Value of Intense Phenotyping in Heart Failure With Preserved Ejection Fraction
Recruiting · NCT05479669 · Observational (researchers observe without assigning treatment) · Lead sponsor: University Medical Center Groningen
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Heart failure (HF) with a left ventricular ejection fraction (LVEF) \>0.40 is a large medical problem, for which no drug or device has a recommendation in current HF guidelines. The prevalence of mortality and HF hospitalizations in HF with LVEF \>0.40 is high, but the identification of predictors for increased risk of mortality and HF hospitalizations in this patient category remains difficult. The hypothesis of this study is that the risk of all-cause mortality and HF hospitalizations can be measured by clinical factors, imaging parameters and circulating biomarkers, and that these factors can be used in a risk profile
Who can take part
Inclusion criteria
- Clinical criteria:
- Age \>18 years
- Written informed consent
- HF with moderate to severe symptoms NYHA II or III
- Hospitalization or emergency room visit for HF or symptom relief with diuretics
- Sinus rhythm or AF
- Echocardiographic criteria:
- LVEF \>0.40
- Left atrial size (volume ≥29 mL/m2 or LA parasternal diameter ≥45), or left ventricular hypertrophy (septal thickness or posterior wall thickness ≥11 mm) or LV diastolic dysfunction (E/e' ≥13 or mean e' septal and lateral wall \<9 cm/s).
- Biomarker criteria:
- BNP \>31ng/L or NT-pro-BNP\>125ng/L if sinus rhythm
- BNP \>75ng/L or NT-pro-BNP\>300ng/L if atrial fibrillation
Exclusion criteria
- Patients unwilling or unable to sign informed consent
- Patients with a pacemaker or ICD
- Indication for ICD therapy according to the ESC guidelines
- Life expectancy of less than one year
- Significant coronary artery disease or myocardial infarction \< 3 months
- Complex congenital heart disease
- Pregnancy
Where it is running
1 location listed.
- University Medical Center Groningen - Groningen, Netherlands