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

• Sponsor: University of Leipzig (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04498780
• Collaborator: (none)
• Enrollment: 117
• Locations: 2
• Anticipated Duration (Months): 41.3
• Patients Per Site: 58.5
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure With Reduced Ejection Fraction	Drug: Sacubitril-Valsartan

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 117 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Hemodynamic Effects of Angiotensin Receptor Neprilysin Inhibition on Noninvasive Pressure-volume Analysis in Patients With Heart Failure With Reduced Ejection Fraction
• Actual Study Start Date: Jul 21, 2020
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2023

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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

2. 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)

Other Outcome Measures

1. Load-independent parameters of systolic and diastolic LV function, myocardial work indices [3, 6 and 12 months]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Leipzig	Leipzig	Saxony	Germany	04103
2	Kardiopraxis Schirmer	Kaiserslautern		Germany

Sponsors and Collaborators

• University of Leipzig

Investigators

• Principal Investigator: Daniel Lavall, MD, University of Leipzig

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daniel Lavall, Dr. med. Daniel Lavall, University of Leipzig
• ClinicalTrials.gov Identifier: NCT04498780
• Other Study ID Numbers: DL-L-20005_V1.4
• First Posted: Aug 4, 2020
• Last Update Posted: Dec 29, 2021
• Last Verified: Dec 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Heart Failure; Valsartan; Sacubitril and valsartan sodium hydrate drug combination

Study Results

No Results Posted as of Dec 29, 2021