Actively Recruiting
Value of Intense Phenotyping in Heart Failure With Preserved Ejection Fraction
Led by University Medical Center Groningen · Updated on 2024-05-16
200
Participants Needed
1
Research Sites
457 weeks
Total Duration
On this page
AI-Summary
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
CONDITIONS
Official Title
Value of Intense Phenotyping in Heart Failure With Preserved Ejection Fraction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age >18 years
- Written informed consent
- Heart failure with moderate to severe symptoms classified as NYHA class II or III
- Recent hospitalization or emergency room visit for heart failure or symptom relief with diuretics
- Sinus rhythm or atrial fibrillation
- Left ventricular ejection fraction >0.40
- Left atrial enlargement (volume 629 mL/m2 or parasternal diameter 645), or left ventricular hypertrophy (septal or posterior wall thickness 611 mm), or left ventricular diastolic dysfunction (E/e' 613 or mean e' <9 cm/s)
- Elevated biomarkers: BNP >31 ng/L or NT-pro-BNP >125 ng/L if in sinus rhythm
- Elevated biomarkers: BNP >75 ng/L or NT-pro-BNP >300 ng/L if in atrial fibrillation
You will not qualify if you...
- Unwilling or unable to provide informed consent
- Presence of a pacemaker or implantable cardioverter defibrillator (ICD)
- Indication for ICD therapy according to ESC guidelines
- Life expectancy less than one year
- Significant coronary artery disease or myocardial infarction within the last 3 months
- Complex congenital heart disease
- Pregnancy
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Medical Center Groningen
Groningen, Netherlands
Actively Recruiting
Research Team
M
Michiel Rienstra, MD PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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