Value of Intense Phenotyping in Heart Failure With Preserved Ejection Fraction

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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

Locations
Other Locations
Netherlands
University Medical Center Groningen
RECRUITING
Groningen
Contact Information
Primary
Michiel Rienstra, MD PhD
m.rienstra@umcg.nl
0031503612878
Time Frame
Start Date: 2022-03-29
Estimated Completion Date: 2031-01-01
Participants
Target number of participants: 200
Sponsors
Leads: University Medical Center Groningen

This content was sourced from clinicaltrials.gov