Heart Failure Decompensation And In-Hospital Mortality

October 14, 2019 updated by: Gianfranco Piccirillo, University of Roma La Sapienza

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

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).

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

50

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

decompensated heart failure patients admitted to the emergency department with dyspnea and other clinical signs of heart failure.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
alive
dead

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 3 months
in-hospital mortality in decompensated heart failure patients
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

December 1, 2019

Primary Completion (ANTICIPATED)

March 1, 2020

Study Completion (ANTICIPATED)

April 1, 2020

Study Registration Dates

First Submitted

October 13, 2019

First Submitted That Met QC Criteria

October 14, 2019

First Posted (ACTUAL)

October 15, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 15, 2019

Last Update Submitted That Met QC Criteria

October 14, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHF_NTproBNP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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