Fluid Status in Valvular Heart Disease

Cardiovascular Risk Factor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03371394
• Other study ID #: BCMinVHD-2439
• Status: Recruiting
• Start date: December 15, 2017
• Est. completion date: December 1, 2020

Study information

• Verified date: August 2019
• Source: Medical University of Vienna
• Contact: Andreas Kammerlander, MD
• Phone: 004314040046140
• Email: andreas.kammerlander[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Fluid Overload
• Heart Diseases
• Heart Valve Diseases
• Valvular Heart Disease

Intervention

Other:
• no intervention
no intervention

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular outcome	composition of hospitalization due to heart failure and cardiovascular death	3 years
Secondary	Severity of valvular heart disease	BCM and association with valvular severity assessed using integrated approach to current guidelines for valvular heart disease	baseline
Secondary	NT-proBNP	BCM and association with NT-proBNP	baseline
Secondary	Clinical status (NYHA functional class)	BCM and association with NYHA functional class	baseline
Secondary	Renal impairment	BCM and association with renal impariment (eGFR)	baseline