NIFEdipine ER
DrugInitiation of nifedipine ER postpartum at randomly assigned threshold during the first 6 weeks postpartum.
Other names: Procardia XL, Adalat XL
NCT Number: NCT06220721
The long-term goal of our work is to evaluate the effect of intensive postpartum blood pressure control on maternal cardiovascular health, risk of chronic hypertension, and reversal of vascular dysfunction generated by hypertensive disorders of pregnancy, thus attenuating the lifelong trajectory of cardiovascular disease risk.
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Northwestern University, Chicago, Illinois, United States
The REPAIR trial is a multicenter randomized controlled trial of 618 postpartum patients with hypertensive disorders of pregnancy randomized to intensive blood pressure control versus usual care during the first 6 weeks postpartum. The intervention group will receive intensive blood pressure (BP) control with nifedipine extended-release initiation when BP is ≥ 140/90 mmHg. The active control group will receive usual care with nifedipine ER initiation when BP is ≥ 150/100. The study will take place at two clinical sites: Medical College of Wisconsin (MCW) and Northwestern University (NU). All participants will undergo BP monitoring, cardiovascular function assessment, and collection of cardiovascular biomarkers at baseline, 6 weeks, and 12 months postpartum. Specifically, cardiac function and structure will be assessed with transthoracic echocardiogram, endothelial dysfunction with brachial artery flow-mediated dilation, and arterial stiffness with carotid-femoral pulse wave velocity. The primary outcome is the incident diagnosis of stage I hypertension at one year postpartum.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Initiation of nifedipine ER postpartum at randomly assigned threshold during the first 6 weeks postpartum.
Other names: Procardia XL, Adalat XL
Time frame: One year postpartum
Diagnosis of chronic hypertension, defined as stage I hypertension with BP >130/80 mmHg
Time frame: One year postpartum
Brachial artery flow-mediated dilation will assess endothelial dysfunction.
Time frame: One year postpartum
Carotid-femoral pulse wave velocity will assess arterial stiffness.
Time frame: One year postpartum
Transthoracic echocardiogram will assess cardiac structure and function.
Time frame: After birth through one year postpartum
Unplanned hospital readmissions, emergency department visits, and clinic visits.
Time frame: After birth through one year postpartum
Maternal core outcomes of preeclampsia using PMID: 32674052 reference.
Time frame: After birth through one year postpartum
The score (0-100) will be calculated using American Heart Association application.
Time frame: After birth through one year postpartum
Blood pressure >160/110 mmHg
Time frame: One year postpartum
Lifetime risk calculated for subjects >20 years and 10-year risk calculated for subjects > 40 years.
Time frame: One year postpartum
Soluble fms-like tyrosine kinase (sFlt-1), Lipoprotein (a), TNF-alpha, IL-6, NT-proBNP, CRP, high-sensitivity troponin
Time frame: After birth through one year postpartum
Assessed with Infant Feeding Practices Postnatal Questionnaires
Contact information is provided by the study sponsor or research team.
Alyssa M Hernandez, DO
CONTACT
Amandla Stanley, MSN
CONTACT
Medical College of Wisconsin
Other
Acronym: REPAIR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07361679
Cardiovascular Diseases, Female Urogenital Diseases and Pregnancy Complications
Athens, Attica, Greece
View Trial DetailsNCT07656532
Cardiovascular Diseases, Diabetes Mellitus
Salamanca, SALAMANCA, Spain
View Trial DetailsNCT05655936
Body Weight, Cardiovascular Diseases
Pittsburgh, Pennsylvania, United States
View Trial DetailsNCT05849103
Cardiovascular Diseases, Female Urogenital Diseases and Pregnancy Complications
Nashville, Tennessee, United States
View Trial Details