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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-15

Study Completion Date

2020-12-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Heart Failure

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Sacubitril-Valsartan

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No