Using blood biomarkers to personalize treatment for heart failure with preserved ejection fraction
A Dynamic, Multiple-biomarker Approach Aiming for Individualized Treatment of Heart Failure with Preserved Ejection Fraction (ADAPT-HFpEF)
This study is testing if tracking changes in blood markers can help doctors personalize treatment for people with heart failure and preserved ejection fraction.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 6 sites (Alkmaar, North Holland and 5 other locations) |
| Trial ID | NCT06785506 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between changes in blood biomarkers and clinical outcomes in patients with heart failure with preserved ejection fraction (HFpEF). Conducted across multiple centers, including the Erasmus Medical Centre and five other hospitals, the study will enroll 200 patients and follow them for a period of 2 to 3.5 years. Clinical data and blood samples will be collected at baseline and every six months to develop a predictive model for individual patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with HFpEF, as defined by specific diagnostic criteria.
Not a fit: Patients with a history of reduced left ventricular ejection fraction or other significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more tailored and effective treatment strategies for patients with HFpEF.
How similar studies have performed: While the approach of using biomarkers in heart failure is being explored, this specific multi-center observational study represents a novel effort to create a dynamic prediction model for HFpEF.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Alkmaar, North Holland and 5 other locations
- Noordwest Ziekenhuisgroep — Alkmaar, North Holland, Netherlands (Recruiting)
- Amsterdam UMC — Amsterdam, North Holland, Netherlands (Recruiting)
- OLVG Ziekenhuis — Amsterdam, North Holland, Netherlands (Recruiting)
- Franciscus Gasthuis & Vlietland Ziekenhuis — Rotterdam, South Holland, Netherlands (Recruiting)
- Erasmus MC — Rotterdam, South Holland, Netherlands (Recruiting)
- Ikazia Ziekenhuis — Rotterdam, South Holland, Netherlands (Recruiting)
Study contacts
- Study coordinator: Isabella Kardys, Prof.
- Email: i.kardys@erasmusmc.nl
- Phone: +31650032051
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.