Heart FailureNCT05631275
The Role of Bioimpedance Analysis in Patients With Chronic Heart Failure and Systolic Ventricular Dysfunction
An observational study of Heart Failure, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 7 Sep 2022to 7 Sep 2023
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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%
Who may be able to join
- Outpatients attended at cardiology consultations of the Hospital Universitario Fundación Jiménez Díaz, with a diagnosis of stable HF and with a LVEF ≤ 40%.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Fundación Jiménez Dia University Hospital, IIS-FJD
Madrid, 28040
Rocío Carda, Md, PhD
About this study
Official title: The Role of Bioimpedance Analysis in Diagnosis and Evaluation of Patients With Chronic Heart Failure and Systolic Ventricular Dysfunction. Correlation of This Tool With Other Heart Failure Markers
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.
Read the detailed 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.
- Conditions
- Heart Failure
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients Volemia status
determine the volemia status of the patients with the BIA parameters
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start7 Sep 2022
- Primary completion7 Dec 2022
- Study completion7 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rocio Carda Barrio, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Investigators
- Hans Gaebelt, MD, PhD, Study director, Fundación Jiménez Dia University Hospital, IIS-FJD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05631275
- Sponsor's protocol ID
- PIC003-20_FJD
- Status last verified
- Mar 2023
- First submitted
- 21 Nov 2022
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Bioimpedance Analysis in Diagnosis and Evaluation of Patients With Chronic Heart Failure and Systolic Ventricular Dysfunction. Correlation of This Tool With Other Heart Failure Markers
- ClinicalTrials.gov ID
- NCT05631275
- Acronym / sponsor ID
- PIC003-20_FJD
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez DíazUniversity, hospital or other
- Study start
- 7 Sep 2022 (actual)
- Primary completion
- 7 Dec 2022 (actual)
- Study completion
- 7 Sep 2023 (estimated)
- First posted
- 30 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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%
Key inclusion criteria (1 listed)
- Outpatients attended at cardiology consultations of the Hospital Universitario Fundación Jiménez Díaz, with a diagnosis of stable HF and with a LVEF ≤ 40%.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patients Volemia status
Time frame: 15 minutes
determine the volemia status of the patients with the BIA parameters
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans Gaebelt, MD, PhD study director
Fundación Jiménez Dia University Hospital, IIS-FJD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rocío Carda, MD, PhD (+34915504800, rcarda@fjd.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients Volemia status (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2023.