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

F

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

Trial contacts and locations

4

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Central trial contact

Antonio José Fernández Romero, Dr

Data sourced from clinicaltrials.gov

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