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Sympathetic and Vascular Function in Takotsubo Syndrome

Vacular Structure, Function and Sympathetic Activity in Takotsubo Syndrome

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05768542
Acronym
SAFT
Enrollment
31
Registered
2023-03-14
Start date
2016-04-12
Completion date
2023-01-23
Last updated
2023-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Takotsubo Cardiomyopathy

Brief 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. * 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.

Interventions

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.

DRUGSaline

5 ml given IV

Sponsors

Danderyd Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Intervention single blinded to participant. Intervention blinded to person analyzing the MSNA.

Intervention model description

Control group for primary outcome

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

For patients: * Diagnosis of Takotsubo cardiomyopathy For Controls: * Matching age with Takotsubo patients * Signed informed consent

Exclusion criteria

* Coronary anathomy precluding intracoronary investigations * Severe obstructive pulmonary disease * Kidney failure with estimated glomerular filtration rate \< 30 ml/min/m2 * Active malignancy * Pericarditis

Design outcomes

Primary

MeasureTime frameDescription
Resting MSNADuring 5 minutes restMuscle sympathetic nerve activity during rest
MSNA increase during CPTDuring the last 60 seconds of the CPTMuscle sympathetic nerve activity increase during cold pressor test

Secondary

MeasureTime frameDescription
MSNA increase during CPT after interventionDuring the last 60 seconds of the CPTMuscle sympathetic nerve activity increase during cold pressor test after betablockade
Hemodynamic changes during CPTDuring the last 60 seconds of the CPTChange in blood pressure

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026