Clinical trial NCT03371394: Fluid Status in Valvular Heart Disease
Official title: Body Composition Monitoring in Valvular Heart Disease: Association With Clinical Status and Impact on Prognosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Valvular Heart Disease
Fluid Overload
Cardiovascular Risk Factor
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2017-12-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients Valvular stenosis and/or regurgitation of all severities assessed by current recommendations are eligible for this study.

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

Eligibility criteria: 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

Primary outcomes:
measure: Cardiovascular outcome
timeFrame: 3 years
Secondary outcomes:
measure: Severity of valvular heart disease
timeFrame: baseline
measure: NT-proBNP
timeFrame: baseline
measure: Clinical status (NYHA functional class)
timeFrame: baseline
measure: Renal impairment
timeFrame: baseline
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References: