Heart Failure Decompensation And In-Hospital Mortality

NCT04127162 | Unknown

• 1 other identifier: CHF_NTproBNP
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Chronic Heart Failure; Decompensated Heart Failure; Morality

Keywords

Temporal Dispersion of Repolarization Phase; proBNP; QTVI; QT; Tpeak-Tend

Outcome Measures

Primary Outcomes (1)

• Mortality

  in-hospital mortality in decompensated heart failure patients

  3 months

Study Arms (2)

alive

dead

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• pneumonia
• pulmonary embolism

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Related Publications (3)

• 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.

  PMID: 37510828 DERIVED

• Piccirillo G, Moscucci F, Bertani G, Lospinuso I, Sabatino T, Zaccagnini G, Crapanzano D, Diego ID, Corrao A, Rossi P, Magri D. Short-period temporal repolarization dispersion in subjects with atrial fibrillation and decompensated heart failure. Pacing Clin Electrophysiol. 2021 Feb;44(2):327-333. doi: 10.1111/pace.14158. Epub 2021 Jan 12.

  PMID: 33382121 DERIVED

• Piccirillo G, Moscucci F, Bertani G, Lospinuso I, Mastropietri F, Fabietti M, Sabatino T, Zaccagnini G, Crapanzano D, Di Diego I, Corrao A, Rossi P, Magri D. Short-Period Temporal Dispersion Repolarization Markers Predict 30-Days Mortality in Decompensated Heart Failure. J Clin Med. 2020 Jun 16;9(6):1879. doi: 10.3390/jcm9061879.

  PMID: 32560151 DERIVED

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: October 13, 2019
• First Posted: October 15, 2019
• Study Start: December 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: April 1, 2020
• Last Updated: October 15, 2019

Record last verified: 2019-10