I50
Conditions
Interventions
Group 1: Z02 will recruit, deeply phenotype, and longitudinally follow-up a prospective cohort of 400 patients with HFpEF and 138 with preHFpEF. A key feature of the study is the extensive clinical ph
Sponsors
Charité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Age = 18 years 2) Written informed consent 3) Presence of signs and symptoms of heart failure corresponding to a NYHA class = 2. 4) Echocardiographically preserved ejection fraction (LVEF = 50%). 5) NTproBNP >125 pg/mL (SR) or >365 pg/mL (VHFL) or BNP >35 pg/mL (SR) or >105 pg/mL (VHL). 6) Existence of structural and/or functional cardiac changes compatible with LV diastolic dysfunction or elevated left ventricular filling pressures, respectively. Applicability of at least one of the following echocardiographic or invasive criteria: - LV mass index = 95 g/m2 (women), >_115 g/m2 (men) and relative wall thickness >0.42 - LA volume index > 34mL/m2 (SR) or > 40 ml/m2 (VHFL). - E/e' ratio at rest = 13 - PA systolic pressure >35 mmHg (invasive under stress). - TR velocity at rest > 2.8 m/s (invasive under stress)
Exclusion criteria
Exclusion criteria: 1) Life expectancy 2) or severe anemia (Hb<10g/dl in men and Hb <9.5g/dl in women).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite of cardiovascular mortality and total (first and recurrent) HF hospitalizations. | — |
Secondary
| Measure | Time frame |
|---|---|
| - All-cause mortality, - overall cardiovascular hospitalization rate, - and changes in left ventricular ejection fraction (LVEF), New York Heart Association (NYHA) class, and Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score at 24-month intervals. | — |
Countries
Germany
Contacts
Public ContactFrank Edelmann
Deutsches Herzzentrum der Charité Klinik für Kardiologie, Angiologie und Intensivmedizin Campus Virchow-Klinikum
Outcome results
None listed