SAFT: Sympathetic and Vascular Function in Takotsubo Syndrome

• Sponsor: Danderyd Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05768542
• Collaborator: (none)
• Enrollment: 31
• Arms: 3
• Actual Duration (Months): 81.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Takotsubo Cardiomyopathy	Drug: Metoprolol Injection; Drug: Saline	Phase 1/Phase 2

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

• Study Type: Interventional
• Actual Enrollment: 31 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Control group for primary outcomeControl group for primary outcome
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: Intervention single blinded to participant. Intervention blinded to person analyzing the MSNA.
• Primary Purpose: Basic Science
• Official Title: Vacular Structure, Function and Sympathetic Activity in Takotsubo Syndrome
• Actual Study Start Date: Apr 12, 2016
• Actual Primary Completion Date: Mar 23, 2022
• Actual Study Completion Date: Jan 23, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Takotsubo Control Patients with Takotsubo receiving betablockade	Drug: Metoprolol Injection; 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.
Placebo Comparator: Takotsubo Intervention Patients with Takotsubo receiving placebo	Drug: Saline; 5 ml given IV
No Intervention: Control Control subjects

Outcome Measures

Primary Outcome Measures

1. Resting MSNA [During 5 minutes rest]

   Muscle sympathetic nerve activity during rest

2. MSNA increase during CPT [During the last 60 seconds of the CPT]

   Muscle sympathetic nerve activity increase during cold pressor test

Secondary Outcome Measures

1. MSNA increase during CPT after intervention [During the last 60 seconds of the CPT]

   Muscle sympathetic nerve activity increase during cold pressor test after betablockade

2. Hemodynamic changes during CPT [During the last 60 seconds of the CPT]

   Change in blood pressure

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 80 Years
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Danderyd Hospital

Investigators

• Principal Investigator: Jonas 9, MD, PhD, Danderyd University Hospital and karolinska Institutet

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Danderyd Hospital
• ClinicalTrials.gov Identifier: NCT05768542
• Other Study ID Numbers: SAFT
• First Posted: Mar 14, 2023
• Last Update Posted: Mar 14, 2023
• Last Verified: Oct 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Cardiomyopathies; Takotsubo Cardiomyopathy; Metoprolol

Study Results

No Results Posted as of Mar 14, 2023