Trials / Unknown
UnknownNCT04185103
Changes in the T-wave Alternans in Patients With Heart Failure Treated Wih Sacubitril-Valsartan
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 20 (estimated)
- Sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 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. |
Timeline
- Start date
- 2019-10-15
- Primary completion
- 2020-11-15
- Completion
- 2020-12-15
- First posted
- 2019-12-04
- Last updated
- 2019-12-04
Locations
4 sites across 1 country: Spain
Source: ClinicalTrials.gov record NCT04185103. Inclusion in this directory is not an endorsement.