A dynamic, multiple-biomarker approach aiming for individualized treatment of heart failure with preserved ejection fractio

Recruiting

Conditions: Heart failure
HFpEF
10019280

Registration Number: NL-OMON51533

Lead Sponsor: niversitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 200

Inclusion Criteria

- Age of 18 years or older
AND
- Capable of understanding and signing informed consent
AND
- A diagnosis of HFpEF according to the HFA-PEFF diagnostic algorithm of the
ESC,
OR
- 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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is a combined endpoint of urgent visit resulting in<br /><br>intravenous therapy for HF, hospital readmission for acute or worsened HF, and<br /><br>cardiovascular death.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoints are:<br /><br>- the separate components of the combined primary endpoint; urgent visit<br /><br>resulting in intravenous therapy for heart failure, hospital readmission for<br /><br>acute or worsened HF, and cardiovascular death.<br /><br>- The combined endpoint urgent visit resulting in intravenous therapy for HF,<br /><br>hospital readmission for acute or worsened HF, and all-cause death.<br /><br>- All-cause death<br /><br>- Myocardial infarction (fatal and non-fatal), stroke (fatal and non-fatal),<br /><br>percutaneous coronary intervention (PCI) and coronary artery bypass grafting<br /><br>(CABG)<br /><br>- Cardiovascular disease (includes all of the above, except all-cause death)</p><br>