Takotsubo CardiomyopathyNCT04684004
Hyperglycemia in Patients With Takotsubo Syndrome
An observational study of Takotsubo Cardiomyopathy, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial summary
Patients with Takotsubo cardiomiopathy (TTC) have over-inflammation and over-sympathetic tone. However, these conditions could cause higher rate of heart failure (HF) events and deaths at 2 years of follow-up. Conversely, hyperglycemia vs. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Takotsubo Cardiomyopathy
- What is being tested?
- To report number of HF events and deaths
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2013to 1 Jan 2019
- 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 75 years
- All sexes
- Adult, Older adult
Study population: The study population will be of patients with acute TTC event. The enrolled patients according to inclusion and exclusion criteria will be then divided in normoglycemics vs. hyperglycemics according to blood glucose values at hospital admission.
Who may be able to join
- acute onset of a cardiovascular event, usually associated with substernal chest pain, initially regarded as STEMI/evolving coronary syndrome;
- cardiac biomarker modifications (creatine kinase-MB and troponin I);
- systolic dysfunction, predominantly characterized by akinesia/hypokinesia of the mid-to-distal portion of the left ventricle (LV) chamber, with hyper-contractile basal LV.
Who cannot join
- patients with previous previous myocardial infarction;
- patients with previous TTC event;
- patients affected by chronic kidney, liver, and cerebrovascular diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Blood Glucose Values at Hospital Admission and Clinical Outcomes in Patients With Takotsubo Syndrome: Hyperglycemia Effects on Heart Failure Events and Mortality at 24 Months of Follow-up
Patients with Takotsubo cardiomiopathy (TTC) have over-inflammation and over-sympathetic tone. However, these conditions could cause higher rate of heart failure (HF) events and deaths at 2 years of follow-up. Conversely, hyperglycemia vs. normoglycemia could result in over expression of inflammatory markers and catecholamines thta could result in higher rate of HF and deaths at 2 years of follow-up in TTC patients.
- Conditions
- Takotsubo Cardiomyopathy
- Being tested
- To report number of HF events and deaths
- Medical subject headings
- Takotsubo Cardiomyopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
To report number of HF events and deathsOther
In these two cohorts of study authors will evaluate at 2 years of follow-up the number of HF events and of deaths.
| Study group | Role | What they receive |
|---|---|---|
| TTC patients with hyperglycemia | These patients will be hospitalized for TTC acute event. These patients will be characterized by higher blood glucose values at admission, and so defined as hyperglycemics. Receives: Other: To report number of HF events and deaths | |
| TTC patients with normoglycemia | These patients will be hospitalized for TTC acute event. These patients will be characterized by normal blood glucose values at admission, and so defined as normoglycemics. Receives: Other: To report number of HF events and deaths |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of HF events
To evaluate the number of HF events by clinical visits, telephonic interviews and hospital discharge schedules.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start1 Jan 2013
- Primary completion1 Jan 2017
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Takotsubo CardiomyopathyStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Celestino Sardu, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04684004
- Sponsor's protocol ID
- 02.12.20
- Status last verified
- Dec 2020
- First submitted
- 22 Dec 2020
- Last updated
- 28 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Paolisso P, Bergamaschi L, Rambaldi P, Gatta G, Foa A, Angeli F, Fabrizio M, Casella G, Barbieri M, Galie N, Marfella R, Pizzi C, Sardu C. Impact of Admission Hyperglycemia on Heart Failure Events and Mortality in Patients With Takotsubo Syndrome at Long-term Follow-up: Data From HIGH-GLUCOTAKO Investigators. Diabetes Care. 2021 Sep;44(9):2158-2161. doi: 10.2337/dc21-0433. Epub 2021 Jun 29.
PubMed 34187841
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Glucose Values at Hospital Admission and Clinical Outcomes in Patients With Takotsubo Syndrome: Hyperglycemia Effects on Heart Failure Events and Mortality at 24 Months of Follow-up
- ClinicalTrials.gov ID
- NCT04684004
- Acronym / sponsor ID
- 02.12.20
- Conditions
- Takotsubo Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 24 Dec 2020 (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.
Patients with Takotsubo cardiomiopathy (TTC) have over-inflammation and over-sympathetic tone. However, these conditions could cause higher rate of heart failure (HF) events and deaths at 2 years of follow-up. Conversely, hyperglycemia vs. normoglycemia could result in over expression of inflammatory markers and catecholamines thta could result in higher rate of HF and deaths at 2 years of follow-up in TTC patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TTC patients with hyperglycemia | – | Other: To report number of HF events and deathsThese patients will be hospitalized for TTC acute event. These patients will be characterized by higher blood glucose values at admission, and so defined as hyperglycemics. |
| TTC patients with normoglycemia | – | Other: To report number of HF events and deathsThese patients will be hospitalized for TTC acute event. These patients will be characterized by normal blood glucose values at admission, and so defined as normoglycemics. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population will be of patients with acute TTC event. The enrolled patients according to inclusion and exclusion criteria will be then divided in normoglycemics vs. hyperglycemics according to blood glucose values at hospital admission.
Key inclusion criteria (3 listed)
- acute onset of a cardiovascular event, usually associated with substernal chest pain, initially regarded as STEMI/evolving coronary syndrome;
- cardiac biomarker modifications (creatine kinase-MB and troponin I);
- systolic dysfunction, predominantly characterized by akinesia/hypokinesia of the mid-to-distal portion of the left ventricle (LV) chamber, with hyper-contractile basal LV.
Key exclusion criteria (3 listed)
- patients with previous previous myocardial infarction;
- patients with previous TTC event;
- patients affected by chronic kidney, liver, and cerebrovascular diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| To report number of HF events and deathsIn these two cohorts of study authors will evaluate at 2 years of follow-up the number of HF events and of deaths. | Other | TTC patients with hyperglycemia, TTC patients with normoglycemia |
Primary outcome
The number of HF events
Time frame: 12 months
To evaluate the number of HF events by clinical visits, telephonic interviews and hospital discharge schedules.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2020.
- Derived from this study: PubMed 34187841Paolisso P, Bergamaschi L, Rambaldi P, Gatta G, Foa A, Angeli F, Fabrizio M, Casella G, Barbieri M, Galie N, Marfella R, Pizzi C, Sardu C. Impact of Admission Hyperglycemia on Heart Failure Events and Mortality in Patients With Takotsubo Syndrome at Long-term Follow-up: Data From HIGH-GLUCOTAKO Investigators. Diabetes Care. 2021 Sep;44(9):2158-2161. doi: 10.2337/dc21-0433. Epub 2021 Jun 29.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Takotsubo Cardiomyopathy, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 28 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The number of HF events (time frame: 12 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 NCT04684004, which also lists 1 linked publication.
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 28 Dec 2020.