Prospective Observational Study of the Sacubitril-Valsartan Treatment Effectiveness.

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: April 4, 2021

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Difference in the treatment response to Sacubitril-Valsartan depending on the ventricular dysfunction etiology.
    • Time Frame: 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 Measures

  • Determine the microRNA genetic profile in heart failure.
    • Time Frame: 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.

Participating in This Clinical Trial

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%.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Gonzalo Baron Esquivias, Principal Investigator, Hospital Universitario Virgen Macarena
  • Overall Contact(s)
    • Gonzalo Baron Esquivias, 955 00 80 00, gonzalo.baron.sspa@juntadeandalucia.es

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