RecruitingNCT06785506
Multiple-biomarker Approach for Individualized Treatment of Heart Failure with Preserved Ejection Fraction
A Dynamic, Multiple-biomarker Approach Aiming for Individualized Treatment of Heart Failure with Preserved Ejection Fraction (ADAPT-HFpEF)
Sponsor
Erasmus Medical Center
Enrollment
200 participants
Start Date
Nov 25, 2022
Study Type
OBSERVATIONAL
Conditions
Summary
The primary objective is to investigate the association between temporal evolutions of blood biomarkers and clinical adverse events, in order to produce a dynamic, individual, and accurate prediction model for patients with HFpEF. Moreover several secondary objectives will be investigated.
Eligibility
Min Age: 18 Years
Inclusion Criteria3
- Age of 18 years or older
- Capable of understanding and signing informed consent
- A diagnosis of HFpEF according to the HFA-PEFF diagnostic algorithm of the ESC or/and a high (90%) probability of HFpEF according to the H2FPEF score, i.e. a score of 6 or higher.
Exclusion Criteria10
- History of LVEF ≤40%
- Scheduled for surgery or intervention for both coronary and non-coronary indication within 6 months of inclusion
- Impaired renal function, defined as eGFR \< 20 mL/min/1.73 m2 (CKD-EPI) or requiring dialysis at the time of screening
- Acute or chronic liver disease, defined by serum levels of transaminases or alkaline phosphatase more than three times the upper limit of normal at screening
- COPD Gold stage IV
- Congenital heart disease
- Pregnancy
- Coexistent condition with life expectancy of \<1 year
- Unlikely to appear at all scheduled follow-up visits
- Linguistic barrier
Locations(6)
View Full Details on ClinicalTrials.gov
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NCT06785506
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