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Trial record 17 of 136 for:    Recruiting, Not yet recruiting, Available Studies | Tachycardia

Pregnancy Related Inappropriate Sinus Tachycardia (PRIST)

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ClinicalTrials.gov Identifier: NCT03317249
Recruitment Status : Recruiting
First Posted : October 23, 2017
Last Update Posted : January 21, 2019
Sponsor:
Information provided by (Responsible Party):
Dr Mark Belham, Cambridge University Hospitals NHS Foundation Trust

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

Condition or disease Intervention/treatment
Inappropriate Sinus Tachycardia Pregnancy Related Diagnostic Test: ECG Diagnostic Test: heart rate monitor Diagnostic Test: Autonomic Nervous System (ANS) Activity Diagnostic Test: Haemodynamic variables Other: Echocardiogram

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.


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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pregnancy Related Inappropriate Sinus Tachycardia Syndrome Study
Actual Study Start Date : October 6, 2017
Estimated Primary Completion Date : October 6, 2020
Estimated Study Completion Date : October 6, 2020

Group/Cohort Intervention/treatment
Pregnant Healthy
Pregnant females aged between 18-45 years who do not have IST syndrome
Diagnostic Test: ECG
12-lead electrocardiogram

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

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.


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.

Other: Echocardiogram
optional (for non-IST participants only)

Pregnant IST
Pregnant females aged between 18-45 years who have IST syndrome
Diagnostic Test: ECG
12-lead electrocardiogram

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

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.


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.




Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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)


Secondary Outcome Measures :
  1. Assessment of ANS function in pregnant women with and without IST, at rest and during mild exercise [ Time Frame: Up to 3 years ]
    Stroke volume in ml

  2. Assessment of ANS function in pregnant women with and without IST, at rest and during mild exercise [ Time Frame: Up to 3 years ]
    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.

  3. Assessment of ANS function in pregnant women with and without IST, at rest and during mild exercise [ Time Frame: Up to 3 years ]
    Cardiac Output in litres/minute

  4. Assessment of ANS function in pregnant women with and without IST, at rest and during mild exercise [ Time Frame: Up to 3 years ]
    Blood Pressure in mm/Hg



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Hospital clinics (cardiology clinics and antenatal clinics)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03317249


Contacts
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Contact: Mark Belham 01223 349154 mark.belham@addenbrookes.nhs.uk
Contact: Katherine Stobbart 01223 596377 katherine.stobbart@addenbrookes.nhs.uk

Locations
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United Kingdom
Addenbrookes Hospital Recruiting
Cambridge, United Kingdom, CB2 0QQ
Contact: Mark Belham         
Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
Investigators
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Principal Investigator: Mark Belham Addenbrookes Hospital

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Responsible Party: Dr Mark Belham, Consultant Cardiologist, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03317249     History of Changes
Other Study ID Numbers: PRIST
First Posted: October 23, 2017    Key Record Dates
Last Update Posted: January 21, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Mark Belham, Cambridge University Hospitals NHS Foundation Trust:
Inappropriate Sinus Tachycardia
Pregnancy Related
IST
Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Sinus
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes
Tachycardia, Supraventricular