NCT05479669Recruiting
Value of Intense Phenotyping in Heart Failure With Preserved Ejection Fraction
Source: ClinicalTrials.gov · Last updated 16 May 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 19 Jul 2022
- Start date
- 29 Mar 2022
- Primary completion date
- 1 Jan 2026
- Lead sponsor
- University Medical Center Groningen
- Diseases
- Heart failure
- NCT number
- NCT05479669
What you commit to
- Study type: Observational
- Planned participants: 200
- From 29 Mar 2022 to the primary completion date, 1 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Indication for ICD therapy according to the ESC guidelines
Other illness
- Significant coronary artery disease or myocardial infarction \< 3 months
- Complex congenital heart disease
Other
- Patients unwilling or unable to sign informed consent
- Patients with a pacemaker or ICD
- Life expectancy of less than one year
- Pregnancy
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Medical Center Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.