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Completed

NCT Number: NCT05768542

Sympathetic and Vascular Function 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.

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Key information

Age range

40 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metoprolol Injection

Drug

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.

Saline

Drug

5 ml given IV

Primary outcomes

  1. Resting MSNA

    Time frame: During 5 minutes rest

    Muscle sympathetic nerve activity during rest

  2. MSNA increase during CPT

    Time frame: During the last 60 seconds of the CPT

    Muscle sympathetic nerve activity increase during cold pressor test

Secondary outcomes

  1. MSNA increase during CPT after intervention

    Time frame: During the last 60 seconds of the CPT

    Muscle sympathetic nerve activity increase during cold pressor test after betablockade

  2. Hemodynamic changes during CPT

    Time frame: During the last 60 seconds of the CPT

    Change in blood pressure

Sponsors and collaborators

Lead sponsor

Danderyd Hospital

Other

Registry information

Official study title

Vacular Structure, Function and Sympathetic Activity in Takotsubo Syndrome

Acronym: SAFT

Important dates

Study start
2016
Primary completion
2022
Study completion
2023
First posted
Mar 14, 2023
Registry last updated
Mar 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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