised trial to evaluate the potential clinical benefit of pursuing an individualized decongestion treatment strategy in consecutive TAVR patients using BIS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a randomized controlled trial investigating the effect of BIS-guided decongestive treatment on clinical outcomes in overhydrated patients scheduled for and receiving TAVR.

Centers participating in this trial are: Medical University of Vienna, Kepler University Hospital Linz

Consecutive adult patients with severe degenerative AS scheduled for TAVR will be prospectively enrolled at university-affiliated tertiary centers in Austria. Eligibility and decision for TAVR will be determined by a multidisciplinary Heart Team. All patients who are willing to participate will undergo assessment of volume status using BIS prior to intervention. Overhydrated subjects, defined as a relative fluid overload ≥7% (Rel. FO = fluid overload/extracellular water × 100%) and/or absolute fluid overload ≥1L as assessed by BIS, will then be randomly assigned to undergo BIS-guided pre- and postprocedural decongestion treatment vs. decongestion treatment based on mere clinical judgement of volume status in a 1:1 fashion. In order to avoid detection bias, FO patients in the non-BIS group as well as their treating physicians shall be blinded for BIS-results. Physicians and study participants will only be informed about the targeted dry body weight, if randomized to the BIS-guided decongestion group. Decongestion will be performed using standard medication (e.g. loop diuretics) and applied orally or intravenously, as appropriate. After TAVR, patients with FO will be followed before discharge from the hospital, after 3, 6 and 12 months.

Methods:

Patients will undergo standardized evaluation of their fluid status using a portable whole-body BIS device, the Body Composition Monitor (BCM, Fresenius Medical Care, Bad Homburg, Germany). Patients will be placed in supine position before the evaluation of their fluid status. Electrodes will be attached to the nondominant hand and the ipsilateral foot. Measurements will be conducted according to the manufacturer's manual. For each patient, only one bioelectrical impedance analysis will be performed, as this method has an adequate reproducibility. Fluid overload assessed by BCM is expressed as an absolute value in liters or as a relative value in %, calculated as the ratio between fluid overload (FO) and the content of extracellular water (ECW) and multiplied by 100 (Rel. FO = FO/ECW × 100%).

Prespecified study visits:

V0 (14+-13 days prior to TAVR): BIS measurement, pitting edema quantification, demographic factors, symptom assessment, cardiovascular risk factors, ECG, laboratory analysis (e.g. NT-pro BNP, hs-TnT), frailty assessment, KCCQ questionnaire, transthoracic echocardiography; V1 (90+-7 days post TAVR): BIS measurement, pitting edema quantification, demographic factors, symptom assessment, ECG, laboratory analysis (e.g. NT-pro BNP, hs-TnT), KCCQ questionnaire, transthoracic echocardiography; TV2 (telephone visit, 180+-7 days post TAVR): demographic factors, symptom assessment; V3 (360+-7 days post TAVR, =end of treatment): BIS measurement, pitting edema quantification, demographic factors, symptom assessment, ECG, laboratory analysis (e.g. NT-pro BNP, hs-TnT), KCCQ questionnaire, transthoracic echocardiography;

Outcome:

Cardiac outcomes (see below) will be assessed at 3 months (=prespecified interim analysis), and 12 months follwing TAVR.

Study Type

Interventional

Enrollment (Actual)

232

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

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna
    • Niederösterreich
      • St.Pölten, Niederösterreich, Austria, 3100
        • Karl Landsteiner University

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Written informed consent
  • Age ≥18 years
  • Scheduled TAVR for the treatment of severe aortic stenosis
  • Fluid overlaod ≥7% and/or ≥1L by BIS prior to TAVR (necessary to undergo randomization process)

Exclusion Criteria:

  • Unwillingness or inability to participate
  • Pregnancy
  • Chronic dialysis
  • Severe electrolyte disorders

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fluid overload: BIS-guided decongestion
Other: Measurement of the hydration state and decongestive treatment according to bioimpedance spectroscopy

The measurements will be performed in each center by a reference physician or nurse, using a portable whole body bioimpedance spectroscopy device, BCM (Fresenius Medical Care).

The electrodes will be attached to one hand and one foot on the ipsilateral side, after the patient has been in the supine position for at least 5 minutes.
Active Comparator: Fluid overload: Decongestion based on clinical judgement
Other: Measurement of the hydration state and decongestive treatment according to clinical judgement alone
Clinical judgement will be performed in each center by a reference physician or nurse
No Intervention: No fluid overload: standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hospitalization for heart failure and/or all-cause death
Time Frame: 3 and 12 months following TAVR
3 and 12 months following TAVR

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline to 12 months in KCCQ scores
Time Frame: 3 and 12 months following TAVR
3 and 12 months following TAVR

Other Outcome Measures

Outcome Measure
Time Frame
Change from baseline to 12 months in quantitative fluid levels
Time Frame: 3 and 12 months following TAVR
3 and 12 months following TAVR
Change from baseline to 12 months in NT-proBNP levels
Time Frame: 3 and 12 months following TAVR
3 and 12 months following TAVR
Change from baseline to 12 months in eGFR values
Time Frame: 3 and 12 months following TAVR
3 and 12 months following TAVR

Collaborators and Investigators

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

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Christian Nitsche, MD, Medical University of Vienna, Dpt. of Cardiology

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)

September 13, 2020

Primary Completion (Actual)

April 1, 2023

Study Completion (Actual)

April 1, 2023

Study Registration Dates

First Submitted

September 8, 2020

First Submitted That Met QC Criteria

September 14, 2020

First Posted (Actual)

September 21, 2020

Study Record Updates

Last Update Posted (Actual)

July 11, 2023

Last Update Submitted That Met QC Criteria

July 8, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2074/2019

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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