Fluid Status in Valvular Heart Disease

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

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

Study Overview

• Status: Unknown
• Conditions: Fluid Overload; Cardiovascular Risk Factor; Valvular Heart Disease
• Intervention / Treatment: Other: no intervention

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • Medical University of Vienna
    • Contact: Andreas Kammerlander, MD PhD; Phone Number: 004314040046140; Email: andreas.kammerlander@meduniwien.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients Valvular stenosis and/or regurgitation of all severities assessed by current recommendations are eligible for this study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
median 1	Other: no intervention; no intervention
median 2	Other: no intervention; no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular outcome	composition of hospitalization due to heart failure and cardiovascular death	3 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2017
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: December 7, 2017
• First Submitted That Met QC Criteria: December 7, 2017
• First Posted (Actual): December 13, 2017

Study Record Updates

• Last Update Posted (Actual): August 14, 2019
• Last Update Submitted That Met QC Criteria: August 12, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases
• Other Study ID Numbers: BCMinVHD-2439

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No