Inappropriate Sinus TachycardiaPRISTNCT03317249
Pregnancy Related Inappropriate Sinus Tachycardia
An observational study of Inappropriate Sinus Tachycardia and Pregnancy Related, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
A feasibility study into the exploration of possible mechanisms underlying inappropriate sinus tachycardia (IST) syndrome in pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Inappropriate Sinus Tachycardia, Pregnancy Related
- What is being tested?
- ECG, heart rate monitor and Autonomic Nervous System (ANS) Activity
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Oct 2017to 6 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Hospital clinics (cardiology clinics and antenatal clinics)
Who may be able to join
- 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:
- Pregnant women with IST ii. Pregnant women without IST
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Addenbrookes Hospital
Cambridge, CB2 0QQ
Mark Belham
About this study
Official title: Pregnancy Related Inappropriate Sinus Tachycardia Syndrome Study
A feasibility study into the exploration of possible mechanisms underlying inappropriate sinus tachycardia (IST) syndrome in pregnancy.
Read the 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.
- Conditions
- Inappropriate Sinus Tachycardia, Pregnancy Related
- Being tested
- ECG, heart rate monitor, Autonomic Nervous System (ANS) Activity, Haemodynamic variables, Echocardiogram
- Keywords
- Inappropriate Sinus Tachycardia, Pregnancy Related, IST
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECGDiagnostic test
12-lead electrocardiogram
heart rate monitorDiagnostic test
24-hour heart rate monitor used to calculate mean heart rate and heart rate variability
Autonomic Nervous System (ANS) ActivityDiagnostic test
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 variablesDiagnostic test
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.
EchocardiogramOther
optional (for non-IST participants only)
| Study group | Role | What they receive |
|---|---|---|
| Pregnant Healthy | Pregnant females aged between 18-45 years who do not have IST syndrome Receives: Diagnostic Test: ECG; Diagnostic Test: heart rate monitor; Diagnostic Test: Autonomic Nervous System (ANS) Activity; Diagnostic Test: Haemodynamic variables; Other: Echocardiogram | |
| Pregnant IST | Pregnant females aged between 18-45 years who have IST syndrome Receives: Diagnostic Test: ECG; Diagnostic Test: heart rate monitor; Diagnostic Test: Autonomic Nervous System (ANS) Activity; Diagnostic Test: Haemodynamic variables |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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)
Measured: Up to 3 years
Secondary outcomes (4)
Assessment of ANS function in pregnant women with and without IST, at rest and during mild exercise
Stroke volume in ml
Measured: 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.
Measured: 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
Measured: 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
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start6 Oct 2017
- Primary completion6 Oct 2020 (estimated)
- Study completion6 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inappropriate Sinus TachycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Mark Belham, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Mark Belham, Principal investigator, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03317249
- Sponsor's protocol ID
- PRIST
- Acronym
- PRIST
- Status last verified
- Jan 2019
- First submitted
- 6 Oct 2017
- Last updated
- 22 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy Related Inappropriate Sinus Tachycardia Syndrome Study
- ClinicalTrials.gov ID
- NCT03317249
- Acronym / sponsor ID
- PRIST / PRIST
- Conditions
- Inappropriate Sinus Tachycardia, Pregnancy Related
- Keywords
- Inappropriate Sinus Tachycardia, Pregnancy Related, IST
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 6 Oct 2017 (actual)
- Primary completion
- 6 Oct 2020 (estimated)
- Study completion
- 6 Oct 2020 (estimated)
- First posted
- 23 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant Healthy | – | Diagnostic Test: ECG, Diagnostic Test: heart rate monitor, Diagnostic Test: Autonomic Nervous System (ANS) Activity, Diagnostic Test: Haemodynamic variables, Other: EchocardiogramPregnant females aged between 18-45 years who do not have IST syndrome |
| Pregnant IST | – | Diagnostic Test: ECG, Diagnostic Test: heart rate monitor, Diagnostic Test: Autonomic Nervous System (ANS) Activity, Diagnostic Test: Haemodynamic variablesPregnant females aged between 18-45 years who have IST syndrome |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Hospital clinics (cardiology clinics and antenatal clinics)
Key inclusion criteria (4 listed)
- 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:
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECG12-lead electrocardiogram | Diagnostic test | Pregnant Healthy, Pregnant IST |
| heart rate monitor24-hour heart rate monitor used to calculate mean heart rate and heart rate variability | Diagnostic test | Pregnant Healthy, Pregnant IST |
| Autonomic Nervous System (ANS) ActivityHeart 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 | Pregnant Healthy, Pregnant IST |
| Haemodynamic variablesCardiac 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. | Diagnostic test | Pregnant Healthy, Pregnant IST |
| Echocardiogramoptional (for non-IST participants only) | Other | Pregnant Healthy |
Primary outcome
Feasibility of examining autonomic function and related haemodynamic variables in pregnant women with and without inappropriate sinus tachycardia
Time frame: Up to 3 years
Number 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 tachycardia
Time frame: Up to 3 years
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.
Assessment of autonomic function and related haemodynamic variables in pregnant women with and without inappropriate sinus tachycardia
Time frame: Up to 3 years
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)
4 secondary outcomes
Assessment of ANS function in pregnant women with and without IST, at rest and during mild exercise
Time frame: Up to 3 years
Assessment of ANS function in pregnant women with and without IST, at rest and during mild exercise
Time frame: Up to 3 years
Assessment of ANS function in pregnant women with and without IST, at rest and during mild exercise
Time frame: Up to 3 years
Assessment of ANS function in pregnant women with and without IST, at rest and during mild exercise
Time frame: Up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Belham principal investigator
Cambridge University Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inappropriate Sinus Tachycardia and Pregnancy Related, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark Belham (01223 349154, mark.belham@addenbrookes.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of examining autonomic function and related haemodynamic variables in pregnant women with and without inappropriate sinus tachycardia (time frame: Up to 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2019.