Can inflammation markers predict heart failure outcomes?
NCT ID NCT07320014
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This observational study will enroll 112 adults hospitalized for heart failure with preserved or mildly reduced ejection fraction. Researchers will collect blood and urine samples to measure inflammatory biomarkers and analyze genetic factors. The goal is to identify markers that predict complications and guide personalized treatment. Participation does not change standard medical care.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this study could help doctors better predict which heart failure patients are at higher risk of complications, leading to more personalized care.
- What could go wrong
- This is an observational study, not a treatment trial, so it won't directly change patient care. Results may not apply to all heart failure patients, and genetic findings may not be actionable.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 112 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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