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| Name | Class |
|---|---|
| Agencia Sanitaria Bajo Guadalquivir | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sacubitril-Valsartan | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Analyze the changes in the T-wave alternans | 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%). | Up to 6 months after the beginning of the Sacubitril-Valsartan treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the results in the life quality questionnaire. | Comparison of the life quality questionnaires results before and after the Sacubitril-Valsartan treatment. | Up to 6 months after the beginning of the Sacubitril-Valsartan treatment |
| Study the levels of the n-terminal type B natriuretic propeptide |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with heart failure that meet all of the following criteria and none of the exclusion criteria.
The selection of patients to be included in the study will be made in accordance to the Sacubitril-Valsartan data sheet.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonio José Fernández Romero, Dr | Contact | 955 00 80 00 | ajfr32@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Antonio José Fernández Romero, Dr | Hospital de Alta Resolución de Utrera | Principal Investigator |
| Antonio José Fernández Romero, Dr | Hospital de Alta Resolución de Utrera | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Alta Resolución de Utrera | Recruiting | Utrera | Sevilla | 41710 | Spain |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C549068 | sacubitril and valsartan sodium hydrate drug combination |
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|
Comparison of the n-terminal type B natriuretic propeptide levels before and after the Sacubitril-Valsartan treatment. |
| Up to 6 months after the beginning of the Sacubitril-Valsartan treatment |
| Evaluate the echocardiographic results | 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. | Up to 6 months after the beginning of the Sacubitril-Valsartan treatment |
| Hospital de Alta Resolución de Sierra Norte | Not yet recruiting | Constantina | Seville | 41450 | Spain |
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| Hospital de Alta Resolución de Écija | Active, not recruiting | Écija | Seville | 41400 | Spain |
| Hospital de Alta Resolución de Lebrija | Active, not recruiting | Lebrija | Seville | 41740 | Spain |