Bioimpedance in Overweight and Obese Patients With Acute Heart Failure

NCT05541068 | Completed

• 1 other identifier: PIC172-19_FJD
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Development of acute kidney injury

  Rate of patients with acute kidney injury (AKI) during hospitalization, defined as an increase in serum creatinine by \>0.5 mg/dL (AKIN classification stage III)

  Through hospitalization, an average of 7 days

Secondary Outcomes (4)

• levels of NT-proBNP levels <1.000 pg/mL

  90 days after discharge.

• Length of stay in hospital.

  Through hospitalization, an average of 7 days

• NT-proBNP reduction >30% during hospitalization

  Through hospitalization, an average of 7 days

• The combined endpoint of all-cause death, rehospitalization for HF or visit to the ED because of congestion symptoms measured at 90 days after discharge

  90 days after discharge.

Study Arms (2)

Guided by bioimpedance analysis

ACTIVE COMPARATOR

These patients were discharged when dry-weight was achieved according to BIA measurements if there was none clinical condition which justified the hospitalization.

Device: Bioimpedance analysis

Control arm

ACTIVE COMPARATOR

In those patients, BIA parameters were not known by the physician responsible. These patients were discharged when they achieved the euvolemic state based in the criteria of their physician

Device: Bioimpedance analysis

Interventions

Bioimpedance analysis DEVICE

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

Control arm; Guided by bioimpedance analysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalized for Acute Heart Failure (first episode or decompensation), based on Framingham criteria and NT-ProBNP\>300 pg/ml
• Body mass index greater than or equal to 25 kg/m2 at admission.

You may not qualify if:

• Hemodynamic instability,
• Chronic kidney disease with estimated glomerular filtration rate (eGFR) \<15 ml/min/1.73m2, Pregnancy,
• Amputated patients,
• Chronic treatment with corticosteroids,
• Severe valvular heart disease with indication for intervention,
• Dementia or life-expectancy of 1 year or less with high probability for noncompliance with the study protocol.

Sponsors & Collaborators

• Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz: lead

Study Sites (1)

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Ana Maria Pello, MD, PhD

  Fundacion Jimenez Diaz University Hospital, IIS-FJD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: September 15, 2022
• Study Start: February 26, 2020
• Primary Completion: December 29, 2021
• Study Completion: March 29, 2022
• Last Updated: September 15, 2022

Record last verified: 2022-09

Locations

ES (1)