Heart Failure Decompensation And In-Hospital Mortality | NCT04127162

Studies
Heart Failure Decompensation And In-Hospital Mortality

NCT04127162

Sponsor

University of Roma La Sapienza

Status

Unknown status

Last Update Posted

Oct 15, 2019Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Chronic Heart Failure
Decompensated Heart Failure
Morality

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2019Estimated

Primary Completion Date

Mar 2020Estimated

Completion Date

Apr 2020Estimated

First Submitted Date

Oct 13, 2019

First Submission Date that Met QC Criteria

Oct 14, 2019

First Posted Date

Oct 15, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 14, 2019

Last Update Posted Date

Oct 15, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Gianfranco Piccirillo, professor, University of Roma La SapienzaPrincipal Investigator

Lead Sponsor

University of Roma La SapienzaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Month

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37510828	Derived	Moscucci F, Sciomer S, Maffei S, Meloni A, Lospinuso I, Carnovale M, Corrao A, Di Diego I, Caltabiano C, Mezzadri M, Mattioli AV, Gallina S, Rossi P, Magri D, Piccirillo G. Sex Differences in Repolarization Markers: Telemonitoring for Chronic Heart Failure Patients. J Clin Med. 2023 Jul 16;12(14):4714. doi: 10.3390/jcm12144714.
33382121

Label	Type	Description	Intervention Names
alive
dead