Clinical trial NCT04185103: Changes in the T-wave Alternans in Patients With Heart Failure Treated Wih Sacubitril-Valsartan
Official title: Changes in the T-wave Alternans in Patients With Heart Failure Treated Wih Sacubitril-Valsartan
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Keywords: Heart Failure
Sacubitril-Valsartan
T-wave changes alternans
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
Collaborators: name: Agencia Sanitaria Bajo Guadalquivir
First posted: 2019-12-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility 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.

Primary outcomes:
measure: Analyze the changes in the T-wave alternans
timeFrame: Up to 6 months after the beginning of the Sacubitril-Valsartan treatment
Secondary outcomes:
measure: Evaluate the results in the life quality questionnaire.
timeFrame: Up to 6 months after the beginning of the Sacubitril-Valsartan treatment
measure: Study the levels of the n-terminal type B natriuretic propeptide
timeFrame: Up to 6 months after the beginning of the Sacubitril-Valsartan treatment
measure: Evaluate the echocardiographic results
timeFrame: Up to 6 months after the beginning of the Sacubitril-Valsartan treatment
Other outcomes:
Locations:
city: Utrera
country: Spain
facility: Hospital de Alta Resolución de Utrera
state: Sevilla
city: Constantina
country: Spain
facility: Hospital de Alta Resolución de Sierra Norte
state: Seville
city: Lebrija
country: Spain
facility: Hospital de Alta Resolución de Lebrija
state: Seville
city: Écija
country: Spain
facility: Hospital de Alta Resolución de Écija
state: Seville
Study officials:
affiliation: Hospital de Alta Resolución de Utrera
name: Antonio José Fernández Romero, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Alta Resolución de Utrera
name: Antonio José Fernández Romero, Dr
role: STUDY_CHAIR
References: