Prospective Observational Study of the Sacubitril-Valsartan Treatment Effectiveness.

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Observational Study of the Sacubitril-Valsartan Treatment Effectiveness.

Conditions
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Heart Failure

Intervention / Treatment
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* Drug: Sacubitril-Valsartan


Participation Criteria
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Eligibility Criteria
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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%.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sacubitril-Valsartan cohort<br>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. | Drug: Sacubitril-Valsartan<br>* Evaluation of the Sacubitril-Valsartan treatment effectiveness. As there are three possible doses, during the first 30 days of treatment 3 evaluations will be carried out (every 10 days) for dose titration based on safety and tolerability as well as a blood test the 30rd day of treatment. Afterwards the patient will be evaluated after 3 and 6 months of treatment with a blood test and in the final visit (6 months) an echocardiography will be carried out and the final clinical evaluation will be made.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in the treatment response to Sacubitril-Valsartan depending on the ventricular dysfunction etiology. | 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. | Up to 6 months after the beginning of the Sacubitril-Valsartan treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the microRNA genetic profile in heart failure. | 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. | Up to 6 months after the beginning of the Sacubitril-Valsartan treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart failure, Severe systolic disfunction, Sacubitril-Valsartan