Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2026-02-01 @ 8:04 PM
Study NCT ID:
NCT04185103
Status:
UNKNOWN
Last Update Posted:
2019-12-04
First Post:
2019-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Changes in the T-wave Alternans in Patients With Heart Failure Treated Wih Sacubitril-Valsartan
Sponsor:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Organization:
Study Overview
Official Title:
Changes in the T-wave Alternans in Patients With Heart Failure Treated Wih Sacubitril-Valsartan
Status:
UNKNOWN
Status Verified Date:
2019-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: