Changes in the T-wave Alternans in Patients With Heart Failure Treated Wih Sacubitril-Valsartan

Heart Failure Clinical Trial

Official title:

Changes in the T-wave Alternans in Patients With Heart Failure Treated Wih Sacubitril-Valsartan

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04185103
• Other study ID #: FIS-SAC-2018-02
• Status: Recruiting
• Start date: October 15, 2019
• Est. completion date: December 15, 2020

Study information

• Verified date: December 2019
• Source: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Contact: Antonio José Fernández Romero, Dr
• Phone: 955 00 80 00
• Email: ajfr32[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 15, 2020
• Est. primary completion date: November 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital de Alta Resolución de Sierra Norte	Constantina	Seville
Spain	Hospital de Alta Resolución de Écija	Écija	Seville
Spain	Hospital de Alta Resolución de Lebrija	Lebrija	Seville
Spain	Hospital de Alta Resolución de Utrera	Utrera	Sevilla

Sponsors (2)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla	Agencia Sanitaria Bajo Guadalquivir

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Study the levels of the n-terminal type B natriuretic propeptide	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
Secondary	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