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Management of Fluid Overload in TAVR

NCT04556123 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 232

Last updated 2023-07-11

No results posted yet for this study

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.

Conditions

  • Volume Overload

Interventions

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.

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

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Christian Nitsche, MD · Medical University of Vienna, Dpt. of Cardiology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-13
Primary Completion
2023-04-01
Completion
2023-04-01

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04556123 on ClinicalTrials.gov