NCT06785506 Multiple-biomarker Approach for Individualized Treatment of Heart Failure with Preserved Ejection Fraction
| NCT ID | NCT06785506 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Erasmus Medical Center |
| Condition | Heart Failure with Preserved Ejection Fraction |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2022-11-25 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2022-11-25 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06785506 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure with Preserved Ejection Fraction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06785506 currently recruiting?
Yes, NCT06785506 is actively recruiting participants. Contact the research team at i.kardys@erasmusmc.nl for enrollment information.
Where is the NCT06785506 trial being conducted?
This trial is being conducted at Alkmaar, Netherlands, Amsterdam, Netherlands, Amsterdam, Netherlands, Rotterdam, Netherlands and 2 additional locations.
Who is sponsoring the NCT06785506 clinical trial?
NCT06785506 is sponsored by Erasmus Medical Center. The trial plans to enroll 200 participants.
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