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NCT04127162 Clinical Trial

Heart Failure Decompensation And In-Hospital Mortality

Chronic Heart Failure Clinical Trial

Official title:
Short-Period Temporal Dispersion Repolarization Markers and In-Hospital Mortality in Decompensated Heart Failure: A Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04127162
Other study ID # CHF_NTproBNP
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 2019
Est. completion date April 2020

Study information
Verified date October 2019
Source University of Roma La Sapienza
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Background and objectives Heart failure is a leading cause of morbidity and mortality worldwide and it is a major cause of emergency department access for cardiovascular disease patients. Aim of this study is to identify the markers, based on short-term temporal repolarization dispersion, capable to individuate decompensated chronic heart failure (CHF) patients at high mortality risk.

Method: We will obtain the following variables from ECG monitor, via mobile phone, during 5-minute recordings in decompensated CHF patients: RR, QT end (QTe), QT peak (QTp) and T peak to T end (Te) and we calculated mean, standard deviation (SD) and normalized index (N).

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date April 2020
Est. primary completion date March 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria:

- at least one symptom or sign compatible with a decompensation and/or a previous documented history of CHF

Exclusion Criteria:

- pneumonia

- pulmonary embolism

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Roma La Sapienza

Outcome
Type Measure Description Time frame Safety issue
Primary Mortality in-hospital mortality in decompensated heart failure patients 3 months
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