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

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.

Study Overview

• Status: Unknown
• Conditions: Heart Failure
• Intervention / Treatment: Drug: Sacubitril-Valsartan

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 Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• Spain
  • Sevilla
    • Utrera, Sevilla, Spain, 41710
      • Recruiting
      • Hospital de Alta Resolución de Utrera
      • Contact: Antonio José Fernández Romero; Phone Number: 955 00 80 00; Email: ajfr32@gmail.com
      • Principal Investigator: Antonio José Fernández Romero, Dr
      • Sub-Investigator: Rocío Picón Heras, Dr
  • Seville
    • Constantina, Seville, Spain, 41450
      • Not yet recruiting
      • Hospital de Alta Resolución de Sierra Norte
      • Contact: Dr
      • Contact: Raquel Solanilla Rodriguez, Dr; Phone Number: 665082050; Email: raquelsolanilla@hotmail.com
      • Principal Investigator: Raquel Solanilla Rodríguez, Dr
      • Sub-Investigator: Paula Escane Duarte, Dr
    • Lebrija, Seville, Spain, 41740
      • Active, not recruiting
      • Hospital de Alta Resolución de Lebrija
    • Écija, Seville, Spain, 41400
      • Active, not recruiting
      • Hospital de Alta Resolución de Ecija

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Collaborators: 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 record dates

Study Major Dates

• Study Start (Actual): October 15, 2019
• Primary Completion (Anticipated): November 15, 2020
• Study Completion (Anticipated): December 15, 2020

Study Registration Dates

• First Submitted: November 12, 2019
• First Submitted That Met QC Criteria: December 3, 2019
• First Posted (Actual): December 4, 2019

Study Record Updates

• Last Update Posted (Actual): December 4, 2019
• Last Update Submitted That Met QC Criteria: December 3, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Heart Failure; Sacubitril-Valsartan; T-wave changes alternans
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Valsartan; Sacubitril and valsartan sodium hydrate drug combination
• Other Study ID Numbers: FIS-SAC-2018-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No