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Value of Intense Phenotyping in Heart Failure With Preserved Ejection Fraction

Recruitingn/aAges 18 Years - anyAllUniversity Medical Center Groningen
NCT05479669 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: Clinical criteria: 1. Age \>18 years 2. Written informed consent 3. HF with moderate to severe symptoms NYHA II or III 4. Hospitalization or emergency room visit for HF or symptom relief with diuretics 5. Sinus rhythm or AF Echocardiographic criteria: 1. LVEF \>0.40 2. 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: 1. BNP \>31ng/L or NT-pro-BNP\>125ng/L if sinus rhythm 2. BNP \>75ng/L or NT-pro-BNP\>300ng/L if atrial fibrillation Exclusion Criteria: 1. Patients unwilling or unable to sign informed consent 2. Patients with a pacemaker or ICD 3. Indication for ICD therapy according to the ESC guidelines 4. Life expectancy of less than one year 5. Significant coronary artery disease or myocardial infarction \< 3 months 6. Complex congenital heart disease 7. Pregnancy
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What it tests

  • Echocardiography
  • 24 hour Holter monitoring
  • Cardiac Magnetic Resonance Imaging
  • 99mTc-HDP scan
  • ECG
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Where

1 site
University Medical Center Groningen
Groningen, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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