Prospective Observational Study of the Sacubitril-Valsartan Treatment Effectiveness.

• Conditions: Heart Failure
• Interventions: Drug: Sacubitril-Valsartan

• Registration Number: NCT04133428
• Lead Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Brief Summary

The aim of this prospective study is to demonstrate if there is any difference in the treatment response to Sacubitril-Valsartan depending on the ventricular disfunction ethiology in patients with severe systolic disfunction heart failure.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-04
• Status Verified: 2019-10
• Study First Submitted: 2019-10-17
• Study First Submitted QC: 2019-10-17
• Study First Posted: 2019-10-21
• Last Update Submitted: 2020-02-06
• Last Update Posted: 2020-02-07
• Primary Completion: 2021-04-04
• Study Completion: 2021-07-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients older than 18 years old.
• Ejection fraction (EF) ≤ 40%.
• Treated with optimal medical treatment for at least 3 months and remained in functional class II, III or IV.
• Patients with ischemic or non ischemic etiology.

Exclusion Criteria

• Patients with enolic etiology.
• Patients with any contraindication for taking Sacubitril-Valsartan.
• Patients with EF >40%.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sacubitril-Valsartan cohort	Sacubitril-Valsartan	Patients with severe systolic disfunction (left ventricle ejection fraction\<40%) heart failure that remain functional class II, III or IV after at least 3 months of optimal treatment and after being evaluated by the cardiologist by doing an echocardiography, blood test and clinical evaluation, start Sacubitril-Valsartan treatment.

Primary Outcome Measures

Name	Time	Method
Difference in the treatment response to Sacubitril-Valsartan depending on the ventricular dysfunction etiology.	Up to 6 months after the beginning of the Sacubitril-Valsartan treatment	Verify if there is any difference in the response to the treatment with Sacubitril-Valsartan depending on the ventricular dysfunction etiology, ischemic or non-ischemic (idiopathic/familiar,toxic, volume overload,etc) excluding enolic, of patients with severe systolic heart failure.

Secondary Outcome Measures

Name	Time	Method
Determine the microRNA genetic profile in heart failure.	Up to 6 months after the beginning of the Sacubitril-Valsartan treatment	Study of the microRNA genetic profile in heart failure as an indicator of the cardiac remodeling process and see its response and changes after undergoing Sacubitril-Valsartan treatment.

Trial Locations

Locations (1)

Hospital Universitario Virgen Rocío; 🇪🇸 Sevilla, Spain