Status:
ACTIVE_NOT_RECRUITING
Longitudinal Multimarker Risk Models for Very Elderly Patients With Heart Failure and Preserved Ejection Fraction
Lead Sponsor:
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Collaborating Sponsors:
Instituto de Salud Carlos III
European Union
Conditions:
Heart Failure With Preserved Ejection Fraction
Eligibility:
All Genders
80+ years
Brief Summary
The goal of this observational study is to develop longitudinal multimarker risk models for decision support during the clinical follow-up of very elderly patients with heart failure and preserved eje...
Detailed Description
Background: Very elderly patients with heart failure and preserved ejection fraction (HFpEF) are under-represented in risk prediction models, and the role of prognostic biomarkers in this population i...
Eligibility Criteria
Inclusion
- age ≥80 years;
- diagnosis of HFpEF, requiring the 4 following conditions: b1) typical symptoms and/or signs of HF; b2) left ventricular ejection fraction (LVEF) ≥50%; b3) elevated levels of natriuretic peptides (NTproBNP ≥300 pg/mL or BNP ≥100 pg/mL in sinus rhythm; NT-proBNP ≥900 pg/mL or BNP ≥300 pg/mL in atrial fibrillation); and b4) at least one additional criterion: b4.1) relevant structural heart disease (left ventricular hypertrophy and/or left atrial enlargement), or 4.2) diastolic dysfunction;
- hospitalization with a primary diagnosis of acute HF; and
- giving informed consent.
Exclusion
- any clinical condition, such as HF secondary to congenital heart disease and severe valve disease, severe renal (requiring dialysis) and liver disease, active malignant diseases, autoimmune diseases, other diseases resulting in \<1-year life expectancy or any other condition that, according to investigators' criteria, could significantly interfere with the study objectives;
- any clinical or social condition that prevents clinical follow-up.
Key Trial Info
Start Date :
March 21 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 31 2026
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT05992558
Start Date
March 21 2023
End Date
January 31 2026
Last Update
March 17 2025
Active Locations (1)
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1
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Spain, 28034