Nifedipine ER for Postpartum High Blood Pressure

(IPAT Trial)

Recruiting in Palo Alto (17 mi)

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Medical College of Wisconsin

Disqualifiers: Pre-gestational hypertension, Pre-gestational diabetes, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

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.

Will I have to stop taking my current medications?

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 postpartum high blood pressure?

Research shows that Nifedipine, a drug that lowers blood pressure, can significantly reduce mean arterial pressure (average blood pressure in the arteries) and increase urine output in postpartum patients with severe preeclampsia, indicating its effectiveness in managing high blood pressure after childbirth. ^{1 2 3 4 5}

Is Nifedipine ER safe for treating high blood pressure in postpartum women?

Nifedipine, used for treating high blood pressure, has been studied for safety in various conditions, including pregnancy-related hypertension. Common side effects include flushing (redness and warmth in the face) and headaches, which often decrease over time. Ankle swelling may occur and might not improve with continued use. ^{1 2 6 7 8}

How is the drug Nifedipine ER unique for treating postpartum high blood pressure?

Nifedipine ER is unique because it is a calcium channel blocker that not only lowers blood pressure but also increases urine output, which can be beneficial in managing postpartum high blood pressure, especially in cases of severe preeclampsia. It also has the advantage of being taken orally, which can be more convenient compared to other treatments. ^{1 2 4 9 10}

Eligibility Criteria

This trial is for women aged 18-45 who have been diagnosed with high blood pressure or pre-eclampsia during pregnancy, according to ACOG guidelines. They must be within the first three days postpartum and able to communicate in English or Spanish. Women with pre-existing hypertension, diabetes before pregnancy, plans to transfer hospitals postpartum, nifedipine allergies, or unwillingness to consent are excluded.

Inclusion Criteria

I have been diagnosed with high blood pressure during pregnancy.

I can communicate in English or Spanish.

I am between 18 and 45 years old.

Exclusion Criteria

Known allergy to nifedipine or other significant contraindication to nifedipine

Inability or unwillingness to provide informed consent

Intent to transfer postpartum to an outside institution of the participating centers

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Intensive postpartum BP control with Nifedipine ER versus usual care for 6 weeks postpartum

6 weeks

Monthly virtual educational sessions

Follow-up

Participants are monitored for cardiovascular health, BP, and vascular function up to 12 months postpartum

12 months

Assessments at baseline, 6 weeks, and 12 months postpartum

Treatment Details

Interventions

• NIFEdipine ER (Calcium Channel Blocker)

Trial Overview The study is testing the effects of intensive blood pressure control using NIFEdipine ER after childbirth on long-term cardiovascular health. It aims to reduce chronic hypertension risk and improve vascular function affected by hypertensive disorders during pregnancy.

Participant Groups

Group I: Intervention arm Experimental Treatment 1 Intervention

Intervention group - intensive postpartum BP control with Nifedipine initiation at SBP≥140 mmHg or DBP≥90 mmHg and maintaining BP at \<140/90 mmHg during the first 6 weeks postpartum. In addition, participants will receive education on healthy lifestyle following AHA LE8.

Group II: Active control arm Active Control 1 Intervention

Active control group - a group of usual care that follows ACOG recommendations with Nifedipine initiation at SBP≥150 mmHg or DBP≥100 mm Hg and maintaining BP at \<150/100 mmHg during the first 6 weeks postpartum. In addition, participants will receive education on healthy lifestyle following AHA LE8.

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 Nearby Select from list below to view details:

Froedtert Hospital Milwaukee, WI

Who Is Running the Clinical Trial?

Medical College of Wisconsin Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

Use of nifedipine in the hypertensive diseases of pregnancy. [2017] To review the available data about the use of nifedipine to treat hypertension in pregnancy.

2. United States pubmed.ncbi.nlm.nih.gov

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.

3. China pubmed.ncbi.nlm.nih.gov

[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.

4. United States pubmed.ncbi.nlm.nih.gov

The use of nifedipine during the postpartum period in patients with severe preeclampsia. [2022] Nifedipine is a calcium channel blocker that reduces blood pressure and increases renal blood flow. This double-blind investigation evaluated the effect of nifedipine in postpartum patients with severe preeclampsia. Thirty-one patients were randomized to receive either nifedipine (10 mg) or placebo every 4 hours beginning immediately after delivery. Data analysis revealed a significantly higher urine output in the nifedipine group during the first 24 hours after delivery (3834 versus 2057 ml; p less than 0.05). A significant reduction in mean arterial pressure was also noted in the nifedipine group between 18 and 24 hours postpartum (93.9 versus 100.2 mm Hg; p less than 0.05). There were no significant differences in the systolic or diastolic blood pressures, pulse, laboratory study results, or the need to administer hydralazine to control blood pressure. Nifedipine appears to have a beneficial effect on urinary output and mean arterial pressure during the first 24 hours post partum in patients with severe preeclampsia.

5. Australia pubmed.ncbi.nlm.nih.gov

Sublingual nifedipine in human pregnancy. [2019] Nifedipine is widely used for acute lowering of blood pressure in obstetric hypertensive emergencies. It has not been approved for this indication or widely assessed.

6. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of nifedipine 20 mg tablets in hypertension using electronic data collection in general practice. [2022] Electronic data collection was used in this open study to survey the safety and efficacy of nifedipine when used in the treatment of 3972 patients with mild to moderate essential hypertension. The safety and efficacy results are presented and discussed as well as the advantages, disadvantages and reliability of electronic data collection. The validity of data collected electronically has not previously been tested, such data having been assumed to be reliable. The pattern of adverse events reported in this study is compared with the pattern of reports to the Committee on Safety of Medicine (CSM), to Bayer UK and in a large paper-based study of nifedipine, in order to test these assumptions. Reported adverse medical events pre-treatment, prior to entry to the study and noted at visit 1, were compared with reports during treatment in the study at visits 2 and 3. The expected incidence of flushing and headache was seen which diminished with continued treatment. Reductions were seen in dyspnoea and impotence. Ankle oedema was observed and was not reduced by time alone. After one month of treatment with nifedipine 20 mg tablets twice daily, 66.5% of patients had a sitting phase V diastolic blood pressure of 90 mmHg or below and 79% of 95 mmHg or below.

7. France pubmed.ncbi.nlm.nih.gov

[Adverse effects and hemodynamic effects of nifedipine as a tocolytic]. [2015] To describe maternal and fetal adverse effects, in particular cardiorespiratory, of nifedipine as tocolytic, as well as effects on hemodynamic parameters.

8. Nigeria pubmed.ncbi.nlm.nih.gov

The effect of nifedipine on oral contraceptive-induced hypertension in rats. [2013] Administration of oral contraceptive (OC) steroids is associated with an increased risk of developing hypertension, although the mechanisms underlying this effect are not well established. This study therefore sought to investigate the effect of L-type calcium channel blocker, nifedipine on OC-induced hypertension.

9. South Africa pubmed.ncbi.nlm.nih.gov

Nifedipine in acute hypertensive emergencies in pregnancy. [2014] The effect of nifedipine (Adalat; Bayer-Miles)--a calcium channel blocker, which has a well-established place in nonobstetric hypertension--was compared with dihydralazine in 33 primigravidas with severe hypertension of pregnancy. Patients with a diastolic blood pressure greater than 110 mmHg before drug administration were randomly assigned to treatment with either nifedipine or dihydralazine. Both drugs were found to be equally efficacious. Nifedipine, however, showed an earlier onset of action in lowering systolic blood pressure and had the advantage of oral administration.

10. England pubmed.ncbi.nlm.nih.gov

Nifedipine as a second line antihypertensive drug in pregnancy. [2019] Slow-release nifedipine has been used in the treatment of severe hypertension in 23 pregnant women. In 22 this was in combination with other drugs, in 18 including atenolol. Good control of blood pressure was achieved in 20 women. The perinatal mortality of the group was 130/1000, with a high caesarean section rate (71% of live-births), a high rate of abnormal CTGs, a high rate of premature delivery, and a high rate of infants who were small-for-dates. Whether this is due to the disease process or the medication is uncertain. For the present time these combinations should only be used in severe hypertensives or in the context of a controlled trial.