Feasibility study on the effects of L-citrulline on cardiovascular function in hypertensive pregnant women.

Phase 1

• Conditions: The medical condition that is to be investigated in this study is essential hypertension in pregnant women. In this study it is defined as diastolic BP of =90 mmHg (average of two clinic readings) or =80 mmHg if taking antihypertensive medication or pulse wave velocity =9m/s before 16 weeks’ gestation.; MedDRA version: 20.0Level: PTClassification code 10070538Term: Gestational hypertensionSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions; MedDRA version: 20.0Level: PTClassification code 10036485Term: Pre-eclampsiaSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions; MedDRA version: 20.0Level: PTClassification code 10014129Term: EclampsiaSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions; MedDRA version: 20.0Level: PTClassification code 10020772Term: HypertensionSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2015-005792-25-GB
• Lead Sponsor: Manchester University NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-11
• Study Completion: 2019-03-06
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 36

Inclusion Criteria

Viable singleton pregnancy
Gestation: 12+0 to 16+0 weeks
Aged 18 years or over at date of randomisation
Able to provide informed consent
Diastolic BP of =90 mmHg (average of two clinic readings) OR =80 mmHg if taking antihypertensive medication OR PWV =9m/s before 16 weeks’ gestation
Creatinine <120 mmol/l at booking

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 42
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

None

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified