NIFEdipine ER for Reducing High Blood Pressure After Preeclampsia
(REPAIR Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Medical College of Wisconsin
Disqualifiers: Pre-gestational hypertension, Diabetes, ICU admission, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?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.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug NIFEdipine ER for reducing high blood pressure after preeclampsia?
Research shows that nifedipine, a component of NIFEdipine ER, effectively controls high blood pressure in women with preeclampsia, as it was able to lower blood pressure in most patients and prolong pregnancies. Additionally, it has been found to have a positive effect on platelet counts, which is beneficial in managing preeclampsia.
12345Is Nifedipine safe for humans?
Nifedipine has been shown to be generally safe for humans, with studies indicating it effectively controls blood pressure in severe preeclampsia with minor side effects. It is considered a convenient and low-cost treatment option without undesirable side effects.
12367How does the drug NIFEdipine ER differ from other treatments for high blood pressure after preeclampsia?
NIFEdipine ER is unique because it is an extended-release form of nifedipine, which helps manage high blood pressure more effectively by providing a steady release of medication over time. It is shown to be faster in reducing blood pressure compared to labetalol and is effective in preventing severe hypertension during pregnancy, making it a convenient and low-cost option for managing severe preeclampsia.
14789Eligibility Criteria
This trial is for women aged 18-50 who have had high blood pressure or preeclampsia during pregnancy, can communicate in English or Spanish, and are within the first three days after giving birth. It's not for those with pre-pregnancy hypertension or diabetes, planning to transfer hospitals postpartum, allergic to nifedipine, or unable to consent.Inclusion Criteria
I am between 18 and 50 years old.
I can communicate in either English or Spanish.
Postpartum day 0-3 and prior to discharge
+1 more
Exclusion Criteria
Pre-gestational hypertension
I had diabetes before getting pregnant.
Intent to transfer postpartum to an outside institution of the participating centers
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Intensive postpartum blood pressure control with nifedipine ER initiation for 6 weeks postpartum
6 weeks
Regular visits for blood pressure monitoring
Follow-up
Participants are monitored for cardiovascular health, including BP monitoring and cardiovascular function assessment at 6 weeks and 12 months postpartum
12 months
Visits at 6 weeks and 12 months postpartum
Participant Groups
The study tests whether intensive blood pressure control using NIFEdipine ER after childbirth can improve heart health, lower the risk of long-term high blood pressure, and reverse vascular damage caused by hypertensive disorders during pregnancy.
2Treatment groups
Experimental Treatment
Active Control
Group I: REPAIR ARMExperimental Treatment1 Intervention
Intensive postpartum blood pressure control with nifedipine ER initiation at systolic blood pressure (SBP) ≥140 mmHg or diastolic blood pressure (DBP) ≥90 mmHg and maintaining blood pressure \<140/90 mmHg during the first 6 weeks postpartum.
Group II: CONTROL ARMActive Control1 Intervention
Usual care with nifedipine ER initiation at SBP ≥150 mmHg or DBP ≥100 mmHg and maintaining blood pressure \<150/100 mmHg during the first 6 weeks postpartum.
NIFEdipine ER is already approved in European Union, United States, Canada for the following indications:
🇪🇺 Approved in European Union as Nifedipine for:
- Hypertension
- Angina pectoris
- Vasospastic angina
🇺🇸 Approved in United States as Nifedipine for:
- Hypertension
- Angina pectoris
- Vasospastic angina
- Chronic stable angina
🇨🇦 Approved in Canada as Nifedipine for:
- Hypertension
- Angina pectoris
- Vasospastic angina
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Medical College of WisconsinMilwaukee, WI
Northwestern UniversityChicago, IL
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Who Is Running the Clinical Trial?
Medical College of WisconsinLead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Collaborator
References
Trial of Intrapartum Extended-Release Nifedipine to Prevent Severe Hypertension Among Pregnant Individuals With Preeclampsia With Severe Features. [2023]Preeclampsia is associated with maternal and perinatal morbidity. Besides acute therapy for severe hypertension, best practices are lacking for intrapartum hypertension management. Our objective was to test the hypothesis that intrapartum initiation of extended-release nifedipine in individuals with preeclampsia with severe features prevents severe hypertension.
[Clinical efficacy and perinatal outcome of nifedipine for severe preeclampsia: meta-analysis]. [2013]To assess the efficacy, side effects and perinatal outcome of nifedipine compared with other antihypertensives for treating severe preeclampsia in pregnant women.
Hemodynamic effects of oral nifedipine in preeclamptic hypertensive emergencies. [2019]Our purpose was to evaluate the hemodynamic effects of oral nifedipine in preeclamptic hypertensive emergencies.
Oral nifedipine and phytosterol, intravenous nicardipine, and oral nifedipine only: Three-arm, retrospective, cohort study for management of severe preeclampsia. [2023]The treatment of preeclampsia is delivering women and extracting the placenta, but the Chinese Society of Obstetrics and Gynecology guidelines do not recommend the delivery of babies without severe features. The objectives of the study were to compare the effectiveness and safety of nifedipine and phytosterol in combination with nicardipine for the management of severe preeclampsia. Women (19-32 years; gestation age ≥ 30 weeks) with the complication of severe preeclampsia have received 10 mg of oral nifedipine (pregnant women received 10 mg of oralnifedipine, n = 112) or 1 mg/h intravenous nicardipine (pregnant women received 1 mg/h intravenous nicardipine (ND cohort), n = 115) or oral 10 mg nifedipine and 500 mg phytosterol (pregnant women received oral 10 mg nifedipine and 500 mg phytosterol (np cohort), n = 111) until 150/100 mmHg blood pressure was achieved. The time required to achieve the desired blood pressure control was 13 minutes shorter in the NP cohort compared to the NF (p < 0.0001, t = 11.605), and 3 minutes shorter compared to the ND (p < 0.0001, t = 2.79) cohorts. Stillbirths were reported in 14 (13%), 28 (24%), and 10 (9%) infants, and 13 (12%), 26 (23%), and 10 (9%) infants died from the NF, ND, and NP cohorts, respectively. The undesirable tocolytic effect was reported in 17 (15%) women of the ND cohort. Phytosterol with nifedipine has a synergistic or additive effect on the management of preeclampsia with fewer adverse outcomes.
Nifedipine and platelets in preeclampsia. [2019]In addition to its antihypertensive properties, nifedipine inhibits platelet aggregation in vitro. Because increased platelet aggregation is a feature of preeclampsia, we have investigated nifedipine in this condition. Ten women at 31 +/- 2.8 weeks gestation, with blood pressure 162 +/- 18/102 +/- 10 mmHg (despite atenolol 200 mg/day) and proteinuria 2.0 +/- 1.1 g/24 hr, were treated with nifedipine. Pregnancies were prolonged by 17 +/- 15 days (range 5 to 56). Blood pressure was controlled in eight of the ten patients, final values before delivery being 142 +/- 16/89 +/- 12 mmHg (P less than 0.02). Platelet count rose in all women from 190 +/- 80 to 261 +/- 78 X 10(9)/1 (P less than 0.001). Nifedipine appears to reverse the thrombocytopenia of pre-eclampsia, in addition to controlling the blood pressure.
Long-term treatment with nicardipine for severe pre-eclampsia. [2019]To evaluate the safety of long-term nicardipine treatment in severely pre-eclamptic women and their fetuses/newborns.
Nifedipine in the treatment of severe preeclampsia. [2013]We conducted a randomized clinical trial in which patients with severe preeclampsia between 26-36 weeks of gestation received either nifedipine (10-30 mg sublingually, then 40-120 mg/day orally; N = 24) or hydralazine (6.25-12.5 mg intravenously, then 80-120 mg/day orally; N = 25). Effective control of blood pressure was achieved with nifedipine in 95.8% of subjects and with hydralazine in 68%, a statistically significant difference (P less than .05). Maternal side effects were minor in both groups. Acute fetal distress developed in one nifedipine subject and in 11 treated with hydralazine. Mean prolongation of gestation was 15.5 +/- 10 days with nifedipine and 9.5 +/- 11 days with hydralazine, a difference that did not reach statistical significance (P less than .07). Infants born to women treated with nifedipine were delivered at more advanced gestational ages (34.6 +/- 2.3 versus 33.6 +/- 2.4 weeks; statistically not significant), weighed more (1826 +/- 456 versus 1580 +/- 499 g; statistically not significant), and tended to have fewer, mainly minor, complications. The average number of days spent in the neonatal intensive care unit was significantly lower in the nifedipine group (15.1 versus 32.7 days; P less than .005), leading to an average 31% reduction in total (maternal and neonatal) hospitalization-related charges for each nifedipine-treated pregnancy. We conclude that nifedipine is an effective, convenient, and low-cost treatment for patients with severe preeclampsia, and is not associated with undesirable side effects.
A trial of oral nifedipine and oral labetalol in preeclampsia hypertensive emergency treatment. [2018]This observational retrospective cohort study was conducted to compare oral nifedipine and labetalol for emergency treatment of hypertension in preeclamptic patients. Time (minutes) and necessary doses were outlined to achieve blood pressure lower than 150/95 mmHg. In 14 patients with preeclampsia, 55 hypertensive emergencies were identified (BP >150/95). Of these emergencies, 43 were treated with oral nifedipine 10 mg (10 patients) and 12 with oral labetalol 100 mg (4 patients). To achieve a target blood pressure under 150/95, these doses were repeated as necessary every 20 min, up to a maximum of 4 doses. Oral nifedipine reduced BP more rapidly (31.30 vs. 53.50 min, p = .03). No maternal or foetal adverse events were observed and no major differences were found according to the type of delivery. Oral nifedipine is faster than and at least as safe as labetalol in pre-eclampsia hypertensive emergency treatment.
Celastrol synergizes with oral nifedipine to attenuate hypertension in preeclampsia: a randomized, placebo-controlled, and double blinded trial. [2021]Preeclampsia, a disease mainly manifesting as serious hypertension during pregnancy, affects expectant mothers around the globe. Celastrol, a naturally existing triterpenoid, is known to exhibit beneficial effects attenuating cardiovascular symptoms including hypertension. We here assessed the treatment outcome against preeclampsia with a combined use of celastrol and nifedipine. A total of 626 patients with preeclampsia were enrolled, screened, and assigned by random to groups receiving either nifedipine + placebo or nifedipine + celastrol orally. Time required to control hypertension as well as time before another hypertensive crisis were defined as primary end points. Secondary end points include the number of dosages required to control hypertension, as well as maternal and neonatal adverse effects. The time to control hypertension showed a marked reduction in nifedipine + celastrol group, while time before a new hypertensive crisis was significantly lengthened with the treatment, compared with the nifedipine + placebo group. The number of dosages required to control hypertension was also lower in the nifedipine + celastrol group. The two treatment groups were not statistically different regarding adverse effects, either maternal or neonatal. Results from the current study provide evidence for the potential role of celastrol serving as an effective and safe adjuvant to oral nifedipine against hypertension in patients with preeclampsia.