Inflammatory biomarkers and bioimpedance in decompensated heart failure with preserved or mildly reduced ejection fraction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study measures inflammatory biomarkers and bioimpedance parameters from blood samples collected during hospitalization for decompensated heart failure. The goal is to see if these biomarkers correlate with prognosis and whether specific gene markers are linked to higher risk of future cardiovascular events. Participants are adults with LVEF ≥40% and structural heart disease, admitted under Framingham criteria with elevated NT-proBNP. Data collection focuses on inflammatory profiles and genetic associations to inform personalized risk stratification. No intervention beyond sample collection is performed.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital Fundacion Jimenez Diaz
  Madrid, Madrid, Spain Recruiting

Study contacts

• Study coordinator: Ana Venegas
• Email: ana.venegas@quironsalud.es
• Phone: +34685286550

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.