Management of Fluid Overload in TAVR

Volume Overload Clinical Trial

— EASE-TAVR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04556123
• Other study ID #: 2074/2019
• Status: Completed
• Phase: N/A
• Start date: September 13, 2020
• Est. completion date: April 1, 2023

Study information

• Verified date: July 2023
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 232
• Est. completion date: April 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Volume Overload

Intervention

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.
• 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

Locations

Country	Name	City	State
Austria	Karl Landsteiner University	St.Pölten	Niederösterreich
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Nutr Clin Pract. 2015 Aug;30(4):589. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline to 12 months in quantitative fluid levels		3 and 12 months following TAVR
Other	Change from baseline to 12 months in NT-proBNP levels		3 and 12 months following TAVR
Other	Change from baseline to 12 months in eGFR values		3 and 12 months following TAVR
Primary	Hospitalization for heart failure and/or all-cause death		3 and 12 months following TAVR
Secondary	Change from baseline to 12 months in KCCQ scores		3 and 12 months following TAVR