Bioimpedance Analysis in Chronic Heart Failure

Heart Failure Clinical Trial

Official title:

Role of the Bioimpedance Analysis in Guiding the Diuretic Therapy in Chronic Heart Failure - A Randomized Controlled Trial

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02662439
• Other study ID #: HF-BCM-15-1
• Status: Suspended
• Phase: N/A
• First received: January 14, 2016
• Last updated: May 31, 2017
• Start date: February 2016

Study information

• Verified date: May 2017
• Source: Semmelweis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to investigate whether the objective measurement of fluid overload by bioimpedance analysis (Body Composition Monitor-BCM) in patient with acute decompensated heart failure would improve the diuretic therapy.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 240
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with known or newly discovered chronic heart failure admitted to hospital because of the clinical signs of acut cardiac decompensation

Exclusion Criteria:

• High level of fatigue (the patient cannot stand on a scale)

• Amputated upper and/or lower limb(s)

• The BCM analysis is not possible technically (e.g. open wounds on the limbs)

• Severe obesity (>130 kg)

• Patients on chronic hemodialysis or peritoneal dialysis

• Severe fluid volume in the transcellular space

• Patients with a unipolar pacemaker whose sensitivity threshold is very low

• Pregnancy, lactation

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Body Composition Monitor (BCM)
In the experimental group, the diuretic therapy adjusted according to the result of the BCM analysis.

Locations

Country	Name	City	State
Hungary	First Department of Medicine, Semmelweis University	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Peter Studinger

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of life	Measured by validated questionnaire	3 months
Other	Renal function decline	Measured by estimated glomerular filtration rate (ml/min/1.73m2)	3 months
Primary	Re-hospitalization rate		12 months
Secondary	All cause mortality		12 months