Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2017-10-06
2020-10-06
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pregnant Healthy
Pregnant females aged between 18-45 years who do not have IST syndrome
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.
Echocardiogram
optional (for non-IST participants only)
Pregnant IST
Pregnant females aged between 18-45 years who have IST syndrome
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.
Interventions
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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.
Echocardiogram
optional (for non-IST participants only)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
45 Years
FEMALE
Yes
Sponsors
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Cambridge University Hospitals NHS Foundation Trust
OTHER
Responsible Party
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Dr Mark Belham
Consultant Cardiologist
Principal Investigators
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Mark Belham
Role: PRINCIPAL_INVESTIGATOR
Cambridge University Hospitals NHS Foundation Trust
Locations
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Addenbrookes Hospital
Cambridge, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Mark Belham
Role: primary
Other Identifiers
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PRIST
Identifier Type: -
Identifier Source: org_study_id
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