Pregnancy Related Inappropriate Sinus Tachycardia

NCT03317249 | Unknown

• 1 other identifier: PRIST
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Inappropriate Sinus Tachycardia; Pregnancy Related

Keywords

Inappropriate Sinus Tachycardia; Pregnancy Related; IST

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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)

  Up to 3 years

Secondary Outcomes (4)

• Assessment of ANS function in pregnant women with and without IST, at rest and during mild exercise

  Up to 3 years

• Assessment of ANS function in pregnant women with and without IST, at rest and during mild exercise

  Up to 3 years

• Assessment of ANS function in pregnant women with and without IST, at rest and during mild exercise

  Up to 3 years

• Assessment of ANS function in pregnant women with and without IST, at rest and during mild exercise

  Up to 3 years

Study Arms (2)

Pregnant Healthy

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

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

Diagnostic Test: ECG; Diagnostic Test: heart rate monitor; Diagnostic Test: Autonomic Nervous System (ANS) Activity; Diagnostic Test: Haemodynamic variables

Interventions

ECG DIAGNOSTIC_TEST

12-lead electrocardiogram

Pregnant Healthy; Pregnant IST

heart rate monitor DIAGNOSTIC_TEST

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

Pregnant Healthy; Pregnant IST

Autonomic Nervous System (ANS) Activity 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.

Pregnant Healthy; Pregnant IST

Haemodynamic variables 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.

Pregnant Healthy; Pregnant IST

Echocardiogram OTHER

optional (for non-IST participants only)

Pregnant Healthy

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Hospital clinics (cardiology clinics and antenatal clinics)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead

Study Sites (1)

Addenbrookes Hospital

Cambridge, CB2 0QQ, United Kingdom

RECRUITING

MeSH Terms

Interventions

Electrocardiography; Heart Rate Determination; Exercise

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Physical Examination; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Mark Belham

  Cambridge University Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark Belham

CONTACT

01223 349154; mark.belham@addenbrookes.nhs.uk

Katherine Stobbart

CONTACT

01223 596377; katherine.stobbart@addenbrookes.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Cardiologist

Study Record Dates

• First Submitted: October 6, 2017
• First Posted: October 23, 2017
• Study Start: October 6, 2017
• Primary Completion: October 6, 2020
• Study Completion: October 6, 2020
• Last Updated: January 22, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)