Management of Fluid Overload in TAVR

NCT04556123 | Completed

• 1 other identifier: 2074/2019
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 2

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.

Conditions

Volume Overload

Keywords

fluid overload; TAVR; decongestion; bioimpedance spectroscopy

Outcome Measures

Primary Outcomes (1)

• Hospitalization for heart failure and/or all-cause death

  3 and 12 months following TAVR

Secondary Outcomes (1)

• Change from baseline to 12 months in KCCQ scores

  3 and 12 months following TAVR

Other Outcomes (3)

• Change from baseline to 12 months in quantitative fluid levels

  3 and 12 months following TAVR

• Change from baseline to 12 months in NT-proBNP levels

  3 and 12 months following TAVR

• Change from baseline to 12 months in eGFR values

  3 and 12 months following TAVR

Study Arms (3)

Fluid overload: BIS-guided decongestion

EXPERIMENTAL

Other: Measurement of the hydration state and decongestive treatment according to bioimpedance spectroscopy

Fluid overload: Decongestion based on clinical judgement

ACTIVE COMPARATOR

Other: Measurement of the hydration state and decongestive treatment according to clinical judgement alone

No fluid overload: standard of care

NO INTERVENTION

Interventions

Measurement of the hydration state and decongestive treatment according to bioimpedance spectroscopy OTHER

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.

Fluid overload: BIS-guided decongestion

Measurement of the hydration state and decongestive treatment according to clinical judgement alone OTHER

Clinical judgement will be performed in each center by a reference physician or nurse

Fluid overload: Decongestion based on clinical judgement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (2)

Karl Landsteiner University

Sankt Pölten, Lower Austria, 3100, Austria

Location

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (9)

• Hong YA, Yoon HE, Choi BS, Shin SJ, Kim YS, Lee SY, Lee SH, Kim SH, Lee EY, Shin SK, Kwon YJ, Kim JH, Chang YK, Kim SY, Kim JE, Ahn SY, Ko GJ. The Effect of Strict Volume Control Assessed by Repeated Bioimpedance Spectroscopy on Cardiac Function in Peritoneal Dialysis Patients. Sci Rep. 2019 Nov 27;9(1):17679. doi: 10.1038/s41598-019-53792-0.

  PMID: 31776362 BACKGROUND

• Machek P, Jirka T, Moissl U, Chamney P, Wabel P. Guided optimization of fluid status in haemodialysis patients. Nephrol Dial Transplant. 2010 Feb;25(2):538-44. doi: 10.1093/ndt/gfp487. Epub 2009 Sep 30.

  PMID: 19793930 BACKGROUND

• Hur E, Usta M, Toz H, Asci G, Wabel P, Kahvecioglu S, Kayikcioglu M, Demirci MS, Ozkahya M, Duman S, Ok E. Effect of fluid management guided by bioimpedance spectroscopy on cardiovascular parameters in hemodialysis patients: a randomized controlled trial. Am J Kidney Dis. 2013 Jun;61(6):957-65. doi: 10.1053/j.ajkd.2012.12.017. Epub 2013 Feb 15.

  PMID: 23415416 BACKGROUND

• Koell B, Zotter-Tufaro C, Duca F, Kammerlander AA, Aschauer S, Dalos D, Antlanger M, Hecking M, Saemann M, Mascherbauer J, Bonderman D. Fluid status and outcome in patients with heart failure and preserved ejection fraction. Int J Cardiol. 2017 Mar 1;230:476-481. doi: 10.1016/j.ijcard.2016.12.080. Epub 2016 Dec 21.

  PMID: 28062131 BACKGROUND

• Stevenson LW, Perloff JK. The limited reliability of physical signs for estimating hemodynamics in chronic heart failure. JAMA. 1989 Feb 10;261(6):884-8.

  PMID: 2913385 BACKGROUND

• Mulasi U, Kuchnia AJ, Cole AJ, Earthman CP. Bioimpedance at the bedside: current applications, limitations, and opportunities. Nutr Clin Pract. 2015 Apr;30(2):180-93. doi: 10.1177/0884533614568155. Epub 2015 Jan 22.

  PMID: 25613832 BACKGROUND

• Nitsche C, Kammerlander AA, Koschutnik M, Sinnhuber L, Forutan N, Eidenberger A, Dona C, Schartmueller F, Dannenberg V, Winter MP, Siller-Matula J, Anvari-Pirsch A, Goliasch G, Hengstenberg C, Mascherbauer J. Fluid overload in patients undergoing TAVR: what we can learn from the nephrologists. ESC Heart Fail. 2021 Apr;8(2):1408-1416. doi: 10.1002/ehf2.13226. Epub 2021 Feb 13.

  PMID: 33580746 BACKGROUND

• Nitsche C, Kammerlander AA, Koschutnik M, Dona C, Aschauer S, Sinnhuber L, Eidenberger A, Forutan N, Schartmueller F, Andreas M, Beitzke D, Bergler-Klein J, Bartko PE, Siller-Matula J, Winter MP, Anvari-Pirsch A, Goliasch G, Hengstenberg C, Mascherbauer J. Volume Status Impacts CMR-Extracellular Volume Measurements and Outcome in AS Undergoing TAVR. JACC Cardiovasc Imaging. 2021 Feb;14(2):516-518. doi: 10.1016/j.jcmg.2020.08.010. Epub 2020 Sep 30. No abstract available.

  PMID: 33011120 BACKGROUND

• Halavina K, Koschutnik M, Dona C, Autherith M, Petric F, Rockel A, Spinka G, Danesh D, Puchinger J, Wiesholzer M, Mascherbauer K, Heitzinger G, Dannenberg V, Koschatko S, Jantsch C, Winter MP, Goliasch G, Kammerlander AA, Bartko PE, Hengstenberg C, Mascherbauer J, Nitsche C. Management of Fluid Overload in Patients With Severe Aortic Stenosis (EASE-TAVR): A Randomized Controlled Trial. JACC Cardiovasc Interv. 2024 Sep 9;17(17):2054-2066. doi: 10.1016/j.jcin.2024.06.022.

  PMID: 39260962 DERIVED

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christian Nitsche, MD

  Medical University of Vienna, Dpt. of Cardiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Consecutive patients scheduled for TAVR fulfilling inclusion criteria will be enrolled. Patients with FO will be randomized in a 1:1 fashion to either BIS-guided decongestion or decongestion as per clinical judgement alone. Patients without FO will serve as an euvolemic control cohort.

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 21, 2020
• Study Start: September 13, 2020
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: July 11, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)