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

• Conditions: Heart Failure
• Interventions: Drug: Sacubitril-Valsartan

• Registration Number: NCT04185103
• Lead Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Brief Summary

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.

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.

Study Timeline

• Study Start: 2019-10-15
• Study First Submitted: 2019-11-12
• Status Verified: 2019-12
• Study First Submitted QC: 2019-12-03
• Last Update Submitted: 2019-12-03
• Study First Posted: 2019-12-04
• Last Update Posted: 2019-12-04
• Primary Completion: 2020-11-15
• Study Completion: 2020-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sacubitril-Valsartan cohort	Sacubitril-Valsartan	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.

Primary Outcome Measures

Name	Time	Method
Analyze the changes in the T-wave alternans	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 Outcome Measures

Name	Time	Method
Study the levels of the n-terminal type B natriuretic propeptide	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	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.
Evaluate the results in the life quality questionnaire.	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.

Trial Locations

Locations (4)

Hospital de Alta Resolución de Utrera; 🇪🇸 Utrera, Sevilla, Spain

Hospital de Alta Resolución de Sierra Norte; 🇪🇸 Constantina, Seville, Spain

Hospital de Alta Resolución de Écija; 🇪🇸 Écija, Seville, Spain

Hospital de Alta Resolución de Lebrija; 🇪🇸 Lebrija, Seville, Spain