Inflammation BiomarkersBIOFEVIPNCT07320014
Descriptive Study of Circulating Gene or Protein Inflammatory Biomarkers and Bioimpedance Parameters in a Population of Patients Hospitalized for Decompensated Heart Failure With Preserved or Mildly Reduced Cardiac Function
An observational study of Inflammation Biomarkers and Heart Failure, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
Trial summary
The goal of this observational study is to determine whether changes in the inflammatory profile of heart failure patients can help identify those who may have a worse prognosis or who might benefit more from specific treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammation Biomarkers, Heart Failure
- What is being tested?
- Inflammatory biomarker sample collection
- How many people
- 112 participants
- Where
- 1 siteSpain
- Study dates
- 12 Jan 2026to Jan 2028
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: All patients hospitalized for HF at the FundaciJiménez Díaz University Hospital (Madrid), with preserved or slightly reduced LV ejection fraction (LVEF ≥40%), with evidence of structural heart disease (left atrial dilation or left ventricular hypertrophy) and elevated natriuretic peptides.
Who may be able to join
- Age ≥18 years at recruitment.
- Signed informed consent.
- Hospitalization due to decompensated heart failure, based on Framingham criteria and elevated natriuretic peptides (N-terminal of the prohormone brain natriuretic peptide (NT-proBNP) ≥450 pg/ml, or ≥900 pg/ml for patients with atrial fibrillation or flutter).
- Left ventricular ejection fraction(LVEF) ≥40% and evidence of structural heart disease based on the presence of at least one of the following imaging criteria:
- Left atrial dilation: LA diameter ≥3.8 cm, or area ≥20 cm², or LA volume ≥55 ml, or indexed LA volume ≥29 ml/m².
- Left ventricular hypertrophy, defined as septal or posterior wall thickness ≥1.1 cm.
- Evidence of increased filling pressures, measured by septal or lateral E/e' ratio >15 or >12, respectively.
Who cannot join
- Hemodynamic instability at the time of inclusion.
- Heart failure secondary to acute myocardial infarction (AMI).
- Pregnant or breastfeeding women.
- Comorbidities that could influence the clinical course:
- COPD requiring long-term home oxygen therapy, oral corticosteroids, hospitalization due to exacerbation, or primary pulmonary arterial hypertension.
- Chronic treatment with immunosuppressants, corticosteroids, or IL-1 antagonists within the 6 months prior to inclusion.
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- Confirmed active infection or patients currently receiving antibiotic treatment.
- Acute or chronic liver disease.
- Chronic kidney disease with eGFR <15 ml/min/1.73 m² or need for dialysis during hospitalization.
- Hematological disorders, such as blood dyscrasias or hemoglobin <9 g/dl on admission.
- Active oncological disease, except treated basal cell carcinoma or low-risk prostate cancer.
- Patients with limb amputation or carriers of pacemakers or defibrillators (due to possible errors in BIA measurements).
- Any disease associated with a life expectancy of less than one year, or patients expected to have difficulty adhering to the study protocol
- Patients actively participating in other clinical trials involving investigational drugs at the time of inclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Fundacion Jimenez Diaz
Madrid, Madrid, 28040
Ana Venegas, 34915 50 48 00, ana.venegas@quironsalud.es
About this study
Official title: Inflammatory Profile in Patients Hospitalized for Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Its Correlation With Bioimpedance Parameters and Other Biomarkers With Prognostic Value
The goal of this observational study is to determine whether changes in the inflammatory profile of heart failure patients can help identify those who may have a worse prognosis or who might benefit more from specific treatments. In addition, we aim to explore whether certain genes or gene mutations are related to a higher risk of future cardiovascular problems.
Heart failure continues to be a major cause of hospital admissions and death in our society. Because of this, it is very important for healthcare professionals to identify which patients are at higher risk of complications, so that we can provide the best possible treatment and follow-up. One method we use to help predict how the disease may evolve is the study of biomarkers, which are measurable biological substances that can help detect, monitor, or treat illnesses in a more personalized way.
Read more
In this study, the investigators will measure mainly inflammatory biomarkers that will be analyzed from a blood sample taken during hospital stay after being diagnosed with heart failure with preserved or mildly reduced ejection fraction. Any important health events that happen during the next six months after patients are discharged from hospital will also be recorded.
In addition, it is known that more than 2,000 diseases are known to be caused by changes in specific genes. In the case of cardiomyopathies-heart muscle diseases that can lead to heart failure-genetic causes vary depending on the type, and studies suggest that between 10% and 50% of cases may have a genetic origin. Identifying genetic markers linked to heart failure with preserved or mildly reduced ejection fraction may help improve prevention, treatment, and risk assessment, as some genetic changes may be associated with repeated cardiovascular events. By studying not only circulating biomarkers but also genetic factors, the investigators hope to better understand whether certain gene alterations may increase a person's tendency to experience additional heart-related events.
This is an observational study, which means that medical care and treatment will be exactly the same whether patients choose to participate or not. Participation involves allowing researchers to collect relevant information from medical records and agreeing to the collection of two or three small additional blood samples for research purposes. These samples will be used to measure the biomarkers and to analyze genes in the white blood cell fraction obtained from the same tubes.
- Conditions
- Inflammation Biomarkers, Heart Failure
- Being tested
- Inflammatory biomarker sample collection
- Keywords
- inflammatory profile, heart failure with preserved ejection fraction, heart failure with mildly reduced ejection fraction, bioimpedance
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inflammatory biomarker sample collectionOther
This is a prospective observational study in which a blood sample and a urine sample will be taken from all subjects in the first hours after admission. In addition, all subjects will be asked for specific consent for the isolation of plasma protein and nucleic acid (DNA/RNA). In addition, an echocardiogram and bioimpedance analysis will be performed in all patients included in the study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of circulating inflammatory gene or protein biomarkers and other biomarkers with prognostic value in a population of patients hospitalized for acute HF.
Biomarkers with prognostic value in heart failure such as troponins, natriuretic peptides or CA-125, biomarkers of mineral metabolism and inflammatory or profibrotic biomarkers including C- reactive protein, tumoral necrosis factor-α, interleukins, galectin-3, MCP-1, pentraxin-3 or myeloperoxidase, will be measured at admission in a population of patients hospitalized for decompensated heart failure with preserved or mildly reduced left ventricular ejection fraction.
Measured: At enrollment
Description of parameters obtained by bioimpedance analysis (BIA) in a population of patients hospitalized for decompensated HF with preserved or mildly reduced ejection fraction.
Description of parameters obtained by bioimpedance analysis, including the assessment of body composition, hydration status and nutritional status in a population of patients hospitalized for decompensated HF with preserved or mildly reduced ejection fraction.
Measured: At enrollment
Secondary outcomes (5)
Incidence of major cardiovascular events in a population of patients hospitalized for decompensated HF with preserved or mildly reduced LV ejection fraction and its correlation with the inflammatory status.
Description of the incidence of all-cause mortality, cardiovascular mortality, heart failure hospitalization or Emergency-Department visit requiring intravenous diuretics in the first 6 months after discharge in a population of patients hospitalized for decompensated HF with preserved or mildly reduced LV ejection fraction and its correlation with the inflammatory status.
Measured: From inclusion to 6 months after discharge
Prognostic correlation of inflammatory biomarkers with the parameters obtained by bioimpedance analysis.
To evaluate the prognostic correlation of inflammatory biomarkers measured in patients hospitalized for decompensated HF with preserved or mildly reduced LV ejection fraction with the parameters obtained by bioimpedance analysis performed at the time of inclusion, including both hydration and nutritional status.
Measured: At enrollment
Correlation of inflammatory biomarkers with other circulating biomarkers with prognostic value in HF.
To study the correlation of the inflammatory profile alterations with other biomarkers with prognostic value in HF such as natriuretic peptides and fibrosis or mineral metabolism biomarkers.
Measured: At enrollment
Correlation of inflammatory biomarkers with echocardiographic data with prognostic value
To examine the correlation of inflammatory biomarkers with echocardiographic study at enrollment, including left ventricular ejection fraction (LVEF), valvular heart disease, left ventricular end-diastolic diameter, myocardial wall thickness, left ventricular mass, parameters of left atrial dilation, right ventricular size and function, and parameters related to diastolic function.
Measured: At enrollment
Identification of different patient subgroups according to prognosis based on the inflammatory study.
To describe patient subgroups with different prognosis according to the etiology of heart failure or its associated comorbiditiesbased on the alterations identified in the inflammatory study.
Measured: From inclusion to 6 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start12 Jan 2026
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammation BiomarkersStudies 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
- 112 participants (estimated)
- Target duration
- 6 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, Ana María Venegas Rodriguez, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07320014
- Sponsor's protocol ID
- PIC011-25_FJD
- Acronym
- BIOFEVIP
- Status last verified
- Nov 2026
- First submitted
- 8 Dec 2025
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Profile in Patients Hospitalized for Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Its Correlation With Bioimpedance Parameters and Other Biomarkers With Prognostic Value
- ClinicalTrials.gov ID
- NCT07320014
- Acronym / sponsor ID
- BIOFEVIP / PIC011-25_FJD
- Conditions
- Inflammation Biomarkers, Heart Failure
- Keywords
- inflammatory profile, heart failure with preserved ejection fraction, heart failure with mildly reduced ejection fraction, bioimpedance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez DíazUniversity, hospital or other
- Study start
- 12 Jan 2026 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 6 Jan 2026 (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.
The goal of this observational study is to determine whether changes in the inflammatory profile of heart failure patients can help identify those who may have a worse prognosis or who might benefit more from specific treatments. In addition, we aim to explore whether certain genes or gene mutations are related to a higher risk of future cardiovascular problems.
Heart failure continues to be a major cause of hospital admissions and death in our society. Because of this, it is very important for healthcare professionals to identify which patients are at higher risk of complications, so that we can provide the best possible treatment and follow-up. One method we use to help predict how the disease may evolve is the study of biomarkers, which are measurable biological substances that can help detect, monitor, or treat illnesses in a more personalized way.
In this study, the investigators will measure mainly inflammatory biomarkers that will be analyzed from a blood sample taken during hospital stay after being diagnosed with heart failure with preserved or mildly reduced ejection fraction. Any important health events that happen during the next six months after patients are discharged from hospital will also be recorded.
In addition, it is known that more than 2,000 diseases are known to be caused by changes in specific genes. In the case of cardiomyopathies-heart muscle diseases that can lead to heart failure-genetic causes vary depending on the type, and studies suggest that between 10% and 50% of cases may have a genetic origin. Identifying genetic markers linked to heart failure with preserved or mildly reduced ejection fraction may help improve prevention, treatment, and risk assessment, as some genetic changes may be associated with repeated cardiovascular events. By studying not only circulating biomarkers but also genetic factors, the investigators hope to better understand whether certain gene alterations may increase a person's tendency to experience additional heart-related events.
This is an observational study, which means that medical care and treatment will be exactly the same whether patients choose to participate or not. Participation involves allowing researchers to collect relevant information from medical records and agreeing to the collection of two or three small additional blood samples for research purposes. These samples will be used to measure the biomarkers and to analyze genes in the white blood cell fraction obtained from the same tubes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients hospitalized for HF at the FundaciJiménez Díaz University Hospital (Madrid), with preserved or slightly reduced LV ejection fraction (LVEF ≥40%), with evidence of structural heart disease (left atrial dilation or left ventricular hypertrophy) and elevated natriuretic peptides.
Key inclusion criteria (7 listed)
- Age ≥18 years at recruitment.
- Signed informed consent.
- Hospitalization due to decompensated heart failure, based on Framingham criteria and elevated natriuretic peptides (N-terminal of the prohormone brain natriuretic peptide (NT-proBNP) ≥450 pg/ml, or ≥900 pg/ml for patients with atrial fibrillation or flutter).
- Left ventricular ejection fraction(LVEF) ≥40% and evidence of structural heart disease based on the presence of at least one of the following imaging criteria:
Key exclusion criteria (14 listed)
- Hemodynamic instability at the time of inclusion.
- Heart failure secondary to acute myocardial infarction (AMI).
- Pregnant or breastfeeding women.
- Comorbidities that could influence the clinical course:
- Patients actively participating in other clinical trials involving investigational drugs at the time of inclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inflammatory biomarker sample collectionThis is a prospective observational study in which a blood sample and a urine sample will be taken from all subjects in the first hours after admission. In addition, all subjects will be asked for specific consent for the isolation of plasma protein and nucleic acid (DNA/RNA). In addition, an echocardiogram and bioimpedance analysis will be performed in all patients included in the study. | Other | – |
Primary outcome
Description of circulating inflammatory gene or protein biomarkers and other biomarkers with prognostic value in a population of patients hospitalized for acute HF.
Time frame: At enrollment
Biomarkers with prognostic value in heart failure such as troponins, natriuretic peptides or CA-125, biomarkers of mineral metabolism and inflammatory or profibrotic biomarkers including C- reactive protein, tumoral necrosis factor-α, interleukins, galectin-3, MCP-1, pentraxin-3 or myeloperoxidase, will be measured at admission in a population of patients hospitalized for decompensated heart failure with preserved or mildly reduced left ventricular ejection fraction.
Description of parameters obtained by bioimpedance analysis (BIA) in a population of patients hospitalized for decompensated HF with preserved or mildly reduced ejection fraction.
Time frame: At enrollment
Description of parameters obtained by bioimpedance analysis, including the assessment of body composition, hydration status and nutritional status in a population of patients hospitalized for decompensated HF with preserved or mildly reduced ejection fraction.
5 secondary outcomes
Incidence of major cardiovascular events in a population of patients hospitalized for decompensated HF with preserved or mildly reduced LV ejection fraction and its correlation with the inflammatory status.
Time frame: From inclusion to 6 months after discharge
Prognostic correlation of inflammatory biomarkers with the parameters obtained by bioimpedance analysis.
Time frame: At enrollment
Correlation of inflammatory biomarkers with other circulating biomarkers with prognostic value in HF.
Time frame: At enrollment
Correlation of inflammatory biomarkers with echocardiographic data with prognostic value
Time frame: At enrollment
Identification of different patient subgroups according to prognosis based on the inflammatory study.
Time frame: From inclusion to 6 months after discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
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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.
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 Inflammation Biomarkers and 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 7 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 5 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ana Venegas (+34685286550, ana.venegas@quironsalud.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of circulating inflammatory gene or protein biomarkers and other biomarkers with prognostic value in a population of patients hospitalized for acute HF. (time frame: At enrollment). The study lists 2 primary outcomes in all. 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 5 Nov 2026.