Fluid Status in Valvular Heart Disease

Status Recruiting

Clinical Trial Summary

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

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03371394
Study type	Observational [Patient Registry]
Source	Medical University of Vienna
Contact	Andreas Kammerlander, MD
Phone	004314040046140
Email	andreas.kammerlander@meduniwien.ac.at
Status	Recruiting
Phase
Start date	December 15, 2017
Completion date	December 1, 2020

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03644524` - Heat Therapy and Cardiometabolic Health in Obese Women	N/A
Enrolling by invitation	`NCT04253054` - Chinese Multi-provincial Cohort Study-Beijing Project
Completed	`NCT03680638` - The Effect of Antioxidants on Skin Blood Flow During Local Heating	Phase 1
Recruiting	`NCT04481503` - Transthoracic Echocardiography of Ventricular Function of Parturients in Labor
Terminated	`NCT04088240` - Effects of Omega-3 Docosapentaenoic Acid on Lipids and Other Risk Factors for Cardiovascular Disease	N/A
Completed	`NCT03410342` - The Effects of Types of Fruits and Vegetables on Vascular Function	N/A
Completed	`NCT03170752` - Implementing and Testing a Cardiovascular Assessment Screening Program (CASP)	N/A
Recruiting	`NCT04231838` - Metabolic Syndrome in Diabetic Smokers Using Cigarettes & Combustion-Free Nicotine Delivery Systems	N/A
Active, not recruiting	`NCT03902431` - Translating the ABCS Into HIV Care	N/A
Terminated	`NCT03517111` - The Impact of a Parenting Intervention on Latino Youth Health Behaviors	N/A
Completed	`NCT04562467` - The Use of Icosapent Ethyl on Vascular Progenitor Cells in Individuals With Elevated Cardiovascular Risk	Phase 4
Completed	`NCT03429920` - Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors	N/A
Completed	`NCT04551872` - RESILIENCE: Personalizing Cardiovascular Health	N/A
Enrolling by invitation	`NCT03314818` - Natural History of Carotid Plaque as Determined by 3D Ultrasound	N/A
Completed	`NCT03060811` - Mediterranean Diet, Trimethylamine N-oxide (TMAO) and Anti-oxidants in Healthy Adults	N/A
Completed	`NCT04279704` - Overcoming Obstacles in Epigenetic Analysis of Human Twins
Completed	`NCT01050205` - The Healthy Lifestyle Project	N/A
Completed	`NCT03570840` - Pediatric Metabolic Syndrome Study
Completed	`NCT03039023` - Effects of Choline From Eggs vs. Supplements on the Generation of TMAO in Humans	N/A
Completed	`NCT04353700` - Effects of a 12-week Home-based Yoga on Bone and Cardiovascular Health	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.