Prospective Observational Study of the Sacubitril-Valsartan Treatment Effectiveness.

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 Overview

• Status: Unknown
• Conditions: Heart Failure
• Intervention / Treatment: Drug: Sacubitril-Valsartan

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Spain
  • Sevilla, Spain, 41009
    • Recruiting
    • Hospital Universitario Virgen Rocio
    • Contact: Gonzalo Baron Esquivias; Phone Number: 955 00 80 00; Email: gonzalo.baron.sspa@juntadeandalucia.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients older than 18 years old, diagnosed with heart failure and EF ≤ 40%, that after being treated with optimal medical treatment for at least 3 months, remain in functional class II, III or IV. Being this the actual indication for Sacubitril-Valsartan.

100 consecutive patients will be included, 50 of whom with ischemic etiology of heart failure and 50 with non-ischemic, excluding patients with enolic etiology, any contraindication for the treatment intake and that have already been treated with Sacubitril-Valsartan.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the connection between the biomarkers levels in heart failure and the cardiac remodeling parameters.	Demonstrate if there´s a possible relation between the biomarkers levels in heart failure and an improvement in the cardiac remodeling.	Up to 6 months after the beginning of the Sacubitril-Valsartan treatment
Study the levels of auricular natriuretic peptide (ANP), auricular natriuretic peptide type B (BNP), urocortin and type I-C terminal pro-collagen.	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.	Up to 6 months after the beginning of the Sacubitril-Valsartan treatment

Collaborators and Investigators

• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Investigators: Principal Investigator: Gonzalo Baron Esquivias, Hospital Universitario Virgen Macarena

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2019
• Primary Completion (Anticipated): April 4, 2021
• Study Completion (Anticipated): July 15, 2021

Study Registration Dates

• First Submitted: October 17, 2019
• First Submitted That Met QC Criteria: October 17, 2019
• First Posted (Actual): October 21, 2019

Study Record Updates

• Last Update Posted (Actual): February 7, 2020
• Last Update Submitted That Met QC Criteria: February 6, 2020
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Heart failure; Sacubitril-Valsartan; Severe systolic disfunction
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Valsartan; Sacubitril and valsartan sodium hydrate drug combination
• Other Study ID Numbers: FIS-SAC-2018-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No