Status:

COMPLETED

Determination of Diastolic Dysfunction by Single Lead Electrocardiogram

Lead Sponsor:

I.M. Sechenov First Moscow State Medical University

Conditions:

Diastolic Function

Eligibility:

All Genders

18-90 years

Brief Summary

It is a prospective, controlled, single-center, non-randomized, observational study. From September 2019 to December 2020, the study plans to prospectively include 400 patients aged 18 to 90 years. ...

Detailed Description

It is a prospective, controlled, single-center, non-randomized, observational study. From September 2019 to December 2020, the study plans to prospectively include 400 patients aged 18 to 90 years. ...

Eligibility Criteria

Inclusion

  • The presence of written informed consent of the patient to participate in the study
  • Age from 18 years to 90 years
  • Outpatient treatment and / or hospitalization in a research center

Exclusion

  • Reluctance of the patient to participate in the study
  • Poor quality ECG recording on a single-channel ECG monitor
  • Poor visualization of the heart during echocardiographic study
  • Acute psychotic reactions that arose during research
  • An exacerbation of chronic diseases requiring treatment tactics for the patient and preventing his further participation in the study.
  • Non-inclusion criteria:
  • The presence of conduction disturbances in patients that impede ECG analysis (WPW syndrome, sinoatrial block of degrees 2 and 3, atrioventricular block 3 degrees, complete block of the left bundle branch block, complete block of the right bundle branch block)
  • Conditions that can impair ECG recording quality (Parkinson's disease, essential tremor)
  • The inability to assess diastolic function during echocardiography
  • Mental illness
  • Diseases with an expected life expectancy of less than 2 years
  • Patients with diffuse hypokinesis of the left ventricle with a reduced ejection fraction (less than 30%)
  • Patients with a pacemaker installed

Key Trial Info

Start Date :

September 1 2019

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

August 29 2021

Estimated Enrollment :

400 Patients enrolled

Trial Details

Trial ID

NCT04474639

Start Date

September 1 2019

End Date

August 29 2021

Last Update

August 31 2021

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I.M. Sechenov First Moscow State Medical University (Sechenov University)

Moscow, Russia