Changes in the T-wave Alternans in Patients With Heart Failure Treated Wih Sacubitril-Valsartan
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
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.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital de Alta Resolución de Utrera | Utrera | Sevilla | Spain | 41710 |
| 2 | Hospital de Alta Resolución de Sierra Norte | Constantina | Seville | Spain | 41450 |
| 3 | Hospital de Alta Resolución de Lebrija | Lebrija | Seville | Spain | 41740 |
| 4 | Hospital de Alta Resolución de Écija | Écija | Seville | Spain | 41400 |
Sponsors and Collaborators
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Agencia Sanitaria Bajo Guadalquivir
Investigators
- Principal Investigator: Antonio José Fernández Romero, Dr, Hospital de Alta Resolución de Utrera
- Study Chair: Antonio José Fernández Romero, Dr, Hospital de Alta Resolución de Utrera
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FIS-SAC-2018-02