Clinical trial NCT03317249: Pregnancy Related Inappropriate Sinus Tachycardia
Official title: Pregnancy Related Inappropriate Sinus Tachycardia Syndrome Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inappropriate Sinus Tachycardia
Pregnancy Related
Keywords: Inappropriate Sinus Tachycardia
Pregnancy Related
IST
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2017-10-23
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital clinics (cardiology clinics and antenatal clinics)

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of examining autonomic function and related haemodynamic variables in pregnant women with and without inappropriate sinus tachycardia
timeFrame: Up to 3 years
measure: Assessment of autonomic function and related haemodynamic variables in pregnant women with and without inappropriate sinus tachycardia
timeFrame: Up to 3 years
measure: Assessment of autonomic function and related haemodynamic variables in pregnant women with and without inappropriate sinus tachycardia
timeFrame: Up to 3 years
Secondary outcomes:
measure: Assessment of ANS function in pregnant women with and without IST, at rest and during mild exercise
timeFrame: Up to 3 years
measure: Assessment of ANS function in pregnant women with and without IST, at rest and during mild exercise
timeFrame: Up to 3 years
measure: Assessment of ANS function in pregnant women with and without IST, at rest and during mild exercise
timeFrame: Up to 3 years
measure: Assessment of ANS function in pregnant women with and without IST, at rest and during mild exercise
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
Study officials:
affiliation: Cambridge University Hospitals NHS Foundation Trust
name: Mark Belham
role: PRINCIPAL_INVESTIGATOR
References: