NCT03317249

Pregnancy Related Inappropriate Sinus Tachycardia

Pregnancy Related Inappropriate Sinus Tachycardia Syndrome Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Cambridge University Hospitals NHS Foundation Trust · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

A feasibility study into the exploration of possible mechanisms underlying inappropriate sinus tachycardia (IST) syndrome in pregnancy.

Detailed description

This is a non-interventional, physiological study which will explore the feasibility of examining autonomic function and related haemodynamic variables in pregnant women with and without inappropriate sinus tachycardia, with the aim of providing scope for future research. Sinus tachycardia (normal heart rhythm but fast heart rate) is common and usually related to an obvious cause (e.g. exercise such a running or cycling) and doesn't cause any untoward symptoms. In rare cases however, sinus tachycardia can occur without an obvious cause (i.e. it is inappropriate to the situation) and can cause distressing symptoms such as palpitations, dizziness and breathlessness at rest or with minimal exertion. This syndrome of inappropriate sinus tachycardia is poorly understood and can be difficult to manage; especially when the affected individual is pregnant. In order to understand the condition better and improve care pathways we aim to measure various features of the cardiovascular system in pregnant women with and without IST.

Conditions

• Inappropriate Sinus Tachycardia
• Pregnancy Related

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	ECG	12-lead electrocardiogram
DIAGNOSTIC_TEST	heart rate monitor	24-hour heart rate monitor used to calculate mean heart rate and heart rate variability
DIAGNOSTIC_TEST	Autonomic Nervous System (ANS) Activity	Heart Rate Variability (HRV) and Baroreflex sensitivity (BRS): Resting and exercise HRV and BRS calculated from ECG, Dundee Step test and blood pressure measurements.
DIAGNOSTIC_TEST	Haemodynamic variables	Cardiac output (CO), stroke volume (SV) and systematic vascular resistance (SVR) will be assessed and calculated using a non-invasive, inert gas re-breathing technique whereby expired gases will be sampled and analysed alongside and blood pressure measurements.
OTHER	Echocardiogram	optional (for non-IST participants only)

Timeline

• Start date: 2017-10-06
• Primary completion: 2020-10-06
• Completion: 2020-10-06
• First posted: 2017-10-23
• Last updated: 2019-01-22

Locations

1 site across 1 country: United Kingdom