Tako-Tsubo Cardiomyopathy and Cardiac Syndrome X: New Insights Into the Pathophysiology

Takotsubo Cardiomyopathy Clinical Trial

— ENDAUT  

Official title:

Tako-Tsubo Cardiomyopathy and Cardiac Syndrome X: New Insights Into the Pathophysiology of Two Orphan Cardiac Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02307214
• Other study ID #: CE 2688
• Status: Completed
• Phase: N/A
• First received: November 26, 2014
• Last updated: April 25, 2016
• Start date: October 2013
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: Ospedale San Giovanni Bellinzona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Cantonal Office of Public Health
• Study type: Interventional

Clinical Trial Summary

Tako-Tsubo Cardiomyopathy (TTC) and Cardiac Syndrome X (CSX) are respectively acute and chronic cardiac conditions whose clinical presentation, mimicking the onset of acute myocardial ischemia in absence of epicardial coronary disease, has progressively gained the interest of the scientific community. However, despite significant progress, their underlying pathophysiology, which seems to evoke some similarities, still remains elusive. Endothelial dysfunction and autonomic imbalance have both been individually implied in their puzzling pathogenesis.

The investigators plan to conduct our study in a cohort of TTC patients, CSX patients and healthy volunteers with the following primary objective: to assess the response of endothelial function (through the Endopat score) to the autonomic tone activation induced by a 10-minute stress mental test. The assessment of autonomic tone during activation through the evaluation of Spontaneous BaRoreflex Sensitivity (BRS) and its correlation with endothelial function (Endopat score) will represent secondary objectives.

Our study will enroll 15 patients with TTC at least six months after the event, 15 patients with classic CSX and 15 healthy volunteers who will serve as control.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with the Mayo Clinic's criteria established diagnosis of TTC at least 6 month after the acute event

• Patients with CSX defined by the presence of anginal pain, positive exercise stress testing and negative coronary angiography.

• A comparable cohort of healthy volunteers age and sex-matched with patients

Exclusion Criteria:

• Short-term life-threatening pathology (life expectancy < 6 months)

• Physically unable to participate in the study

• Compliance not guaranteed

• Pregnancy

• Conditions that make BRS and Endopat measurements impossible

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cardiomyopathies
• Syndrome
• Syndrome X
• Takotsubo Cardiomyopathy

Intervention

Other:
• BaroReflex Sensitivity, endothelial function measurement
no other

Locations

Country	Name	City	State
Switzerland	Ospedale Regionale di Bellinzona e Valli - Ospedale San Giovanni, Bellinzona	Bellinzona	Canton Ticino

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale San Giovanni Bellinzona

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in endothelial function in response to autonomic tone (Endopat score)	Difference in endothelial function assessed by Endopat score in response to autonomic tone induced by 10-minute mental stress test between the three groups (CSX, TTC, healty volunteers)	Baseline	No
Secondary	BaroReflex Sensitivity (Sensitivity measurement by volume-clamp method (Finapress)	Changes in BaroReflex Sensitivity from baseline in three three groups (CSX, TTC, healty volunteers)	Baseline	No
Secondary	BaroReflex Sensitivity and endothelial dysfunction (	Correlation with between BaroReflex Sensitivity [volume clamp method] and EndoPAT score in the three groups (CSX, TTC, healty volunteers)	Baseline	No
Secondary	Endothelial dysfunction (Changes in Endopat score)	Changes in Endopat score from baseline in three three groups (CSX, TTC, healty volunteers)	Baseline	No