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Fluid Status in Valvular Heart Disease

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03371394
Enrollment
200
Registered
2017-12-13
Start date
2017-12-15
Completion date
2020-12-01
Last updated
2019-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Risk Factor, Fluid Overload, Valvular Heart Disease

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

Interventions

OTHERno intervention

no intervention

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Cardiovascular outcome3 yearscomposition of hospitalization due to heart failure and cardiovascular death

Secondary

MeasureTime frameDescription
Severity of valvular heart diseasebaselineBCM and association with valvular severity assessed using integrated approach to current guidelines for valvular heart disease
NT-proBNPbaselineBCM and association with NT-proBNP
Clinical status (NYHA functional class)baselineBCM and association with NYHA functional class
Renal impairmentbaselineBCM and association with renal impariment (eGFR)

Countries

Austria

Contacts

Primary ContactAndreas Kammerlander, MD
andreas.kammerlander@meduniwien.ac.at004314040046140

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026