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

NCT04498780 | Completed DMC FDA Drug

• 1 other identifier: DL-L-20005_V1.4
• Study Type: observational
• Target: 117
• Locations: 1 country
• Sites: 2

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.

Conditions

Heart Failure With Reduced Ejection Fraction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Systolic and diastolic LV function, symptom status and biomarkers

  3, 6 and 12 months

• Left ventricular contractility, afterload and ventricular-arterial coupling

  3 and 12 months

Other Outcomes (1)

• Load-independent parameters of systolic and diastolic LV function, myocardial work indices

  3, 6 and 12 months

Interventions

Sacubitril-Valsartan DRUG

Observational study during the clinically indicated treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with symptomatic heart failure (NYHA functional class II to IV) and reduced ejection fraction (LVEF≤40%) with clinical indication for therapy with Sacubitril-Valsartan

You may qualify if:

• Symptomatic heart failure (NYHA functional class II to IV)
• Reduced LV ejection fraction (≤ 40%)
• Clinical indication for therapy with Sacubitril-Valsartan

You may not qualify if:

• existing therapy with Sacubitril-Valsartan
• participation in another randomized heart failure trial
• severe aortic or mitral valve lesion

Sponsors & Collaborators

• University of Leipzig: lead

Study Sites (2)

University of Leipzig

Leipzig, Saxony, 04103, Germany

Location

Kardiopraxis Schirmer

Kaiserslautern, Germany

Location

MeSH Terms

Interventions

sacubitril and valsartan sodium hydrate drug combination

Study Officials

• Daniel Lavall, MD

  University of Leipzig

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med. Daniel Lavall

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 4, 2020
• Study Start: July 21, 2020
• Primary Completion: December 31, 2025
• Study Completion: April 8, 2026
• Last Updated: April 8, 2026

Record last verified: 2023-05

Locations

DE (2)