Takotsubo CardiomyopathyPLEASENCT04425785
Physical Exercise and Mental Wellbeing Rehabilitation for Acute Stress-induced Takotsubo Cardiomyopathy: The PLEASE Study
A study testing Physical Exercise Program and Cognitive Behavioural Therapy in people with Takotsubo Cardiomyopathy, run by University of Aberdeen at 1 site in United Kingdom.
Trial summary
Takotsubo cardiomyopathy presents like a heart attack and is typically triggered by intense emotional or physical stress. Recovery of this condition varies and many patients continue to suffer from symptoms such as fatigue and breathlessness for a protracted period after their event. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Takotsubo Cardiomyopathy
- What is being tested?
- Physical Exercise Program and Cognitive Behavioural Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2019to 1 Sep 2023
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A patient who has recently suffered an episode of takotsubo cardiomyopathy within the last three weeks
- Participant who is willing and able to give informed consent for participation in the study.
Who cannot join
- Any patient whose takotsubo cardiomyopathy was triggered by a physical illness that would preclude them for taking part in a physical exercise training program.
- Any patient who is not able or not willing to travel to the cardiovascular research facility for their study visits.
- Any patient who is not able to commit to a 12 week supervised training program.
- Inability to exercise on a cycle ergometer (i.e. use of walking aids or prosthetic limbs).
- Contraindication to magnetic resonance scanning such as an implantable cardiac device.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cardiac Research Facility
Aberdeen, Aberdeenshire, AB25 2ZN
About this study
Takotsubo cardiomyopathy presents like a heart attack and is typically triggered by intense emotional or physical stress. Recovery of this condition varies and many patients continue to suffer from symptoms such as fatigue and breathlessness for a protracted period after their event. Research conducted in our unit has found that the heart function does not recover fully as is commonly believed and that the energetic status of the heart remains impaired for an extended period of time. The purpose of our study is to establish whether following a structured exercise program or a mental wellbeing program compared to usual care for 12 weeks after an episode of Takotsubo will improve the energy status of the heart, their physical conditioning and improve the general mental wellbeing of patients.
Read the detailed description
Acute takotsubo cardiomyopathy is characterised by sudden onset left ventricular dysfunction precipitated by major stress. The researchers have shown that recovery is more protracted than previously appreciated, and is associated with persistent major morbidity and a long-term heart failure phenotype. In the absence of any effective therapeutic options, the researchers propose a mechanistic three-arm pilot feasibility trial of early rehabilitation (standardised physical exercise training or cognitive behavioural therapy) versus current standard of care in patients who suffered a very recent episode of takotsubo cardiomyopathy. The primary end-point will be the restoration of cardiac energetic status assessed by 31P-magnetic resonance spectroscopy and the secondary end-points of cortisol awakening response, global longitudinal strain by echocardiography and the 6-minute walk test. If successful, this has the potential for rapid implementation into a large randomised clinical trial.
- Conditions
- Takotsubo Cardiomyopathy
- Being tested
- Physical Exercise Program, Cognitive Behavioural Therapy
- Medical subject headings
- Takotsubo Cardiomyopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Exercise ProgramOther
A structured exercise program
Cognitive Behavioural TherapyBehavioural
A structured cognitive behavioural therapy program
| Study group | Role | What they receive |
|---|---|---|
| Physical Exercise Group | Experimental | A structured exercise program for 12 weeks Receives: Other: Physical Exercise Program |
| Cognitive Behavioural Therapy | Experimental | Cognitive Behavioural Therapy for 12 weeks Receives: Behavioral: Cognitive Behavioural Therapy |
| Standard Clinical Care | No intervention | Standard Clinical Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Energetics
Cardiac Magnetic Resonance Imaging and Magnetic Resonance Spectroscopy
Measured: Within three weeks after diagnosis
Cardiac Energetics
Cardiac Magnetic Resonance Imaging and Magnetic Resonance Spectroscopy
Measured: At completion of 12 weeks intervention
Secondary outcomes (6)
Left Ventricular Global Longitudinal Strain
Echocardiography
Measured: Within three weeks after diagnosis
Left Ventricular Global Longitudinal Strain
Echocardiography
Measured: At completion of 12 weeks intervention
Exercise Capacity
6 minute walk test and Cardiopulmonary Exercise Test
Measured: Within three weeks after diagnosis
Exercise Capacity
6 minute walk test and Cardiopulmonary Exercise Test
Measured: At completion of 12 weeks intervention
Mental status and Stress
Index of Mental Wellbeing and Cortisol Awakening Response
Measured: Within three weeks after diagnosis
Mental status and Stress
Index of Mental Wellbeing and Cortisol Awakening Response
Measured: At completion of 12 weeks intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 Mar 2019
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled study. Takotsubo patients will be randomised into one of the following groups: Exercise Arm Cognitive Behavioural Arm Standard Clinical Care
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Collaborators
- British Heart Foundation
- Responsible party
- Sponsor
- Investigators
- Dana Dawson, MPhil, Principal investigator, University of Aberdeen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04425785
- Sponsor's protocol ID
- 2-115-18
- Acronym
- PLEASE
- Status last verified
- Dec 2023
- First submitted
- 27 May 2020
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Prasad A, Lerman A, Rihal CS. Apical ballooning syndrome (Tako-Tsubo or stress cardiomyopathy): a mimic of acute myocardial infarction. Am Heart J. 2008 Mar;155(3):408-17. doi: 10.1016/j.ahj.2007.11.008. Epub 2008 Jan 31.
PubMed 18294473Templin 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 26332547Tornvall P, Collste O, Ehrenborg E, Jarnbert-Petterson H. A Case-Control Study of Risk Markers and Mortality in Takotsubo Stress Cardiomyopathy. J Am Coll Cardiol. 2016 Apr 26;67(16):1931-6. doi: 10.1016/j.jacc.2016.02.029.
PubMed 27102508Stiermaier T, Moeller C, Oehler K, Desch S, Graf T, Eitel C, Vonthein R, Schuler G, Thiele H, Eitel I. Long-term excess mortality in takotsubo cardiomyopathy: predictors, causes and clinical consequences. Eur J Heart Fail. 2016 Jun;18(6):650-6. doi: 10.1002/ejhf.494. Epub 2016 Mar 14.
PubMed 26990821Scally C, Rudd A, Mezincescu A, Wilson H, Srivanasan J, Horgan G, Broadhurst P, Newby DE, Henning A, Dawson DK. Persistent Long-Term Structural, Functional, and Metabolic Changes After Stress-Induced (Takotsubo) Cardiomyopathy. Circulation. 2018 Mar 6;137(10):1039-1048. doi: 10.1161/CIRCULATIONAHA.117.031841. Epub 2017 Nov 11.
PubMed 29128863Isogai T, Matsui H, Tanaka H, Fushimi K, Yasunaga H. Early beta-blocker use and in-hospital mortality in patients with Takotsubo cardiomyopathy. Heart. 2016 Jul 1;102(13):1029-35. doi: 10.1136/heartjnl-2015-308712. Epub 2016 Feb 15.
PubMed 26879240Singh K, Carson K, Usmani Z, Sawhney G, Shah R, Horowitz J. Systematic review and meta-analysis of incidence and correlates of recurrence of takotsubo cardiomyopathy. Int J Cardiol. 2014 Jul 1;174(3):696-701. doi: 10.1016/j.ijcard.2014.04.221. Epub 2014 Apr 26.
PubMed 24809923Kitzman DW, Brubaker PH, Herrington DM, Morgan TM, Stewart KP, Hundley WG, Abdelhamed A, Haykowsky MJ. Effect of endurance exercise training on endothelial function and arterial stiffness in older patients with heart failure and preserved ejection fraction: a randomized, controlled, single-blind trial. J Am Coll Cardiol. 2013 Aug 13;62(7):584-92. doi: 10.1016/j.jacc.2013.04.033. Epub 2013 May 9.
PubMed 23665370Coats AJ, Adamopoulos S, Radaelli A, McCance A, Meyer TE, Bernardi L, Solda PL, Davey P, Ormerod O, Forfar C, et al. Controlled trial of physical training in chronic heart failure. Exercise performance, hemodynamics, ventilation, and autonomic function. Circulation. 1992 Jun;85(6):2119-31. doi: 10.1161/01.cir.85.6.2119.
PubMed 1591831O'Connor CM, Whellan DJ, Lee KL, Keteyian SJ, Cooper LS, Ellis SJ, Leifer ES, Kraus WE, Kitzman DW, Blumenthal JA, Rendall DS, Miller NH, Fleg JL, Schulman KA, McKelvie RS, Zannad F, Pina IL; HF-ACTION Investigators. Efficacy and safety of exercise training in patients with chronic heart failure: HF-ACTION randomized controlled trial. JAMA. 2009 Apr 8;301(14):1439-50. doi: 10.1001/jama.2009.454.
PubMed 19351941Hegde SM, Claggett B, Shah AM, Lewis EF, Anand I, Shah SJ, Sweitzer NK, Fang JC, Pitt B, Pfeffer MA, Solomon SD. Physical Activity and Prognosis in the TOPCAT Trial (Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist). Circulation. 2017 Sep 12;136(11):982-992. doi: 10.1161/CIRCULATIONAHA.117.028002. Epub 2017 Jun 21.
PubMed 28637881Pandey A, Garg S, Khunger M, Darden D, Ayers C, Kumbhani DJ, Mayo HG, de Lemos JA, Berry JD. Dose-Response Relationship Between Physical Activity and Risk of Heart Failure: A Meta-Analysis. Circulation. 2015 Nov 10;132(19):1786-94. doi: 10.1161/CIRCULATIONAHA.115.015853. Epub 2015 Oct 5.
PubMed 26438781Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
PubMed 6880820Smolderen KG, Buchanan DM, Gosch K, Whooley M, Chan PS, Vaccarino V, Parashar S, Shah AJ, Ho PM, Spertus JA. Depression Treatment and 1-Year Mortality After Acute Myocardial Infarction: Insights From the TRIUMPH Registry (Translational Research Investigating Underlying Disparities in Acute Myocardial Infarction Patients' Health Status). Circulation. 2017 May 2;135(18):1681-1689. doi: 10.1161/CIRCULATIONAHA.116.025140. Epub 2017 Feb 16.
PubMed 28209727Rozanski A, Blumenthal JA, Davidson KW, Saab PG, Kubzansky L. The epidemiology, pathophysiology, and management of psychosocial risk factors in cardiac practice: the emerging field of behavioral cardiology. J Am Coll Cardiol. 2005 Mar 1;45(5):637-51. doi: 10.1016/j.jacc.2004.12.005.
PubMed 15734605
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Exercise and Mental Wellbeing Rehabilitation for Acute Stress-induced Takotsubo Cardiomyopathy: The PLEASE Study
- ClinicalTrials.gov ID
- NCT04425785
- Acronym / sponsor ID
- PLEASE / 2-115-18
- Conditions
- Takotsubo Cardiomyopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Collaborators
- British Heart Foundation
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 11 Jun 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.
Takotsubo cardiomyopathy presents like a heart attack and is typically triggered by intense emotional or physical stress. Recovery of this condition varies and many patients continue to suffer from symptoms such as fatigue and breathlessness for a protracted period after their event. Research conducted in our unit has found that the heart function does not recover fully as is commonly believed and that the energetic status of the heart remains impaired for an extended period of time. The purpose of our study is to establish whether following a structured exercise program or a mental wellbeing program compared to usual care for 12 weeks after an episode of Takotsubo will improve the energy status of the heart, their physical conditioning and improve the general mental wellbeing of patients.
Detailed description
Acute takotsubo cardiomyopathy is characterised by sudden onset left ventricular dysfunction precipitated by major stress. The researchers have shown that recovery is more protracted than previously appreciated, and is associated with persistent major morbidity and a long-term heart failure phenotype. In the absence of any effective therapeutic options, the researchers propose a mechanistic three-arm pilot feasibility trial of early rehabilitation (standardised physical exercise training or cognitive behavioural therapy) versus current standard of care in patients who suffered a very recent episode of takotsubo cardiomyopathy. The primary end-point will be the restoration of cardiac energetic status assessed by 31P-magnetic resonance spectroscopy and the secondary end-points of cortisol awakening response, global longitudinal strain by echocardiography and the 6-minute walk test. If successful, this has the potential for rapid implementation into a large randomised clinical trial.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomised controlled study. Takotsubo patients will be randomised into one of the following groups: Exercise Arm Cognitive Behavioural Arm Standard Clinical Care
| Arm | Type | Receives |
|---|---|---|
| Physical Exercise Group | Experimental | Other: Physical Exercise ProgramA structured exercise program for 12 weeks |
| Cognitive Behavioural Therapy | Experimental | Behavioral: Cognitive Behavioural TherapyCognitive Behavioural Therapy for 12 weeks |
| Standard Clinical Care | No intervention | –Standard Clinical Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A patient who has recently suffered an episode of takotsubo cardiomyopathy within the last three weeks
- Participant who is willing and able to give informed consent for participation in the study.
Key exclusion criteria (6 listed)
- Any patient whose takotsubo cardiomyopathy was triggered by a physical illness that would preclude them for taking part in a physical exercise training program.
- Any patient who is not able or not willing to travel to the cardiovascular research facility for their study visits.
- Any patient who is not able to commit to a 12 week supervised training program.
- Inability to exercise on a cycle ergometer (i.e. use of walking aids or prosthetic limbs).
- Contraindication to magnetic resonance scanning such as an implantable cardiac device.
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 |
|---|---|---|
| Physical Exercise ProgramA structured exercise program | Other | Physical Exercise Group |
| Cognitive Behavioural TherapyA structured cognitive behavioural therapy program | Behavioural | Cognitive Behavioural Therapy |
Primary outcome
Cardiac Energetics
Time frame: Within three weeks after diagnosis
Cardiac Magnetic Resonance Imaging and Magnetic Resonance Spectroscopy
Cardiac Energetics
Time frame: At completion of 12 weeks intervention
Cardiac Magnetic Resonance Imaging and Magnetic Resonance Spectroscopy
6 secondary outcomes
Left Ventricular Global Longitudinal Strain
Time frame: Within three weeks after diagnosis
Left Ventricular Global Longitudinal Strain
Time frame: At completion of 12 weeks intervention
Exercise Capacity
Time frame: Within three weeks after diagnosis
Exercise Capacity
Time frame: At completion of 12 weeks intervention
Mental status and Stress
Time frame: Within three weeks after diagnosis
Mental status and Stress
Time frame: At completion of 12 weeks intervention
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 8 Dec 2023.
- Background: PubMed 18294473Prasad A, Lerman A, Rihal CS. Apical ballooning syndrome (Tako-Tsubo or stress cardiomyopathy): a mimic of acute myocardial infarction. Am Heart J. 2008 Mar;155(3):408-17. doi: 10.1016/j.ahj.2007.11.008. Epub 2008 Jan 31.
- 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.
- Background: PubMed 27102508Tornvall P, Collste O, Ehrenborg E, Jarnbert-Petterson H. A Case-Control Study of Risk Markers and Mortality in Takotsubo Stress Cardiomyopathy. J Am Coll Cardiol. 2016 Apr 26;67(16):1931-6. doi: 10.1016/j.jacc.2016.02.029.
- Background: PubMed 26990821Stiermaier T, Moeller C, Oehler K, Desch S, Graf T, Eitel C, Vonthein R, Schuler G, Thiele H, Eitel I. Long-term excess mortality in takotsubo cardiomyopathy: predictors, causes and clinical consequences. Eur J Heart Fail. 2016 Jun;18(6):650-6. doi: 10.1002/ejhf.494. Epub 2016 Mar 14.
- Background: PubMed 29128863Scally C, Rudd A, Mezincescu A, Wilson H, Srivanasan J, Horgan G, Broadhurst P, Newby DE, Henning A, Dawson DK. Persistent Long-Term Structural, Functional, and Metabolic Changes After Stress-Induced (Takotsubo) Cardiomyopathy. Circulation. 2018 Mar 6;137(10):1039-1048. doi: 10.1161/CIRCULATIONAHA.117.031841. Epub 2017 Nov 11.
- Background: PubMed 26879240Isogai T, Matsui H, Tanaka H, Fushimi K, Yasunaga H. Early beta-blocker use and in-hospital mortality in patients with Takotsubo cardiomyopathy. Heart. 2016 Jul 1;102(13):1029-35. doi: 10.1136/heartjnl-2015-308712. Epub 2016 Feb 15.
- Background: PubMed 24809923Singh K, Carson K, Usmani Z, Sawhney G, Shah R, Horowitz J. Systematic review and meta-analysis of incidence and correlates of recurrence of takotsubo cardiomyopathy. Int J Cardiol. 2014 Jul 1;174(3):696-701. doi: 10.1016/j.ijcard.2014.04.221. Epub 2014 Apr 26.
- Background: PubMed 23665370Kitzman DW, Brubaker PH, Herrington DM, Morgan TM, Stewart KP, Hundley WG, Abdelhamed A, Haykowsky MJ. Effect of endurance exercise training on endothelial function and arterial stiffness in older patients with heart failure and preserved ejection fraction: a randomized, controlled, single-blind trial. J Am Coll Cardiol. 2013 Aug 13;62(7):584-92. doi: 10.1016/j.jacc.2013.04.033. Epub 2013 May 9.
- Background: PubMed 1591831Coats AJ, Adamopoulos S, Radaelli A, McCance A, Meyer TE, Bernardi L, Solda PL, Davey P, Ormerod O, Forfar C, et al. Controlled trial of physical training in chronic heart failure. Exercise performance, hemodynamics, ventilation, and autonomic function. Circulation. 1992 Jun;85(6):2119-31. doi: 10.1161/01.cir.85.6.2119.
- Background: PubMed 19351941O'Connor CM, Whellan DJ, Lee KL, Keteyian SJ, Cooper LS, Ellis SJ, Leifer ES, Kraus WE, Kitzman DW, Blumenthal JA, Rendall DS, Miller NH, Fleg JL, Schulman KA, McKelvie RS, Zannad F, Pina IL; HF-ACTION Investigators. Efficacy and safety of exercise training in patients with chronic heart failure: HF-ACTION randomized controlled trial. JAMA. 2009 Apr 8;301(14):1439-50. doi: 10.1001/jama.2009.454.
- Background: PubMed 28637881Hegde SM, Claggett B, Shah AM, Lewis EF, Anand I, Shah SJ, Sweitzer NK, Fang JC, Pitt B, Pfeffer MA, Solomon SD. Physical Activity and Prognosis in the TOPCAT Trial (Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist). Circulation. 2017 Sep 12;136(11):982-992. doi: 10.1161/CIRCULATIONAHA.117.028002. Epub 2017 Jun 21.
- Background: PubMed 26438781Pandey A, Garg S, Khunger M, Darden D, Ayers C, Kumbhani DJ, Mayo HG, de Lemos JA, Berry JD. Dose-Response Relationship Between Physical Activity and Risk of Heart Failure: A Meta-Analysis. Circulation. 2015 Nov 10;132(19):1786-94. doi: 10.1161/CIRCULATIONAHA.115.015853. Epub 2015 Oct 5.
- Individual participant dataSharing planned: No
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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.
Dana Dawson, MPhil principal investigator
University of Aberdeen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Exercise Program and Cognitive Behavioural Therapy in people with Takotsubo Cardiomyopathy, run by University of Aberdeen at 1 site in United Kingdom.
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 2 inclusion and 6 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 8 Dec 2023. 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 United Kingdom. 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?
Cardiac Energetics (time frame: Within three weeks after diagnosis). The study lists 2 primary outcomes in all. 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 NCT04425785, which also lists 35 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 8 Dec 2023.