Assessing risk factors in heart failure with preserved ejection fraction
Value of Intense Phenotyping in Heart Failure With Preserved Ejection Fraction
This study is trying to find out what factors can predict hospital visits and death in people with heart failure who still have a good heart function.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Center Groningen Academic / other |
| Locations | 1 site (Groningen) |
| Trial ID | NCT05479669 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with symptomatic heart failure (NYHA class II-III) and a recent hospitalization or emergency visit.
Not a fit: Patients with a life expectancy of less than one year or significant coronary artery disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify high-risk patients and improve management strategies for heart failure with preserved ejection fraction.
How similar studies have performed: While heart failure with preserved ejection fraction is a challenging area, similar studies have shown promise in identifying risk factors, though this specific approach may be novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Groningen
- 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
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.