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Bioimpedance in Overweight and Obese Patients With Acute Heart Failure

NCT05541068 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2022-09-15

No results posted yet for this study

Summary

Patients with heart failure (HF) have poor prognosis with high mortality and readmission rates. Diuretic therapy is the usual way of managing congestion, but sometimes is difficult to determine when we have reached euvolemia. Even in overweight and obese patients in which physical examination and usual diagnostic techniques have strong limitations. The aim of this study is to investigate the usefulness of bioelectrical impedance analysis (BIA) in management and treatment of HF in overweight and obese patients.

The study included overweight and obese patients who were admitted with acute decompensated HF. The study population was randomized into two arms: BIA-guided therapy or standard care. Serum electrolytes, kidney functions and natriuretic peptides were followed up during their hospital stay and at 90 days after discharge.

The primary endpoint was development of acute kidney injury (AKI) stage III (AKIN-III) during hospitalization and the main secondary endpoint was the reduction of NT-proBNP (N-terminal pro-B-type natriuretic peptide) levels during hospitalization and within 90 days after discharge.

Conditions

Interventions

DEVICE

Bioimpedance analysis

Bioimpedance analysis to achieve assessments of fluid status, especially dry-weight, was performed with the portable Biomasc touch i8 (MaltronInternationl, Essex, UK).

Sponsors & Collaborators

  • Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

    lead OTHER

Principal Investigators

  • Ana Maria Pello, MD, PhD · Fundacion Jimenez Diaz University Hospital, IIS-FJD

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-26
Primary Completion
2021-12-29
Completion
2022-03-29

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05541068 on ClinicalTrials.gov