Fluid Status in Valvular Heart Disease

• Conditions: Valvular Heart Disease; Fluid Overload; Cardiovascular Risk Factor
• Interventions: Other: no intervention

• Registration Number: NCT03371394
• Lead Sponsor: Medical University of Vienna

Brief Summary

By bioelectrical impedance spectroscopy (BIS) association of fluid status in patients with valvular heart disease and cardiovascular outcome will be assessed.

Detailed Description

Volume overload and abnormal fluid distribution are hallmarks in the syndromes of acute and chronic heart failure (HF) as well as valvular heart disease (VHD). Most patients, at some point in their disease progression, present acutely to an emergency department, where they will typically show symptoms of progressive volume overload.

Most patients respond well to standard diuretic therapy, usually at the costs of impaired renal function. Based on the assumption that clinically overt fluid overload is the result of progressive fluid accumulation, current European Society of Cardiology (ESC) and American College of Cardiology Foundation/American Heart Association (ACCF/AHA) guidelines recommend a correction of volume status using diuretics, to reduce the total fluid volume. However there is no consensus on how to define fluid overload quantitavely.

In patients undergoing dialysis, bioelectrical impedance spectroscopy / body composition monitoring (BCM) is a well established tool to assess fluid status, allowing quantitative measurement.

This study aims to

1. Establish a database reflecting the fluid status assessed by BCM of patients presenting with valvular heart disease according to current guidelines

2. Monitor fluid status assessed by BCM during increased diuretic treatment in patients presenting with cardiac decompensation due to valvular heart disease

3. Assess the association between severity of valvular heart disease assessed by echocardiography and/or cardiac magnetic resonance imaging, fluid status assessed by BCM, and clinical as well as laboratory parameters assessed during clinical routine

4. Assess the relationship between fluid status assessed by BCM and cardiovascular outcome

Study Timeline

• Study First Submitted: 2017-12-07
• Study First Submitted QC: 2017-12-07
• Study First Posted: 2017-12-13
• Study Start: 2017-12-15
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-12
• Last Update Posted: 2019-08-14
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Valvular stenosis and/or regurgitation of all severities as defined by current recommendations
• informed consent
• willingness to perform follow up visit

Exclusion Criteria

• <18 years old
• pregnancy
• unwillingness to paricipate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
median 2	no intervention	-
median 1	no intervention	-

Primary Outcome Measures

Name	Time	Method
Cardiovascular outcome	3 years	composition of hospitalization due to heart failure and cardiovascular death

Secondary Outcome Measures

Name	Time	Method
Severity of valvular heart disease	baseline	BCM and association with valvular severity assessed using integrated approach to current guidelines for valvular heart disease
Clinical status (NYHA functional class)	baseline	BCM and association with NYHA functional class
NT-proBNP	baseline	BCM and association with NT-proBNP
Renal impairment	baseline	BCM and association with renal impariment (eGFR)

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria