Pregnancy Related Inappropriate Sinus Tachycardia (PRIST)

Pregnancy Related Inappropriate Sinus Tachycardia Syndrome Study

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

Study Overview

• Status: Unknown
• Conditions: Pregnancy Related; Inappropriate Sinus Tachycardia
• Intervention / Treatment: Diagnostic test: ECG; Diagnostic test: heart rate monitor; Diagnostic test: Autonomic Nervous System (ANS) Activity; Diagnostic test: Haemodynamic variables; Other: Echocardiogram

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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
    • Recruiting
    • Addenbrookes Hospital
    • Contact: Mark Belham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Hospital clinics (cardiology clinics and antenatal clinics)

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pregnant Healthy; Pregnant females aged between 18-45 years who do not have IST syndrome	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)
Pregnant IST; Pregnant females aged between 18-45 years who have IST syndrome	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Cambridge University Hospitals NHS Foundation Trust
• Investigators: Principal Investigator: Mark Belham, Addenbrookes Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2017
• Primary Completion (Anticipated): October 6, 2020
• Study Completion (Anticipated): October 6, 2020

Study Registration Dates

• First Submitted: October 6, 2017
• First Submitted That Met QC Criteria: October 19, 2017
• First Posted (Actual): October 23, 2017

Study Record Updates

• Last Update Posted (Actual): January 22, 2019
• Last Update Submitted That Met QC Criteria: January 18, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: IST; Inappropriate Sinus Tachycardia; Pregnancy Related
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia, Supraventricular; Tachycardia; Tachycardia, Sinus
• Other Study ID Numbers: PRIST

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No