Status:
UNKNOWN
Hemodynamic Effects of ARNI on Noninvasive Pressure-volume Analysis in Patients With Chronic Heart Failure
Lead Sponsor:
University of Leipzig
Conditions:
Heart Failure With Reduced Ejection Fraction
Eligibility:
All Genders
18+ years
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-pr...
Eligibility Criteria
Inclusion
- Symptomatic heart failure (NYHA functional class II to IV)
- Reduced LV ejection fraction (≤ 40%)
- Clinical indication for therapy with Sacubitril-Valsartan
Exclusion
- 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
Key Trial Info
Start Date :
July 21 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT04498780
Start Date
July 21 2020
End Date
December 31 2025
Last Update
May 12 2023
Active Locations (2)
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1
University of Leipzig
Leipzig, Saxony, Germany, 04103
2
Kardiopraxis Schirmer
Kaiserslautern, Germany