Changes in the T-wave Alternans in Patients With Heart Failure Treated Wih Sacubitril-Valsartan

Overview

The aim of this study is to know if the Sacubitril-Valsartan treatment improves the T-wave alternans in those patients that begin its treatment, which would indirectly show a lower risk of malignant ventricular arrythmias.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 15, 2020

Detailed Description

Sacubitril-Valsartan has shown to reduce sudden death in its principal clinical trial, PARADIGM-HF. A T wave alternans (TWA) is an electrophysiological phenomenon that acts as an independent predictor of sudden death and ventricular arrhythmias in postinfarct myocardial. TWA is measured by using a special software and electrodes during a treadmill test, that analyse small changes in the microvolt of the T wave consecutive with a complex algorithm in three dimensions. The TWA could be negative (normal), positive (pathological) or indeterminate. If a TWA is pathological it reflects an electric instability in depolarization. Our hypothesis is that the treatment with Sacubitril-Valsartan in heart failure patients with reduced ejection fraction, could improved the TWA.

Interventions

  • Drug: Sacubitril-Valsartan
    • After signing the Informed Consent, in the shortest possible time, the study investigator will carry out an ergometric test for the T-wave alternans (TWA) while still taking the basal medication. The patient will also sign the prototype Informed Consent for carrying out a stress test on a treadmill. It will also be carried out a basal life quality questionnaire, an analytical determination and a colour doppler echocardiography.

Arms, Groups and Cohorts

  • Sacubitril-Valsartan cohort
    • Patients with left systolic disfunction (left ventricle ejection fraction<40%) heart failure and diagnosed with grade II heart failure that have been treated with an ACE or ARA II+betablocker at stable doses during the last 4 weeks and after being evaluated by the cardiologist start Sacubitril-Valsartan treatment.

Clinical Trial Outcome Measures

Primary Measures

  • Analyze the changes in the T-wave alternans
    • Time Frame: Up to 6 months after the beginning of the Sacubitril-Valsartan treatment
    • Comparison of the results in the same patient just before the beginning of the Sacubitril-Valsartan pharmacological treatment versus 6 months after its beginning, in patients with grade II heart failure and left systolic disfunction (left ventricle ejection fraction<40%).

Secondary Measures

  • Evaluate the results in the life quality questionnaire.
    • Time Frame: Up to 6 months after the beginning of the Sacubitril-Valsartan treatment
    • Comparison of the life quality questionnaires results before and after the Sacubitril-Valsartan treatment.
  • Study the levels of the n-terminal type B natriuretic propeptide
    • Time Frame: Up to 6 months after the beginning of the Sacubitril-Valsartan treatment
    • Comparison of the n-terminal type B natriuretic propeptide levels before and after the Sacubitril-Valsartan treatment.
  • Evaluate the echocardiographic results
    • Time Frame: Up to 6 months after the beginning of the Sacubitril-Valsartan treatment
    • The echocardiographic results will be assessed by a combination of the measurement of the parameters: left ventricular ejection fraction (LVEF), left ventricular end-diastolic volume (LVEDV), left ventricular end systolic volume (LVESV) and left ventricle diastolic function, that will be compared before and after the Sacubitril-Valsartan treatment to evaluate its effect in patients with heart failure.

Participating in This Clinical Trial

Inclusion Criteria

  • Adults from 18 to 80 years old. – Patients with grade II heart failure according to the New York Heart Association (NYHA). – Left systolic disfunction: left ventricle ejection fraction<40% – NT-proBNP > 600 pg/ml (or > 100 pg/ml in the case the patients has been hospitalised during the last year. – Treated with ACE or ARA II+betablocker at stable doses during the prior 4 weeks to the beginning of the study. Exclusion Criteria:

  • Previously treated with Sacubitril-Valsartan. – Allergy or intolerance to ARA II. – Systolic blood pressure < 100 mmHG at inclusion. – Glomerular Filtration <35 ml / min / 1.73 m2 of body surface. – Level of potassium > 5,4 mEq/l. – Impossibility to walk on a treadmill. – Record of recovered sudden death or documented ventricular tachycardia. – Carrier of an automatic implantable defibrillator.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
  • Collaborator
    • Agencia Sanitaria Bajo Guadalquivir
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Antonio José Fernández Romero, Dr, Principal Investigator, Hospital de Alta Resolución de Utrera
    • Antonio José Fernández Romero, Dr, Study Chair, Hospital de Alta Resolución de Utrera
  • Overall Contact(s)
    • Antonio José Fernández Romero, Dr, 955 00 80 00, ajfr32@gmail.com

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