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

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Status: Unknown

Conditions: Heart Failure

Treatments: Drug: Sacubitril-Valsartan

Study type: Observational

Funder types: Other

Identifiers

NCT04185103

FIS-SAC-2018-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

20 participants in 1 patient group

Sacubitril-Valsartan cohort

Description:

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.

Treatment:

Drug: Sacubitril-Valsartan