NCT04185103

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2019

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

November 12, 2019

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 4, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2020

Completed
Last Updated

December 4, 2019

Status Verified

December 1, 2019

Enrollment Period

1.1 years

First QC Date

November 12, 2019

Last Update Submit

December 3, 2019

Conditions

Heart Failure

Keywords

Heart FailureSacubitril-ValsartanT-wave changes alternans

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Evaluate the results in the life quality questionnaire.

    Up to 6 months after the beginning of 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

  • Evaluate the echocardiographic results

    Up to 6 months after the beginning of the Sacubitril-Valsartan treatment

Study Arms (1)

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

Interventions

Sacubitril-ValsartanDRUG

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.

Sacubitril-Valsartan cohort

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Previously treated with Sacubitril-Valsartan.
  • Allergy or intolerance to ARA II.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hospital de Alta Resolución de Utrera

Utrera, Sevilla, 41710, Spain

RECRUITING

Hospital de Alta Resolución de Sierra Norte

Constantina, Seville, 41450, Spain

NOT YET RECRUITING

Hospital de Alta Resolución de Écija

Écija, Seville, 41400, Spain

ACTIVE NOT RECRUITING

Hospital de Alta Resolución de Lebrija

Lebrija, Seville, 41740, Spain

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

sacubitril and valsartan sodium hydrate drug combination

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • 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

Central Study Contacts

Antonio José Fernández Romero, Dr

CONTACT

955 00 80 00ajfr32@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2019

First Posted

December 4, 2019

Study Start

October 15, 2019

Primary Completion

November 15, 2020

Study Completion

December 15, 2020

Last Updated

December 4, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

ES(4)