Prospective Observational Study of the Sacubitril-Valsartan Treatment Effectiveness.

Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla (Other)

Overall Status

Unknown status

CT.gov ID

NCT04133428

Collaborator

(none)

100

Enrollment

Location

27.4

Anticipated Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Drug: Sacubitril-Valsartan

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Prospective Observational Study of the Sacubitril-Valsartan Treatment Effectiveness.

Actual Study Start Date :

Apr 4, 2019

Anticipated Primary Completion Date :

Apr 4, 2021

Anticipated Study Completion Date :

Jul 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Sacubitril-Valsartan cohort 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 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.

Arm

Intervention/Treatment

Sacubitril-Valsartan cohort

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

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.

Outcome Measures

Primary Outcome Measures

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

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.

Other Outcome Measures

Evaluate the connection between the biomarkers levels in heart failure and the cardiac remodeling parameters. [Up to 6 months after the beginning of the Sacubitril-Valsartan treatment]
Demonstrate if there´s a possible relation between the biomarkers levels in heart failure and an improvement in the cardiac remodeling.
Study the levels of auricular natriuretic peptide (ANP), auricular natriuretic peptide type B (BNP), urocortin and type I-C terminal pro-collagen. [Up to 6 months after the beginning of the Sacubitril-Valsartan treatment]
Study the levels of ANP, BNP and urocortin as cardioprotective molecules as well as type I-C terminal pro-collagen as measurement of peripheral blood fibrosis.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.