Can Atorvastatin Improve Vascular Function in Women With a History of Preeclampsia? (PVS3)
Can Atorvastatin Improve Vascular Function in Women With a History of Preeclampsia? A Randomised, Double-blinded, Placebo-controlled Crossover Trial of Atorvastatin in Women With a History of Preeclampsia.
Studieoversikt
Detaljert beskrivelse
Women with a history of preeclampsia (high blood pressure/protein in the urine during pregnancy) are at increased risk of developing high blood pressure and heart problems in the 10-15 years after their baby is born. At present we do not know how to reduce this risk. Lowering blood pressure and blood lipid (fats) levels are common strategies for primary prevention of cardiovascular problems. However, most women with a history of preeclampsia in the 5-10 years after pregnancy, will have normal blood pressure readings, blood sugar and cholesterol levels.
Atorvastatin, a type of "statin", is widely used in lowering lipids and preventing cardiovascular disease. This drug has beneficial actions other than lipid-lowering, that may also help prevent cardiovascular problems, including improving function in the lining of blood vessels. We know that impairment in blood vessel function is evident in women in the years after a preeclamptic pregnancy and may contribute to the risk of women after preeclampsia going on to develop cardiovascular disease.
We would like to know if giving a short course of atorvastatin to women with a history of preeclampsia improves their blood vessel function. To do this, ex-preeclamptic women will be invited to take either a atorvastatin or placebo ("dummy") tablet daily for 4 weeks, then no tablets for 4 weeks, then "crossover" to receive the alternative tablet (placebo or atorvastatin) daily for 4 weeks. Blood vessel function would be measured using specialised noninvasive scans and taking a blood test at the beginning and end of each treatment period. The study will be jointly run by the Departments of Cardiovascular Medicine and Obstetrics & Gynaecology at the John Radcliffe Hospital, Oxford.
We anticipate this study will provide valuable data to support larger clinical trials to determine whether improving blood vessel function ultimately reduces the risk of developing early-onset cardiovascular disease after preeclampsia.
Studietype
Registrering (Faktiske)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
-
-
-
Oxford, Storbritannia, OX3 9DU
- University of Oxford Department of Cardiovascular Medicine
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Participant is willing and able to give informed consent for participation in the study.
- Diagnosed with preeclampsia during index pregnancy: defined as (1) new onset hypertension (>140/90 mmHg) after 20 weeks gestation and (2) proteinuria (>0.3g protein/24 hours).
- Participants of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 4 weeks after.
- Participants must be willing to undertake urine pregnancy test at the start of each 4 week phase of the study to exclude unintended pregnancy.
- Participants must have clinically acceptable laboratory markers of renal, thyroid and hepatic function at enrolment.
- Able (in the Investigator's opinion) and willing to comply with all study requirements.
- Willing to allow her General Practitioner and consultant, if appropriate, to be notified of participation in the study and results of clinical laboratory tests.
Exclusion Criteria:
Participants must not be
- Pregnant, lactating during the course of the study.
- Planning pregnancy during course of study or in 4 weeks after study completion
- Taking other medication, whether prescribed or over-the-counter, in the four weeks before first study dose and during the study other than for example mild analgesia or hormonal contraception.
- Taking vitamin medications that may interact with atorvastatin (e.g. niacin, Vitamin D)
- Terminally ill or is inappropriate for placebo medication
- Planning to undertake donation of blood during the study.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Atorvastatin first
Participants receive 4 week treatment with atorvastatin 20mg/day, followed by 4 week washout, followed by 4 week treatment with placebo.
|
4 week treatment, 20mg/day taken orally in tablet form
|
|
Eksperimentell: Placebo first
Participants receive 4 week treatment with placebo, followed by 4 weeks washout, followed by 4 weeks treatment with atorvastatin 20mg/day.
|
4 week treatment, 20mg/day taken orally in tablet form
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Alteration in brachial artery flow-mediated dilatation
Tidsramme: After 4 weeks treatment with atorvastatin or placebo
|
After 4 weeks treatment with atorvastatin or placebo
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Microvascular endothelial function as measured by laser doppler flowmetry
Tidsramme: After 4 weeks treatment with atorvastatin or placebo
|
After 4 weeks treatment with atorvastatin or placebo
|
|
Resistance vessel endothelial function as measured by venous occlusion plethysmography
Tidsramme: After 4 weeks treatment with atorvastatin or placebo
|
After 4 weeks treatment with atorvastatin or placebo
|
|
Indices of arterial stiffness as measured by arterial tonometry and carotid artery distensibility
Tidsramme: After 4 weeks treatment with atorvastatin or placebo
|
After 4 weeks treatment with atorvastatin or placebo
|
|
Plasma biomarkers of inflammation and endothelial function
Tidsramme: After 4 weeks treatment with atorvastatin or placebo
|
After 4 weeks treatment with atorvastatin or placebo
|
|
Endothelial glycocalyx as measured by sublingual Microscan
Tidsramme: After 4 weeks treatment with atorvastatin or placebo
|
After 4 weeks treatment with atorvastatin or placebo
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Paul Leeson, PhD MRCP FESC, University of Oxford
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2008-005759-21
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .