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Pregnancy Related Inappropriate Sinus Tachycardia

Pregnancy Related Inappropriate Sinus Tachycardia Syndrome Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03317249
Acronym
PRIST
Enrollment
200
Registered
2017-10-23
Start date
2017-10-06
Completion date
2020-10-06
Last updated
2019-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inappropriate Sinus Tachycardia, Pregnancy Related

Keywords

Inappropriate Sinus Tachycardia, Pregnancy Related, IST

Brief 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.

Interventions

DIAGNOSTIC_TESTECG

12-lead electrocardiogram

DIAGNOSTIC_TESTheart rate monitor

24-hour heart rate monitor used to calculate mean heart rate and heart rate variability

DIAGNOSTIC_TESTAutonomic 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_TESTHaemodynamic 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.

OTHEREchocardiogram

optional (for non-IST participants only)

Sponsors

Cambridge University Hospitals NHS Foundation Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of examining autonomic function and related haemodynamic variables in pregnant women with and without inappropriate sinus tachycardiaUp to 3 yearsNumber of women in each group who agree to participate in the study
Assessment of autonomic function and related haemodynamic variables in pregnant women with and without inappropriate sinus tachycardiaUp to 3 yearsHeart 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.

Secondary

MeasureTime frameDescription
Assessment of ANS function in pregnant women with and without IST, at rest and during mild exerciseUp to 3 yearsStroke volume in ml

Countries

United Kingdom

Contacts

Primary ContactMark Belham
mark.belham@addenbrookes.nhs.uk01223 349154
Backup ContactKatherine Stobbart
katherine.stobbart@addenbrookes.nhs.uk01223 596377

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026