Clinical Trials Directory

Trials / Unknown

UnknownNCT03371394

Fluid Status in Valvular Heart Disease

Body Composition Monitoring in Valvular Heart Disease: Association With Clinical Status and Impact on Prognosis

Status
Unknown
Phase
Study type
Observational
Enrollment
200 (estimated)
Sponsor
Medical University of Vienna · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers

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

Conditions

Interventions

TypeNameDescription
OTHERno interventionno intervention

Timeline

Start date
2017-12-15
Primary completion
2020-12-01
Completion
2020-12-01
First posted
2017-12-13
Last updated
2019-08-14

Locations

1 site across 1 country: Austria

Source: ClinicalTrials.gov record NCT03371394. Inclusion in this directory is not an endorsement.