Pregnancy Related Inappropriate Sinus Tachycardia

NCT ID: NCT03317249

Last Updated: 2019-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-06

Study Completion Date

2020-10-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Inappropriate Sinus Tachycardia Pregnancy Related

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pregnant Healthy

Pregnant females aged between 18-45 years who do not have IST syndrome

ECG

Intervention Type DIAGNOSTIC_TEST

12-lead electrocardiogram

heart rate monitor

Intervention Type DIAGNOSTIC_TEST

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

Autonomic Nervous System (ANS) Activity

Intervention Type DIAGNOSTIC_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 variables

Intervention Type DIAGNOSTIC_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.

Echocardiogram

Intervention Type OTHER

optional (for non-IST participants only)

Pregnant IST

Pregnant females aged between 18-45 years who have IST syndrome

ECG

Intervention Type DIAGNOSTIC_TEST

12-lead electrocardiogram

heart rate monitor

Intervention Type DIAGNOSTIC_TEST

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

Autonomic Nervous System (ANS) Activity

Intervention Type DIAGNOSTIC_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 variables

Intervention Type DIAGNOSTIC_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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ECG

12-lead electrocardiogram

Intervention Type DIAGNOSTIC_TEST

heart rate monitor

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

Intervention Type 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.

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Echocardiogram

optional (for non-IST participants only)

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cambridge University Hospitals NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr Mark Belham

Consultant Cardiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mark Belham

Role: PRINCIPAL_INVESTIGATOR

Cambridge University Hospitals NHS Foundation Trust

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Addenbrookes Hospital

Cambridge, , United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mark Belham

Role: CONTACT

01223 349154

Katherine Stobbart

Role: CONTACT

01223 596377

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Mark Belham

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PRIST

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Outcome of SVT in Children Admitted to AUCH
NCT07143591 NOT_YET_RECRUITING