Pregnancy Related Inappropriate Sinus Tachycardia

Pregnancy Related Clinical Trial

— PRIST  

Official title:

Pregnancy Related Inappropriate Sinus Tachycardia Syndrome Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03317249
• Other study ID #: PRIST
• Status: Recruiting
• Start date: October 6, 2017
• Est. completion date: October 6, 2020

Study information

• Verified date: January 2019
• Source: Cambridge University Hospitals NHS Foundation Trust
• Contact: Mark Belham
• Phone: 01223 349154
• Email: mark.belham[@]addenbrookes.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 6, 2020
• Est. primary completion date: October 6, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Aged 18-45 years of age

• Able to give written informed consent and willing to participate

• The participant falls into one of the below categories:

i. Pregnant women with IST ii. Pregnant women without IST

Exclusion Criteria:

• Obesity (BMI > 29.9)

• Current or recent (within last 3 months) smoker

• Known medical condition likely to affect HRV (other than IST in relevant groups)

• Previous history of hypertensive disorders in pregnancy

• Lack of written informed consent

Related Conditions & MeSH terms

• Inappropriate Sinus Tachycardia
• Pregnancy Related
• Tachycardia
• Tachycardia, Sinus

Intervention

Diagnostic Test:
• ECG
12-lead electrocardiogram
• heart rate monitor
24-hour heart rate monitor used to calculate mean heart rate and heart rate variability
• 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.
• 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)

Locations

Country	Name	City	State
United Kingdom	Addenbrookes Hospital	Cambridge

Sponsors (1)

Lead Sponsor	Collaborator
Cambridge University Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of examining autonomic function and related haemodynamic variables in pregnant women with and without inappropriate sinus tachycardia	Number of women in each group who agree to participate in the study	Up to 3 years
Primary	Assessment of autonomic function and related haemodynamic variables in pregnant women with and without inappropriate sinus tachycardia	Heart rate variability (HRV) at rest using time and frequency domain (e.g. SDNN ms and LF and HF), combined to give absolute power in ms².	Up to 3 years
Primary	Assessment of autonomic function and related haemodynamic variables in pregnant women with and without inappropriate sinus tachycardia	Baroreflex sensitivity (BRS) at rest calculated from the change in systolic pressure and change in R-R interval to give change in pressure per change in RR interval, measured in milliseconds (mmHg/ms)	Up to 3 years
Secondary	Assessment of ANS function in pregnant women with and without IST, at rest and during mild exercise	Stroke volume in ml	Up to 3 years
Secondary	Assessment of ANS function in pregnant women with and without IST, at rest and during mild exercise	Heart Rate Variability during mild exercise (3 minute step test) using time and frequency domain (e.g. SDNN ms and LF and HF), combined to give absolute power in ms².	Up to 3 years
Secondary	Assessment of ANS function in pregnant women with and without IST, at rest and during mild exercise	Cardiac Output in litres/minute	Up to 3 years
Secondary	Assessment of ANS function in pregnant women with and without IST, at rest and during mild exercise	Blood Pressure in mm/Hg	Up to 3 years