Heart Failure
Conditions
Keywords
Heart Failure, Sacubitril-Valsartan, T-wave changes alternans
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.
Interventions
DRUGSacubitril-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.
Sponsors
Agencia Sanitaria Bajo Guadalquivir
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Spain
Contacts
Primary ContactAntonio José Fernández Romero, Dr
Outcome results
None listed