Tako Tsubo CardiomyopathySTRESSNCT07604467
The Role of CD34+ Stem Cells in the Pathogenesis of Takotsubo Syndrome
An observational study of Tako Tsubo Cardiomyopathy and Microvascular Dysfunction, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
The underlying mechanisms of microvascular dysfunction in Takotsubo cardiomyopathy remain incompletely understood. As CD34+ cells are essential to coronary microvascular homeostasis we will investigate the potential association between CD34+ cell count and changes in left ventricular function in patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tako Tsubo Cardiomyopathy, Microvascular Dysfunction
- How many people
- 40 participants
- Where
- 1 siteSlovenia
- Study dates
- 6 Sep 2021to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients, predominantly females, with cardiovascular risk factors.
Who may be able to join
- Minimum age 18 years
- Established TTS per InterTak registry criteria
- Signed consent form
Who cannot join
- Patients under the age of 18 years
- Ischemic heart disease with at least one complete total occlusion
- Other concurrent cardiomyopathies
- Active infectious myocarditis
- obstructive coronary artery disease
- Previous hospital stay due to acute coronary syndrome (myocardial infarction) in the last 6 months before TTS acute event
Show all 13Show fewer
- Previous interventional coronary artery procedure in the last 6 months before TTS acute event
- Significant valvular heart disease
- Significant peripheral artery occlusive disease
- Active or remitted hematologic malignancy
- Patients receiving immunosuppressive therapy
- Significant comorbiditeis affecting patients survival (malignancy)
- Failure to obtain freely given, informed consent form.
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
Advanced Heart Failure and Transplantation Program, Department of Cardiology, UMC Ljubljana, Slovenia
Ljubljana, Ljubljana, 1000
About this study
Official title: Effects of CD34+ Stem Cells on Left Ventricular Dysfunction Among Patients With Takotsubo Syndrome
The underlying mechanisms of microvascular dysfunction in Takotsubo cardiomyopathy remain incompletely understood. As CD34+ cells are essential to coronary microvascular homeostasis we will investigate the potential association between CD34+ cell count and changes in left ventricular function in patients with Takotsubo cardiomyopathy at baseline and 6-month follow-up.
Read the detailed description
Takotsubo syndrome presents with a transient non-ischemic acute heart failure and relatively fast recovery of myocardial contractility. This medical condition is often precipitated by a previous trigger, such as physical or emotional stress. However, in approximately one-third of Takotsubo patients, the trigger remains unidentified. In terms of acute clinical presentation, Takotsubo patients with and without acute coronary syndrome-related symptoms have been recognized. Early recognition of the latter group is challenging due to the lack of clear indication for transthoracic echocardiography and coronary angiography with left ventriculography in this patient cohort, representing the gold standard in diagnostics of Takotsubo patients. Therefore, the prevalence of Takotsubo patients without acute coronary syndrome-related symptoms appears to be underestimated. In addition, novel data reveal that both short- and long-term prognoses in Takotsubo patients are comparable to the prognosis in acute coronary syndrome patients. Furthermore, chronic heart failure has been recognized in a subgroup of Takotsubo patients. To sum up, Takotsubo syndrome represents a heterogeneous medical condition, with a potential for adverse outcomes. This calls for new approaches to the diagnostics and treatment of this patient population.
Coronary microvascular dysfunction has been proposed as a crucial pathophysiological mechanism underlying Takotsubo pathogenesis, including the left ventricular dysfunction at acute episode and the degree/rate of left ventricular contractility improvement. As CD34+ cells are essential to coronary microvascular homeostasis we speculated on potential association between CD34+ cell count and changes in left ventricular function in patients with Takotsubo cardiomyopathy at baseline and 6-month follow-up.
In this single-center prospective pilot cohort study we included 34 consecutive patients with Takotsubo cardiomyopathy treated at our center between September 2021 and January 2026. Patients with a history of malignancy and concurrent acute coronary syndrome-mimicking conditions (myocardial infarction, myocarditis, etc) were not considered for this analysis. Takotsubo cardiomyopathy diagnosis was established per InterTac Registry criteria. Patients were enrolled within 24h of admission and underwent comprehensive clinical examination, blood biochemical and hematological analysis, and echocardiography at baseline and 6-month follow-up. Additionally, we expect at least half of the enrolled patients to complete cardiac MRI scan at baseline and 6-month follow-up. CD34+ cell count was measured using Beckman-Coulter Navios EX flow cytometry with standard antibodies according to ISAGE protocol.
The study results might enhance undertsanding of the pathophgysiological mechanism underlying structural and functional myocardial recovery among Takotsubo patients. Also, the study outcomes might provide crucial context for justifying further research work on investigating potential therapeutic effects of CD34+ cells on myocardial contractility recovery among Takotsubo patients.
- Keywords
- Takotsubo syndrome, CD34+ stem cells, heart failure, microvascular dysfunction, cardiac contractility recovery
- Medical subject headings
- Takotsubo Cardiomyopathy, Heart Failure
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 |
|---|---|---|
| Takotsubo patients with preserved OR mildly reduced/reduced LVEF at acute event. | Takotsubo patients divided in subgroups based on preserved or mildly reduced/reduced LVEF at acute event. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery of left ventricular systolic function assessed by change in left ventricular ejection fraction (LVEF)
Change in LVEF (%), measured by transthoracic echocardiography using Biplane Simpson's method.
Measured: From enrollment to the end of observational period at 6-month follow-up.
Secondary outcomes (11)
Improvement in myocardial contractility and deformation assesed by change in left ventricular global longitudinal strain (LV GLS)
Change in LV GLS (%), measured by transthoracic echocardiography using speckle-tracking method.
Measured: From enrollment to the end of observational period at 6-month follow-up.
Reduction in left ventricular filling pressure assessed by change in early mitral inflow velocity (E-wave) and the average of the septal and lateral early diastolic mitral annular velocities ratio (E/e' average)
Change in E/e' average, calculated from transthoracic echocardiography by dividing the peak early mitral inflow velocity (E-wave) by the average of the septal and lateral early diastolic mitral annular velocities (e') obtained via tissue doppler imaging.
Measured: From enrollment to the end of observational period at 6-month follow-up.
Recovery of impaired myocardial relaxation assessed by change in peak early mitral inflow velocity and peak atrial contraction wave velocity ratio (E/A ratio)
Change in E/A ratio, calculated from transthoracic echocardiography by dividing the peak early mitral inflow velocity (E-wave) by the peak atrial contraction velocity (A-wave), both measured via pulsed-wave Doppler in the apical four-chamber view.
Measured: From enrollment to the end of observational period at 6-month follow-up.
Reduction in pulmonary artery systolic pressure assessed by change in tricuspid regurgitation maximum gradient (TR max gradient)
Change in TR max gradient (mmHg), measured using transthoracic echocardiography by applying continuous wave (CW) doppler to the TR jet to determine the peak velocity, then applying the modified Bernoulli equation.
Measured: From enrollment to the end of observational period at 6-month follow-up.
Reduction in left ventricular size assessed by left ventricular end-diastolic volume index (LVEDVi)
Change in LVEDVi (mL/m2), calculated from transthoracic echocardiography using Biplane Simpson's method and indexed to body surface area.
Measured: From enrollment to the end of observational period at 6-month follow-up.
Reduction in left ventricular wall thickness assessed by posterior (inferolateral) wall diameter (PWd) and interventricular septal diameter (IVSd)
Change in PWd (mm) and IVSd (mm), assessed by transthoracic echocardiography using parasternal long-axis view.
Measured: From enrollment to the end of observational period at 6-month follow-up.
Improvement in right ventricular systolic function assessed by tricuspid annular plane systolic excursion (TAPSE)
Change in TAPSE (mm), assessed by transthoracic echocardiography and measured in the apical 4-chamber view using M-mode placed at the lateral tricuspid annulus.
Measured: From enrollment to the end of observational period at 6-month follow-up.
Reduction in the extent of myocardial oedema assessed by cardiac magnetic resonance imaging
Change in the extent of myocardial oedema, assessed by cardiac magnetic resonance imaging scan using T2-weighted imaging and T2-mapping (T2 relaxation times in miliseconds).
Measured: Baseline and 6-month follow-up.
Remnants of cardiac fibrosis assessed by the extent of late gadolinium enhancement (LGE)
Change in the extent of myocardial LGE (% of left ventricular mass), quantified by cardiac magnetic resonance (CMR).
Measured: Baseline, 6-month follow-up.
Recovery of coronary microvascular dysfunction assessed by change in angiogenesis-related biomarkers
Change in angiogenesis-related biomarker panel composite score, measured using a Luminex multiplex immunoassay.
Measured: From enrollment to the end of observational period at 6-month follow-up.
Reduction in cardiac congestion assessed by change in serum levels of natriuretic peptides (NT-proBNP)
Change in serum levels of NT-proBNP (ng/L), measured in blood sample by serum biochemical analysis.
Measured: From enrollment to the end of observational period at 6-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start6 Sep 2021
- Primary completion30 Jun 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Tako Tsubo CardiomyopathyStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregor Poglajen, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07604467
- Sponsor's protocol ID
- 0120-118/2021/3
- Acronym
- STRESS
- Status last verified
- Nov 2026
- First submitted
- 17 May 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rai B, Shukla J, Henry TD, Quesada O. Angiogenic CD34 Stem Cell Therapy in Coronary Microvascular Repair-A Systematic Review. Cells. 2021 May 8;10(5):1137. doi: 10.3390/cells10051137.
PubMed 34066713Eerdekens R, El Farissi M, De Maria GL, Shetrit A, Sykes R, Ekenback C, Persson J, Spaak J, Couch LS, Alfonso F, Rivero F, Gonzalo N, Escaned J, Nunez Gil IJ, Cruz OV, Shamir RA, Freund O, Vanderheyden M, Belmonte M, Barbato E, Tonino PAL, Banning A, Solberg OG, Berry C, Fearon WF, Zimmermann FM. Prognostic Value of Microvascular Function in Takotsubo Syndrome: A Pooled Analysis of Individual Patient Data. JACC Cardiovasc Interv. 2025 Jul 14;18(13):1646-1656. doi: 10.1016/j.jcin.2025.05.028. Epub 2025 May 22.
PubMed 40415182Almendro-Delia M, Lopez-Flores L, Uribarri A, Vedia O, Blanco-Ponce E, Lopez-Flores MDC, Rivas-Garcia AP, Fernandez-Cordon C, Sionis A, Martin-Garcia AC, Vazirani R, Corbi-Pascual M, Salamanca J, Perez-Castellanos A, Martinez-Selles M, Becerra VM, Aritza-Conty D, Lopez-Pais J, Guillen-Marzo M, Lluch-Requerey C, Garcia-Rubira JC, Nunez-Gil IJ; RETAKO Investigators. Recovery of Left Ventricular Function and Long-Term Outcomes in Patients With Takotsubo Syndrome. J Am Coll Cardiol. 2024 Sep 24;84(13):1163-1174. doi: 10.1016/j.jacc.2024.05.075.
PubMed 39293882Shaikh N, Sardar M, Jacob A, Alagusundaramoorthy SS, Eng M, Checton J, Shah A. Possible predictive factors for recovery of left ventricular systolic function in Takotsubo cardiomyopathy. Intractable Rare Dis Res. 2018 May;7(2):100-105. doi: 10.5582/irdr.2018.01042.
PubMed 29862151Templin C, Ghadri JR, Diekmann J, Napp LC, Bataiosu DR, Jaguszewski M, Cammann VL, Sarcon A, Geyer V, Neumann CA, Seifert B, Hellermann J, Schwyzer M, Eisenhardt K, Jenewein J, Franke J, Katus HA, Burgdorf C, Schunkert H, Moeller C, Thiele H, Bauersachs J, Tschope C, Schultheiss HP, Laney CA, Rajan L, Michels G, Pfister R, Ukena C, Bohm M, Erbel R, Cuneo A, Kuck KH, Jacobshagen C, Hasenfuss G, Karakas M, Koenig W, Rottbauer W, Said SM, Braun-Dullaeus RC, Cuculi F, Banning A, Fischer TA, Vasankari T, Airaksinen KE, Fijalkowski M, Rynkiewicz A, Pawlak M, Opolski G, Dworakowski R, MacCarthy P, Kaiser C, Osswald S, Galiuto L, Crea F, Dichtl W, Franz WM, Empen K, Felix SB, Delmas C, Lairez O, Erne P, Bax JJ, Ford I, Ruschitzka F, Prasad A, Luscher TF. Clinical Features and Outcomes of Takotsubo (Stress) Cardiomyopathy. N Engl J Med. 2015 Sep 3;373(10):929-38. doi: 10.1056/NEJMoa1406761.
PubMed 26332547
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of CD34+ Stem Cells on Left Ventricular Dysfunction Among Patients With Takotsubo Syndrome
- ClinicalTrials.gov ID
- NCT07604467
- Acronym / sponsor ID
- STRESS / 0120-118/2021/3
- Keywords
- Takotsubo syndrome, CD34+ stem cells, heart failure, microvascular dysfunction, cardiac contractility recovery
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 6 Sep 2021 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 May 2026 (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.
The underlying mechanisms of microvascular dysfunction in Takotsubo cardiomyopathy remain incompletely understood. As CD34+ cells are essential to coronary microvascular homeostasis we will investigate the potential association between CD34+ cell count and changes in left ventricular function in patients with Takotsubo cardiomyopathy at baseline and 6-month follow-up.
Detailed description
Takotsubo syndrome presents with a transient non-ischemic acute heart failure and relatively fast recovery of myocardial contractility. This medical condition is often precipitated by a previous trigger, such as physical or emotional stress. However, in approximately one-third of Takotsubo patients, the trigger remains unidentified. In terms of acute clinical presentation, Takotsubo patients with and without acute coronary syndrome-related symptoms have been recognized. Early recognition of the latter group is challenging due to the lack of clear indication for transthoracic echocardiography and coronary angiography with left ventriculography in this patient cohort, representing the gold standard in diagnostics of Takotsubo patients. Therefore, the prevalence of Takotsubo patients without acute coronary syndrome-related symptoms appears to be underestimated. In addition, novel data reveal that both short- and long-term prognoses in Takotsubo patients are comparable to the prognosis in acute coronary syndrome patients. Furthermore, chronic heart failure has been recognized in a subgroup of Takotsubo patients. To sum up, Takotsubo syndrome represents a heterogeneous medical condition, with a potential for adverse outcomes. This calls for new approaches to the diagnostics and treatment of this patient population.
Coronary microvascular dysfunction has been proposed as a crucial pathophysiological mechanism underlying Takotsubo pathogenesis, including the left ventricular dysfunction at acute episode and the degree/rate of left ventricular contractility improvement. As CD34+ cells are essential to coronary microvascular homeostasis we speculated on potential association between CD34+ cell count and changes in left ventricular function in patients with Takotsubo cardiomyopathy at baseline and 6-month follow-up.
In this single-center prospective pilot cohort study we included 34 consecutive patients with Takotsubo cardiomyopathy treated at our center between September 2021 and January 2026. Patients with a history of malignancy and concurrent acute coronary syndrome-mimicking conditions (myocardial infarction, myocarditis, etc) were not considered for this analysis. Takotsubo cardiomyopathy diagnosis was established per InterTac Registry criteria. Patients were enrolled within 24h of admission and underwent comprehensive clinical examination, blood biochemical and hematological analysis, and echocardiography at baseline and 6-month follow-up. Additionally, we expect at least half of the enrolled patients to complete cardiac MRI scan at baseline and 6-month follow-up. CD34+ cell count was measured using Beckman-Coulter Navios EX flow cytometry with standard antibodies according to ISAGE protocol.
The study results might enhance undertsanding of the pathophgysiological mechanism underlying structural and functional myocardial recovery among Takotsubo patients. Also, the study outcomes might provide crucial context for justifying further research work on investigating potential therapeutic effects of CD34+ cells on myocardial contractility recovery among Takotsubo patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Takotsubo patients with preserved OR mildly reduced/reduced LVEF at acute event. | – | –Takotsubo patients divided in subgroups based on preserved or mildly reduced/reduced LVEF at acute event. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients, predominantly females, with cardiovascular risk factors.
Key inclusion criteria (3 listed)
- Minimum age 18 years
- Established TTS per InterTak registry criteria
- Signed consent form
Key exclusion criteria (13 listed)
- Patients under the age of 18 years
- Ischemic heart disease with at least one complete total occlusion
- Other concurrent cardiomyopathies
- Active infectious myocarditis
- obstructive coronary artery disease
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
Recovery of left ventricular systolic function assessed by change in left ventricular ejection fraction (LVEF)
Time frame: From enrollment to the end of observational period at 6-month follow-up.
Change in LVEF (%), measured by transthoracic echocardiography using Biplane Simpson's method.
11 secondary outcomes
Improvement in myocardial contractility and deformation assesed by change in left ventricular global longitudinal strain (LV GLS)
Time frame: From enrollment to the end of observational period at 6-month follow-up.
Reduction in left ventricular filling pressure assessed by change in early mitral inflow velocity (E-wave) and the average of the septal and lateral early diastolic mitral annular velocities ratio (E/e' average)
Time frame: From enrollment to the end of observational period at 6-month follow-up.
Recovery of impaired myocardial relaxation assessed by change in peak early mitral inflow velocity and peak atrial contraction wave velocity ratio (E/A ratio)
Time frame: From enrollment to the end of observational period at 6-month follow-up.
Reduction in pulmonary artery systolic pressure assessed by change in tricuspid regurgitation maximum gradient (TR max gradient)
Time frame: From enrollment to the end of observational period at 6-month follow-up.
Reduction in left ventricular size assessed by left ventricular end-diastolic volume index (LVEDVi)
Time frame: From enrollment to the end of observational period at 6-month follow-up.
Reduction in left ventricular wall thickness assessed by posterior (inferolateral) wall diameter (PWd) and interventricular septal diameter (IVSd)
Time frame: From enrollment to the end of observational period at 6-month follow-up.
Improvement in right ventricular systolic function assessed by tricuspid annular plane systolic excursion (TAPSE)
Time frame: From enrollment to the end of observational period at 6-month follow-up.
Reduction in the extent of myocardial oedema assessed by cardiac magnetic resonance imaging
Time frame: Baseline and 6-month follow-up.
Remnants of cardiac fibrosis assessed by the extent of late gadolinium enhancement (LGE)
Time frame: Baseline, 6-month follow-up.
Recovery of coronary microvascular dysfunction assessed by change in angiogenesis-related biomarkers
Time frame: From enrollment to the end of observational period at 6-month follow-up.
Reduction in cardiac congestion assessed by change in serum levels of natriuretic peptides (NT-proBNP)
Time frame: From enrollment to the end of observational period at 6-month follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Background: PubMed 34066713Rai B, Shukla J, Henry TD, Quesada O. Angiogenic CD34 Stem Cell Therapy in Coronary Microvascular Repair-A Systematic Review. Cells. 2021 May 8;10(5):1137. doi: 10.3390/cells10051137.
- Background: PubMed 40415182Eerdekens R, El Farissi M, De Maria GL, Shetrit A, Sykes R, Ekenback C, Persson J, Spaak J, Couch LS, Alfonso F, Rivero F, Gonzalo N, Escaned J, Nunez Gil IJ, Cruz OV, Shamir RA, Freund O, Vanderheyden M, Belmonte M, Barbato E, Tonino PAL, Banning A, Solberg OG, Berry C, Fearon WF, Zimmermann FM. Prognostic Value of Microvascular Function in Takotsubo Syndrome: A Pooled Analysis of Individual Patient Data. JACC Cardiovasc Interv. 2025 Jul 14;18(13):1646-1656. doi: 10.1016/j.jcin.2025.05.028. Epub 2025 May 22.
- Background: PubMed 39293882Almendro-Delia M, Lopez-Flores L, Uribarri A, Vedia O, Blanco-Ponce E, Lopez-Flores MDC, Rivas-Garcia AP, Fernandez-Cordon C, Sionis A, Martin-Garcia AC, Vazirani R, Corbi-Pascual M, Salamanca J, Perez-Castellanos A, Martinez-Selles M, Becerra VM, Aritza-Conty D, Lopez-Pais J, Guillen-Marzo M, Lluch-Requerey C, Garcia-Rubira JC, Nunez-Gil IJ; RETAKO Investigators. Recovery of Left Ventricular Function and Long-Term Outcomes in Patients With Takotsubo Syndrome. J Am Coll Cardiol. 2024 Sep 24;84(13):1163-1174. doi: 10.1016/j.jacc.2024.05.075.
- Background: PubMed 29862151Shaikh N, Sardar M, Jacob A, Alagusundaramoorthy SS, Eng M, Checton J, Shah A. Possible predictive factors for recovery of left ventricular systolic function in Takotsubo cardiomyopathy. Intractable Rare Dis Res. 2018 May;7(2):100-105. doi: 10.5582/irdr.2018.01042.
- Background: PubMed 26332547Templin C, Ghadri JR, Diekmann J, Napp LC, Bataiosu DR, Jaguszewski M, Cammann VL, Sarcon A, Geyer V, Neumann CA, Seifert B, Hellermann J, Schwyzer M, Eisenhardt K, Jenewein J, Franke J, Katus HA, Burgdorf C, Schunkert H, Moeller C, Thiele H, Bauersachs J, Tschope C, Schultheiss HP, Laney CA, Rajan L, Michels G, Pfister R, Ukena C, Bohm M, Erbel R, Cuneo A, Kuck KH, Jacobshagen C, Hasenfuss G, Karakas M, Koenig W, Rottbauer W, Said SM, Braun-Dullaeus RC, Cuculi F, Banning A, Fischer TA, Vasankari T, Airaksinen KE, Fijalkowski M, Rynkiewicz A, Pawlak M, Opolski G, Dworakowski R, MacCarthy P, Kaiser C, Osswald S, Galiuto L, Crea F, Dichtl W, Franz WM, Empen K, Felix SB, Delmas C, Lairez O, Erne P, Bax JJ, Ford I, Ruschitzka F, Prasad A, Luscher TF. Clinical Features and Outcomes of Takotsubo (Stress) Cardiomyopathy. N Engl J Med. 2015 Sep 3;373(10):929-38. doi: 10.1056/NEJMoa1406761.
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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 Tako Tsubo Cardiomyopathy and Microvascular Dysfunction, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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 13 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: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. 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 Slovenia. 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?
This study is still under way. Results are not available in the source record yet.
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?
Recovery of left ventricular systolic function assessed by change in left ventricular ejection fraction (LVEF) (time frame: From enrollment to the end of observational period at 6-month follow-up.). 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 NCT07604467, which also lists 5 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 4 Nov 2026.