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Clinical Trials/NCT03371394
NCT03371394
Unknown
Not Applicable

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

Medical University of Vienna1 site in 1 country200 target enrollmentDecember 15, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Valvular Heart Disease
Sponsor
Medical University of Vienna
Enrollment
200
Locations
1
Primary Endpoint
Cardiovascular outcome
Last Updated
6 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
December 15, 2017
End Date
December 1, 2020
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Andreas Kammerlander

MD

Medical University of Vienna

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

Outcomes

Primary Outcomes

Cardiovascular outcome

Time Frame: 3 years

composition of hospitalization due to heart failure and cardiovascular death

Secondary Outcomes

  • Severity of valvular heart disease(baseline)
  • Clinical status (NYHA functional class)(baseline)
  • NT-proBNP(baseline)
  • Renal impairment(baseline)

Study Sites (1)

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