Heart Failure With Reduced Ejection Fraction
Conditions
Brief summary
Sacubitril-Valsartan reduced heart failure hospitalizations and cardiovascular mortality compared to enelapril in chronic heart failure. Furthermore, quality of life is improved. The decrease of NT-proBNP levels during Sacubitril-Valsartan treatment is associated with reverse left ventricular remodeling and improved left ventricular systolic function. However, the underlying mechanisms that contribute to these symptomatic and prognostic benefits are largely unknown. The aim of this study is to evaluate left ventricular hemodynamics in patients treated with Sacubitril-Valsartan using non-invasive pressure-volume analysis.
Interventions
DRUGSacubitril-Valsartan
Observational study during the clinically indicated treatment
Sponsors
University of Leipzig
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Symptomatic heart failure (NYHA functional class II to IV) * Reduced LV ejection fraction (≤ 40%) * Clinical indication for therapy with Sacubitril-Valsartan
Exclusion criteria
* catecholamine therapy at inclusion * existing therapy with Sacubitril-Valsartan * planned cardiac resynchronization therapy (CRT) within 6 months; inclusion at least 3 months after CRT * planned mitral or aortic valve procedure within 6 months; inclusion at least 3 months after valve procedure * participation in another randomized heart failure trial * severe aortic or mitral valve lesion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Left ventricular contractility, afterload and ventricular-arterial coupling | 6 months | Change of end-systolic elastance (Ees), arterial elastance (Ea) and ventricular-arterial coupling (Ea/Ees) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systolic and diastolic LV function, symptom status and biomarkers | 3, 6 and 12 months | * Echocardiography: Left ventricular (LV) remodeling und function (LVEDV, LVESV, LVEF, GLS), diastolic LV function (LAESV, E/e', LVEDP) * Symptoms: NYHA functional class, 6 minute walk test * Biomarker: NT-proBNP |
| Left ventricular contractility, afterload and ventricular-arterial coupling | 3 and 12 months | Change of end-systolic elastance (Ees), arterial elastance (Ea) and ventricular-arterial coupling (Ea/Ees) |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORDaniel Lavall, MD
University of Leipzig
Outcome results
None listed