NCT05768542: SAFT

Sympathetic and Vascular Function in Takotsubo Syndrome

Completed Phase 1, PHASE2 Last updated 14 March 2023

What this trial tests

Phase 1, PHASE2 trial testing Metoprolol Injection in Takotsubo Cardiomyopathy in 31 participants. Completed in 23 January 2023.

Timeline

12 April 2016

Primary endpoint
23 March 2022

23 January 2023

Quick facts

Lead sponsor	Danderyd Hospital
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	basic science
Enrollment	31
Start date	12 April 2016
Primary completion	23 March 2022
Estimated completion	23 January 2023

Drugs / interventions tested

• Metoprolol Injection
• Saline

Conditions studied

• Takotsubo Cardiomyopathy — all drugs for Takotsubo Cardiomyopathy →

Sponsor

Danderyd Hospital

Who can join

Adults 40 to 80, female only, with Takotsubo Cardiomyopathy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Takotsubo is an acute myocardial ischaemic syndrome.
   Sykes R, Ang DTY, Berry C. · · 2025 · cited 3× · PMID 39932154 · DOI 10.1093/eurheartj/ehaf020
2. Sympathetic nerve activity and response to physiological stress in Takotsubo syndrome.
   Ekenbäck C, Persson J, Tornvall P, Forsberg L, et al · · 2025 · cited 3× · PMID 39546154 · DOI 10.1007/s10286-024-01082-9
3. The Role of Inflammation in Takotsubo Syndrome: From Pathogenic Pathways To Imaging Insights and Therapeutic Perspectives.
   Madaudo C, Kurdi H, Ielapi J, Margineanu C, et al · · 2026 · PMID 41634223 · DOI 10.1007/s11886-025-02342-4