Chronic Heart FailureNCT04127162
Heart Failure Decompensation And In-Hospital Mortality
An observational study of Chronic Heart Failure and Decompensated Heart Failure, run by University of Roma La Sapienza.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Chronic Heart Failure, Decompensated Heart Failure, Morality
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Dec 2019to Apr 2020
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: decompensated heart failure patients admitted to the emergency department with dyspnea and other clinical signs of heart failure.
Who may be able to join
- at least one symptom or sign compatible with a decompensation and/or a previous documented history of CHF
Who cannot join
- pneumonia
- pulmonary embolism
About this study
Official title: 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).
- Conditions
- Chronic Heart Failure, Decompensated Heart Failure, Morality
- Keywords
- Temporal Dispersion of Repolarization Phase, proBNP, QTVI, QT, Tpeak-Tend
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| alive | Not described | |
| dead | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
in-hospital mortality in decompensated heart failure patients
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study startDec 2019 (estimated)
- Primary completionMar 2020 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianfranco Piccirillo, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04127162
- Sponsor's protocol ID
- CHF_NTproBNP
- Status last verified
- Oct 2019
- First submitted
- 13 Oct 2019
- Last updated
- 15 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37510828Piccirillo 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.
PubMed 33382121Piccirillo 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.
PubMed 32560151
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Period Temporal Dispersion Repolarization Markers and In-Hospital Mortality in Decompensated Heart Failure: A Pilot Study
- ClinicalTrials.gov ID
- NCT04127162
- Acronym / sponsor ID
- CHF_NTproBNP
- Conditions
- Chronic Heart Failure, Decompensated Heart Failure, Morality
- Keywords
- Temporal Dispersion of Repolarization Phase, proBNP, QTVI, QT, Tpeak-Tend
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Dec 2019 (estimated)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 15 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| alive | – | – |
| dead | – | – |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- decompensated heart failure patients admitted to the emergency department with dyspnea and other clinical signs of heart failure.
Key inclusion criteria (1 listed)
- at least one symptom or sign compatible with a decompensation and/or a previous documented history of CHF
Key exclusion criteria (2 listed)
- pneumonia
- pulmonary embolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: 3 months
in-hospital mortality in decompensated heart failure patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
- Derived from this study: PubMed 37510828Moscucci 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.
- Derived from this study: PubMed 33382121Piccirillo 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.
- Derived from this study: PubMed 32560151Piccirillo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Heart Failure and Decompensated Heart Failure, run by University of Roma La Sapienza.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04127162, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2019.