Prospective Observational Study of the Sacubitril-Valsartan Treatment Effectiveness.

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Status: Unknown

Conditions: Heart Failure

Treatments: Drug: Sacubitril-Valsartan

Study type: Observational

Funder types: Other

Identifiers

NCT04133428

FIS-SAC-2018-01

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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%.

Trial design

100 participants in 1 patient group

Sacubitril-Valsartan cohort

Description:

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.

Treatment:

Drug: Sacubitril-Valsartan