NCT04273854Fut, nem toboroz
Physician Optimised Post-partum Hypertension Treatment Trial
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2021. okt. 22.
Rövid összefoglaló (regiszter, angolul)
It has been shown in a pilot randomised controlled study [SNAP-HT [4]; REC 14/SC/1316] that blood pressure self-management during the post-partum period after hypertensive pregnancies, results in lower blood pressure after six months; even when medication has been stopped. The team now want to assess whether this blood pressure reduction can be reproduced in a larger, randomised, study (data analysis blinded) and whether the blood pressure lowering has additional benefits in terms of other cardiovascular and cerebrovascular changes known to occur in women who have had a hypertensive pregnancy. The investigators therefore plan to run a trial of self-management in the post-partum period, using updated Blue-tooth® enabled blood pressure monitoring coupled to physician-assisted dose titration to further advance the self-management aspect of the intervention. The physicians will be specialist clinicians who form part of the research team. The investigators will measure additional structural and functional end organ differences, using magnetic resonance imaging of the brain and heart as well as echocardiography and retinal imaging. This will provide insight into the impact of post-partum blood pressure control on the maternal cardiovascular system and how this associates with blood pressure changes. Together, these studies will help refine future intervention strategies in this cohort of patients.
- Állapot (regiszter)
- Fut, nem toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 200 (tervezett)
- Első benyújtás
- 2020. jan. 29.
- Kezdés
- 2020. febr. 21.
- Elsődleges befejezés
- 2022. ápr. 1.
- Fő szponzor
- University of Oxford
- Betegségek
- Magas vérnyomás
- NCT-szám
- NCT04273854
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 200
- 2020. febr. 21. és az elsődleges befejezés (2022. ápr. 1.) között
- 2 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Scheduled elective surgery (excluding caesarean sections) or other procedures requiring general anaesthesia during the trial.
- Participants who have participated in another research trial involving an investigational product in the past 12 weeks.
Más betegség
- Significant renal or hepatic impairment that would affect safe medication titration and adjustment as part of the trial, as deemed by the Investigator.
- Any other significant disease or disorder, which, in the opinion of the Investigator, may either, put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
- Women with pre-existing hypertension will be excluded, as this is a separate pathology that would affect the efficacy of the study intervention and affect the primary and secondary outcomes of the study.
- Additional exclusion criteria specific to the Gadolinium sub-study are:
Laborértékek
- eGFR <30ml/minute.
Egyéb
- Participant with life expectancy of less than 6 months.
- An absolute contra-indication to MRI (as per MRI safety questionnaire)
- Breast feeding,
Kiket keres a vizsgálat
- Participant is willing and able to give informed consent for participation in the trial.
- Female, aged 18 years or above.
- Clinician confirmed diagnosis of either gestational hypertension or pre-eclampsia defined by NICE NG 133
- Requiring anti-hypertensive medication at the point of discharge from secondary care.
- Participant has clinically acceptable laboratory results and clinical course post-partum with no other adverse complicating factor requiring prolonged admission post-partum that would make participation unfeasible as judged by the CI. Examples would include stroke sequalae, ongoing DIC, the baby/babies requiring prolonged NICU/SCBU admission of >1 week.
- In the Investigator's opinion, is able and willing to comply with all trial requirements including ownership of a 'Smart-phone/Tablet' and willing to use the smart-phone app if randomised to that arm.
- Sufficient competence in English Language to follow the app instructions and partake in the study, as judged by the CI
Életkor a regiszterben: 18 év – - · Nem: csak nők · Egészséges önkénteseket nem fogad
Helyszínek (2)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Cardiovascular Clinical Research Facility, Dept of Cardiovascular Medicine, University of Oxford | Oxford | Egyesült Királyság | Ismeretlen állapot |
| Oxford University Hospitals NHS Foundation Trust | Oxford | Egyesült Királyság | Ismeretlen állapot |
Kapcsolódó publikációk
- Retinal Vascular Caliber: 6 to 12 Months and 15 to 25 Years Following Hypertensive Pregnancy.Hypertension · 2026 · PMID 42305089
- Brain Volumes After Hypertensive Pregnancy and Postpartum Blood Pressure Management: A POP-HT Randomized Clinical Trial Imaging Substudy.JAMA Neurol · 2026 · PMID 41490362
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