Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

Endpoints: The primary end-point is to determine the volemia status of the patients and whether there is a correlation between clinical and analytical parameters and those determined with the BIA. It will also be correlated with the clinical questionnaire (ICEBERG). Secondary objectives: to analyze whether the data obtained with BIA correlate with heart failure events such as hospitalization, change in the functional class of patients, worsening renal function, need for changes in medical treatment or implantation of intracardiac devices. In addition, if data allows it, we will evaluate the relationship with quality of life, cardiovascular mortality, changes in biomarkers (NT-ProBNP (N-terminal pro-B-type natriuretic peptide), Troponin I...), and cost-effectiveness. Design: This study was design as a single-center observational study in which patients undergoing to a cardiology consultation were selected and underwent bioimpedance measurement as well as a clinical questionnaire. The aim is to obtain data that will help the execution of a larger study about a broadly use of BIA in the management of HF in the future. This study was approved by an institutional review committee and performed under Helsinki Declaration Guidelines. All patients signed the informed consent before entering the study. 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% will be included. We estimate that approximately 100 patients can be included in a 3-month inclusion period. Study procedures: The variables collected are general medical data, analytical data, including the cardiac biomarker NT-proBNP and answers to the ICEBERG questionnaire. BIA is performed when the patient is included in the study. For follow-up, a review of the clinical history will be carried out in the next months, including a phone contact with the patient if necessary, to obtain information related to mortality or hospital care due to chronic HF. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05631275
Study type Observational [Patient Registry]
Source Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Contact Rocío Carda, MD, PhD
Phone +34915504800
Email rcarda@fjd.es
Status Recruiting
Phase
Start date September 7, 2022
Completion date September 7, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT05196659 - Collaborative Quality Improvement (C-QIP) Study N/A
Recruiting NCT05654272 - Development of CIRC Technologies
Recruiting NCT05650307 - CV Imaging of Metabolic Interventions
Active, not recruiting NCT05896904 - Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction N/A
Completed NCT05077293 - Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
Enrolling by invitation NCT05564572 - Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology N/A
Enrolling by invitation NCT05009706 - Self-care in Older Frail Persons With Heart Failure Intervention N/A
Recruiting NCT04177199 - What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
Terminated NCT03615469 - Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY) N/A
Recruiting NCT06340048 - Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure Phase 1/Phase 2
Recruiting NCT05679713 - Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
Completed NCT04254328 - The Effectiveness of Nintendo Wii Fit and Inspiratory Muscle Training in Older Patients With Heart Failure N/A
Completed NCT03549169 - Decision Making for the Management the Symptoms in Adults of Heart Failure N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Enrolling by invitation NCT05538611 - Effect Evaluation of Chain Quality Control Management on Patients With Heart Failure
Recruiting NCT04262830 - Cancer Therapy Effects on the Heart
Completed NCT06026683 - Conduction System Stimulation to Avoid Left Ventricle Dysfunction N/A
Withdrawn NCT03091998 - Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support Phase 1
Recruiting NCT05564689 - Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy
Completed NCT04549181 - Problem-Solving for Rural Heart Failure Dyads N/A