Fluid Status in Valvular Heart Disease

Medical University of Vienna

Status: Unknown

Conditions: Valvular Heart Disease; Cardiovascular Risk Factor; Fluid Overload

Treatments: Other: no intervention

Study type: Observational

Funder types: Other

Identifiers

NCT03371394

BCMinVHD-2439

Details and patient eligibility

About

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

Full 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

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

median 1

Treatment:

Other: no intervention

median 2

Treatment:

Other: no intervention