Role of Sacubitril/Valsartan in the Improvement of Heart Failure With Reduced Ejection Fraction

NCT04397302 | Completed

• 1 other identifier: 20190015213
• Study Type: observational
• Target: 652
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective study evaluates the mechanisms of benefit of sacubitril/valsartan in a population of outpatients with heart failure with reduced ejection fraction, to investigate the relationship between the effects on left ventricular ejection fraction and volumes and noninvasively hemodynamic echo-derived parameters, as cardiac output and left ventricular filling pressure.

Conditions

Heart Failure, Left Sided; Left Ventricular Dysfunction; Ventricular Remodeling

Keywords

Angiotensin-receptor neprilysin-inhibitor; Heart failure with reduced ejection fraction; Left ventricular filling pressure; Left ventricular reverse remodeling

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Cardiac Output after 12 months of treatment

  Cardiac Output (in L/min) is a variable measured by echocardiography as the product of LV stroke volume (in mL/beat) and heart rate (in bpm).

  March, 16 th 2019 - March,16th 2020

Secondary Outcomes (1)

• Change from baseline in Left Ventricular Filling Pressure after 12 months of treatment

  March, 16th 2019 - March,16th 2020

Other Outcomes (2)

• Change from baseline in Left Ventricular Stroke Volume after 12 months of treatment

  March, 16th 2019 - March,16th 2020

• Change from baseline in Left Ventricular End-systolic Volume after 12 months of treatment

  March, 16th 2019 - March,16th 2020

Interventions

Role of Sacubitril/Valsartan in Hemodynamic and Echocardiographic Improvement of Heart Failure With Reduced Ejection Fraction DIAGNOSTIC_TEST

Reverse Remodeling is Associated With Hemodynamic Improvement and Stabilization in Outpatients With Heart Failure With Reduced Ejection Fraction Treated With Sacubitril/Valsartan: an Echocardiographic Study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The participants were recruited from a population of ambulatory patients with heart failure and reduced LV ejection fraction, being treated by Units of Cardiology in 12 Italian University hospitals.

You may qualify if:

• Ambulatory patients on stable optimal medical therapy
• History of HF and LVEF ≤ 40%
• II-III NYHA class

You may not qualify if:

• History of congenital heart disease
• Severe valvular disease or valvular surgery
• Recent acute coronary syndromes or stroke
• Poor acoustic windows or missing data.
• Death or uncompleted follow-up evaluation
• Cardiac surgery interventions
• Cardiac resynchronization therapy
• Coronary or mitral interventions

Sponsors & Collaborators

• Italian Society of Cardiology: lead
• Università degli Studi di Brescia: collaborator
• Federico II University: collaborator
• Ospedali Riuniti di Foggia: collaborator
• University Of Perugia: collaborator
• Monaldi Hospital: collaborator
• University of Messina: collaborator
• University of Siena: collaborator
• University of Salerno: collaborator
• Fondazione IRCCS Policlinico San Matteo di Pavia: collaborator
• Azienda Ospedaliero-Universitaria di Parma: collaborator
• Azienda Unita Sanitaria Locale di Piacenza: collaborator

Study Sites (1)

Frank Lloyd Dini

Pisa, 56124, Italy

Location

Related Publications (22)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, Plasma

MeSH Terms

Conditions

Heart Failure; Ventricular Dysfunction, Left; Ventricular Remodeling

Interventions

Hemodynamics

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Frank L Dini, MD

  Italian Society of Cardiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 376 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 21, 2020
• Study Start: January 13, 2019
• Primary Completion: March 16, 2020
• Study Completion: March 16, 2020
• Last Updated: May 28, 2020

Record last verified: 2020-05

Locations

IT (1)