The Role of Bioimpedance Analysis in Patients With Chronic Heart Failure and Systolic Ventricular Dysfunction

NCT05631275 | Unknown

• 1 other identifier: PIC003-20_FJD
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Heart failure (HF) represents a major problem in today's health care landscape and is expected to grow in the next years due to an aging population and improved treatments. In many cases, the evaluation of the volemia status of patients with left ventricular dysfunction is not easy in the outpatient setting, due to limitations of physical examination in stable patients, as well as the tolerance to chronic HF they have. The aim of this study is to determine whether the bioelectrical impedance analysis (BIA) is useful in determining the real clinical stability of chronic HF, its potential implications for clinical management and patient follow-up, as well as for the adjustment of pharmacological treatment. This study is observational, single-center, single-blind and outpatient. It includes patients with a previous diagnosis of HF and left ventricular ejection fraction (LVEF) ≤ 40%, who are stable at the time of inclusion. Follow-up is estimated to be 12 months.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Patients Volemia status

  determine the volemia status of the patients with the BIA parameters

  15 minutes

Eligibility Criteria

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

Study Population

The study population is outpatients attended at cardiology consultations of the Hospital Universitario Fundación Jiménez Díaz, with a diagnosis of stable HF (without admission due to decompensation or first episode of HF in the previous year) and with a LVEF ≤ 40%

You may qualify if:

• \- Outpatients attended at cardiology consultations of the Hospital Universitario Fundación Jiménez Díaz, with a diagnosis of stable HF and with a LVEF ≤ 40%.

You may not qualify if:

• admission due to decompensation or first episode of HF in the previous year
• amputated patients
• Chronic treatment with corticosteroids
• Pregnancy and breastfeeding
• Any clinically significant condition detected at the time of screening that in the opinion of the investigators may impair the safe completion of the study or limit the evaluation of the endpoints.
• Patients who are actively participating in clinical trials other than observational trials.

Sponsors & Collaborators

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

Study Sites (1)

Fundación Jiménez Dia University Hospital, IIS-FJD

Madrid, 28040, Spain

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Hans Gaebelt, MD, PhD

  Fundación Jiménez Dia University Hospital, IIS-FJD

  STUDY DIRECTOR

Central Study Contacts

Rocío Carda, MD, PhD

CONTACT

+34915504800; rcarda@fjd.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MhD, PhD

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: November 30, 2022
• Study Start: September 7, 2022
• Primary Completion: December 7, 2022
• Study Completion: September 7, 2023
• Last Updated: March 2, 2023

Record last verified: 2023-03

Locations

ES (1)