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EASE-TAVR: Management of Fluid Overload in TAVR

Sponsor
Medical University of Vienna (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04556123
Collaborator
(none)
108
Enrollment
2
Locations
2
Arms
27.6
Anticipated Duration (Months)
54
Patients Per Site
2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Measurement of the hydration state and decongestive treatment according to bioimpedance spectroscopy
  • Other: Measurement of the hydration state and decongestive treatment according to clinical judgement alone
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
108 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Masking Description:
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.
Primary Purpose:
Treatment
Official Title:
Bioimpedance Guided Management of Patients Scheduled for Transcatheter Aortic Valve Replacement: A Randomized Controlled Trial.
Actual Study Start Date :
Sep 13, 2020
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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: 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

Outcome Measures

Primary Outcome Measures

  1. Hospitalization for heart failure and/or all-cause death [3 and 12 months following TAVR]

Secondary Outcome Measures

  1. Acute kidney injury [within 7 days post-TAVR]

  2. Permanent pacemaker implantation [within 7 days and 1 month post-TAVR]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Karl Landsteiner University St.Pölten Niederösterreich Austria 3100
2 Medical University of Vienna Vienna Austria 1090

Sponsors and Collaborators

  • Medical University of Vienna

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Christian Nitsche, MD, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT04556123
Other Study ID Numbers:
  • 2074/2019
First Posted:
Sep 21, 2020
Last Update Posted:
Feb 25, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Christian Nitsche, MD, Medical University of Vienna
fluid overload
TAVR
decongestion
bioimpedance spectroscopy

Study Results

No Results Posted as of Feb 25, 2022