Assessing risk factors in heart failure with preserved ejection fraction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the risk profile associated with all-cause mortality and hospitalizations in patients with heart failure and preserved ejection fraction (LVEF >0.40). It will involve a single-center, prospective design with a target population of 200 symptomatic heart failure patients who have experienced recent hospitalizations or emergency visits. Participants will undergo various assessments including echocardiography, cardiac magnetic resonance imaging, Holter monitoring, and blood sampling to identify clinical factors, imaging parameters, and biomarkers that predict risk. The study will follow participants for up to five years to determine the incidence of combined endpoints.

Why it matters

Who can join: the full rules

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

Where it's running

• University Medical Center Groningen
  Groningen, Netherlands Recruiting

Study contacts

• Principal investigator: Michiel Rienstra, MD PhD — University Medical Center Groningen
• Study coordinator: Michiel Rienstra, MD PhD
• Email: m.rienstra@umcg.nl
• Phone: 0031503612878

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.