Hemodynamic Effects of ARNI on Noninvasive Pressure-volume Analysis in Patients With Chronic Heart Failure

Heart Failure With Reduced Ejection Fraction Clinical Trial

— ARNI-PVA  

Official title:

Hemodynamic Effects of Angiotensin Receptor Neprilysin Inhibition on Noninvasive Pressure-volume Analysis in Patients With Heart Failure With Reduced Ejection Fraction

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04498780
• Other study ID #: DL-L-20005_V1.4
• Status: Active, not recruiting
• Start date: July 21, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2023
• Source: University of Leipzig
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 117
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Reduced Ejection Fraction

Intervention

Drug:
• Sacubitril-Valsartan
Observational study during the clinically indicated treatment

Locations

Country	Name	City	State
Germany	Kardiopraxis Schirmer	Kaiserslautern
Germany	University of Leipzig	Leipzig	Saxony

Sponsors (1)

Lead Sponsor	Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Load-independent parameters of systolic and diastolic LV function, myocardial work indices	Peak power index (PPI); Preload-recruitable stroke work (PRSW); End-systolic meridional wall stress (EsMWS); Total peripheral resistance (TPR); LV end-systolic pressure (LVEDP); LV end-diastolic pressure-volume relationship (LVEDPVR); Pressure-strain loops	3, 6 and 12 months
Primary	Left ventricular contractility, afterload and ventricular-arterial coupling	Change of end-systolic elastance (Ees), arterial elastance (Ea) and ventricular-arterial coupling (Ea/Ees)	6 months
Secondary	Systolic and diastolic LV function, symptom status and biomarkers	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	3, 6 and 12 months
Secondary	Left ventricular contractility, afterload and ventricular-arterial coupling	Change of end-systolic elastance (Ees), arterial elastance (Ea) and ventricular-arterial coupling (Ea/Ees)	3 and 12 months