Takotsubo CardiomyopathyPhase 1/2SAFTNCT05768542
Sympathetic and Vascular Function in Takotsubo Syndrome
A Phase 1/2 study testing Metoprolol Injection and Saline in people with Takotsubo Cardiomyopathy, run by Danderyd Hospital.
Trial summary
The primary objective of this prospective, observational study is to compare muscle sympathetic nerve activity at rest and during stress between female patients with Takotsubo syndrome and healthy, matched volunteers. Read more about this study
- Who is it for?
- Ages 40 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Takotsubo Cardiomyopathy
- What is being tested?
- Metoprolol Injection and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- 12 Apr 2016to 23 Jan 2023
- Phase
- Phase 1/2
- 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 40 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For patients:
- Diagnosis of Takotsubo cardiomyopathy
- For Controls:
- Matching age with Takotsubo patients
- Signed informed consent
Who cannot join
- Coronary anathomy precluding intracoronary investigations
- Severe obstructive pulmonary disease
- Kidney failure with estimated glomerular filtration rate < 30 ml/min/m2
- Active malignancy
- Pericarditis
About this study
Official title: Vacular Structure, Function and Sympathetic Activity in Takotsubo Syndrome
The primary objective of this prospective, observational study is to compare muscle sympathetic nerve activity at rest and during stress between female patients with Takotsubo syndrome and healthy, matched volunteers.
- Do Takotsubo patients have an increased sympathetic nerve activity compared to controls?
- Do Takotsubo patients have an exaggerated sympathetic nerve activity response to stress?
- Does the sympathetic nerve activity response to stress in Takotsubo change after receiving the beta blocking agent metoprolol?
Participants will be examined with muscle sympathetic nerve activity recording in the peroneal nerve at rest and during cold pressor test. After intravenous injection with beta blocking agent (metoprolol) or placebo (saline) in a 1:1 randomized fashion, muscle sympathetic nerve recording at rest and during stress will be repeated.
Read the detailed description
Female Takotsubo patients included in the SAFT (sympathetic and vascular function in Takotsubo syndrome) study will be invited to undergo microneurography recording of muscle sympathetic nerve activity (MSNA) at rest and during stress one week to two month after study inclusion. Responses to stress with and without the commonly used betablocking agent metoprolol will be compares.
Microneurography will be performed in the morning after a light caffeine-free breakfast with the subject supine and awake. Any medication with a beta blocking agent will be discontinued 24 hours prior to examination. MSNA will be recorded by inserting a tungsten electrode into the sympathetic nerve fibres of the peroneal nerve, with simultaneous blood pressure and heart rate monitoring.
MSNA recording will then continue during stress induced by placing one of the subjects hand in ice-cold water for 90 seconds (cold pressor test).
After intravenous injection with beta blocking agent (metoprolol) or placebo (saline) in a 1:1 randomized fashion, MSNA recording at rest and during stress will be repeated.
Age- and gender-matched healthy volunteers will be recruited as controls and examined similarly with microneurography at rest and during stress.
MSNA recordings will be amplified, computerized and saved for further analyses. MSNA will be quantified as burst incidence (burst per 100 heartbeats), burst frequence (bursts per minute) and relative median burst amplitude (%). MSNA activity will be compared between Takotsubo patients and controls and before and after betablockade in Takotsubo patients.
- Conditions
- Takotsubo Cardiomyopathy
- Being tested
- Metoprolol Injection, Saline
- Medical subject headings
- Takotsubo Cardiomyopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metoprolol InjectionDrug
If heart rate below 60, give 5 mg IV. If heart rate above 60, give 5 mg IV and repeat until heart rate below 65 or 20 mg given in total or systolic blood pressure below 110 mmHg.
SalineDrug
5 ml given IV
| Study group | Role | What they receive |
|---|---|---|
| Takotsubo Control | Active comparator | Patients with Takotsubo receiving betablockade Receives: Drug: Metoprolol Injection |
| Takotsubo Intervention | Placebo comparator | Patients with Takotsubo receiving placebo Receives: Drug: Saline |
| Control | No intervention | Control subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting MSNA
Muscle sympathetic nerve activity during rest
Measured: During 5 minutes rest
MSNA increase during CPT
Muscle sympathetic nerve activity increase during cold pressor test
Measured: During the last 60 seconds of the CPT
Secondary outcomes (2)
MSNA increase during CPT after intervention
Muscle sympathetic nerve activity increase during cold pressor test after betablockade
Measured: During the last 60 seconds of the CPT
Hemodynamic changes during CPT
Change in blood pressure
Measured: During the last 60 seconds of the CPT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start12 Apr 2016
- Primary completion23 Mar 2022
- Study completion23 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Control group for primary outcome
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danderyd Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonas 9, MD, PhD, Principal investigator, Danderyd University Hospital and karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05768542
- Sponsor's protocol ID
- SAFT
- Acronym
- SAFT
- Status last verified
- Oct 2022
- First submitted
- 26 Jan 2023
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Needs approval according to GDPR but PI positive to requests
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vacular Structure, Function and Sympathetic Activity in Takotsubo Syndrome
- ClinicalTrials.gov ID
- NCT05768542
- Acronym / sponsor ID
- SAFT / SAFT
- Conditions
- Takotsubo Cardiomyopathy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Danderyd HospitalUniversity, hospital or other
- Study start
- 12 Apr 2016 (actual)
- Primary completion
- 23 Mar 2022 (actual)
- Study completion
- 23 Jan 2023 (actual)
- First posted
- 14 Mar 2023 (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 primary objective of this prospective, observational study is to compare muscle sympathetic nerve activity at rest and during stress between female patients with Takotsubo syndrome and healthy, matched volunteers.
- Do Takotsubo patients have an increased sympathetic nerve activity compared to controls?
- Do Takotsubo patients have an exaggerated sympathetic nerve activity response to stress?
- Does the sympathetic nerve activity response to stress in Takotsubo change after receiving the beta blocking agent metoprolol?
Participants will be examined with muscle sympathetic nerve activity recording in the peroneal nerve at rest and during cold pressor test. After intravenous injection with beta blocking agent (metoprolol) or placebo (saline) in a 1:1 randomized fashion, muscle sympathetic nerve recording at rest and during stress will be repeated.
Detailed description
Female Takotsubo patients included in the SAFT (sympathetic and vascular function in Takotsubo syndrome) study will be invited to undergo microneurography recording of muscle sympathetic nerve activity (MSNA) at rest and during stress one week to two month after study inclusion. Responses to stress with and without the commonly used betablocking agent metoprolol will be compares.
Microneurography will be performed in the morning after a light caffeine-free breakfast with the subject supine and awake. Any medication with a beta blocking agent will be discontinued 24 hours prior to examination. MSNA will be recorded by inserting a tungsten electrode into the sympathetic nerve fibres of the peroneal nerve, with simultaneous blood pressure and heart rate monitoring.
MSNA recording will then continue during stress induced by placing one of the subjects hand in ice-cold water for 90 seconds (cold pressor test).
After intravenous injection with beta blocking agent (metoprolol) or placebo (saline) in a 1:1 randomized fashion, MSNA recording at rest and during stress will be repeated.
Age- and gender-matched healthy volunteers will be recruited as controls and examined similarly with microneurography at rest and during stress.
MSNA recordings will be amplified, computerized and saved for further analyses. MSNA will be quantified as burst incidence (burst per 100 heartbeats), burst frequence (bursts per minute) and relative median burst amplitude (%). MSNA activity will be compared between Takotsubo patients and controls and before and after betablockade in Takotsubo patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Control group for primary outcome
| Arm | Type | Receives |
|---|---|---|
| Takotsubo Control | Active comparator | Drug: Metoprolol InjectionPatients with Takotsubo receiving betablockade |
| Takotsubo Intervention | Placebo comparator | Drug: SalinePatients with Takotsubo receiving placebo |
| Control | No intervention | –Control subjects |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of Takotsubo cardiomyopathy
- Matching age with Takotsubo patients
- Signed informed consent
Key exclusion criteria (5 listed)
- Coronary anathomy precluding intracoronary investigations
- Severe obstructive pulmonary disease
- Kidney failure with estimated glomerular filtration rate < 30 ml/min/m2
- Active malignancy
- Pericarditis
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 |
|---|---|---|
| Metoprolol InjectionIf heart rate below 60, give 5 mg IV. If heart rate above 60, give 5 mg IV and repeat until heart rate below 65 or 20 mg given in total or systolic blood pressure below 110 mmHg. | Drug | Takotsubo Control |
| Saline5 ml given IV | Drug | Takotsubo Intervention |
Primary outcome
Resting MSNA
Time frame: During 5 minutes rest
Muscle sympathetic nerve activity during rest
MSNA increase during CPT
Time frame: During the last 60 seconds of the CPT
Muscle sympathetic nerve activity increase during cold pressor test
2 secondary outcomes
MSNA increase during CPT after intervention
Time frame: During the last 60 seconds of the CPT
Hemodynamic changes during CPT
Time frame: During the last 60 seconds of the CPT
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 14 Mar 2023.
- Individual participant dataSharing planned: No. Needs approval according to GDPR but PI positive to requests
Related trials for Takotsubo Cardiomyopathy
Active, not recruitingObservational study
The Role of CD34+ Stem Cells in the Pathogenesis of Takotsubo Syndrome
Tako Tsubo Cardiomyopathy, Microvascular Dysfunction
Recruiting
Manganese-enhanced Magnetic Resonance Imaging in Takotsubo Cardiomyopathy
Takotsubo Cardiomyopathy
RecruitingObservational study
Cardiac Assessment and Takotsubo-stunning Among COPD-exacerbations In-Hospital
Chronic Obstructive Pulmonary Disease, Takotsubo Cardiomyopathy
RecruitingObservational study
Establishing the Incidence of Tako-tsubo Cardiomyopathy in Scotland
Takotsubo Cardiomyopathy, Myocardial Infarction
RecruitingObservational study
Cardiomyopathies and Heart Muscle Diseases: Cardiac Imaging in the Evaluation of Myocardial Fibrosis Transition
Heart Failure With Preserved Ejection Fraction, Hypertrophic Cardiomyopathy
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.
Jonas 9, MD, PhD principal investigator
Danderyd University Hospital and karolinska Institutet
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Metoprolol Injection and Saline in people with Takotsubo Cardiomyopathy, run by Danderyd Hospital.
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 5 inclusion and 5 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 14 Mar 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Resting MSNA (time frame: During 5 minutes rest). 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?
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 14 Mar 2023.