Sympathetic and Vascular Function in Takotsubo Syndrome

NCT05768542 | Completed Phase 1

• 1 other identifier: SAFT
• Study Type: interventional
• Target: 31
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Takotsubo Cardiomyopathy

Outcome Measures

Primary Outcomes (2)

• Resting MSNA

  Muscle sympathetic nerve activity during rest

  During 5 minutes rest

• MSNA increase during CPT

  Muscle sympathetic nerve activity increase during cold pressor test

  During the last 60 seconds of the CPT

Secondary Outcomes (2)

• MSNA increase during CPT after intervention

  During the last 60 seconds of the CPT

• Hemodynamic changes during CPT

  During the last 60 seconds of the CPT

Study Arms (3)

Takotsubo Control

ACTIVE COMPARATOR

Patients with Takotsubo receiving betablockade

Drug: Metoprolol Injection

Takotsubo Intervention

PLACEBO COMPARATOR

Patients with Takotsubo receiving placebo

Drug: Saline

Control

NO INTERVENTION

Control subjects

Interventions

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.

Takotsubo Control

Saline DRUG

5 ml given IV

Takotsubo Intervention

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Danderyd Hospital: lead

MeSH Terms

Conditions

Takotsubo Cardiomyopathy

Interventions

Metoprolol; Sodium Chloride

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction, Left; Ventricular Dysfunction

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Jonas 9, MD, PhD

  Danderyd University Hospital and karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Intervention single blinded to participant. Intervention blinded to person analyzing the MSNA.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Control group for primary outcome

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: March 14, 2023
• Study Start: April 12, 2016
• Primary Completion: March 23, 2022
• Study Completion: January 23, 2023
• Last Updated: March 14, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share