Oral Combined Hydrochlorothiazide/Lisinopril Versus Oral Nifedipine for Postpartum Hypertension

NCT ID: NCT05049616

Last Updated: 2025-11-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-18
• Study Completion Date: 2023-09-01

Brief Summary

The purpose of this study is to see if a combined pill of Angiotensin-converting enzyme (ACE) inhibitors (a medication that helps relax your veins and arteries to lower your blood pressure) with diuretics (sometimes called water pills, help rid your body of salt and water) will control blood pressure better than a different blood pressure medication of calcium channel blocker (lower your blood pressure by preventing calcium from entering the cells of your heart and arteries). Both medications are part of our usual care for high blood pressure after delivery.

Detailed Description

In individuals with preeclampsia, persistent hypertension and edema result in part from the mobilization of up to 8 liters of fluid and sodium from the extravascular to intravascular space. The increased urinary sodium excretion on days 3-5 postpartum likely results from higher atrial natriuretic peptide concentrations in plasma and activation of the renin-angiotensin-aldosterone system. Adding diuretics for postpartum hypertension has been associated with better blood pressure control in some of the studies.

• CVD is the leading cause for mortality worldwide.
• Primary prevention is more effective than treating CVD.
• Pregnancy is often the 1st adult engagement with the healthcare system.
• Preeclampsia is a risk factor for long term CVD, even after controlling for mutual risk factors.
• CVD is the leading cause for pregnancy related mortality.
• There is no good data regarding the optimal medications to control blood pressure after delivery.
• ACE inhibitors play an important role in controlling blood pressure outside of pregnancy and there is extensive evidence to support their cardioprotective effects.
• The optimal use of diuretics in the postpartum in patients with preeclampsia, require further study and clarification to augment current management schemes.

Hypothesis: that in postpartum women with hypertensive disorders, oral combined Hydrochlorothiazide/Lisinopril will reduce postpartum hypertension at 7 days after delivery compared to usual care with calcium channel blockers.

Conditions

Hypertension in Pregnancy; Postpartum Preeclampsia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hctz/Lisinopril

Hctz/Lisinopril for postpartum management of hypertension. either a combined pill of ACE inhibitors and diuretics (Hydrochlorothiazide/Lisinopril)

Group Type: EXPERIMENTAL

ACE Inhibitors and Diuretics

Intervention Type: DRUG

Hctz/Lisinopril (brand name: Zestoretic)

Extended release nifedipine

calcium channel blocker (Nifedipine

Group Type: ACTIVE_COMPARATOR

NIFEdipine ER

Intervention Type: DRUG

Extended release nifedipine

Interventions

ACE Inhibitors and Diuretics

Hctz/Lisinopril (brand name: Zestoretic)

Intervention Type: DRUG

NIFEdipine ER

Extended release nifedipine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Postpartum women at ≥ 18 years of age
• Postpartum diagnosis of persistent hypertension (2 measurements of Systolic BP ≥150 and/or diastolic BP ≥ 100 or systolic BP ≥140 and/or diastolic BP ≥ 90 for people with diabetes) requiring an oral medication based on the ACOG criteria or
• Hypertensive disorder of pregnancy diagnosed antepartum or intrapartum requiring blood pressure medication in the postpartum
• Chronic hypertension requiring blood pressure medication postpartum

Exclusion Criteria

• Urine output < 30 cc/h prior to screening for eligibility
• Creatinine > 1.4 during current admission
• End-stage renal disease
• Hypersensitivity to ACE inhibitors or sulfa drugs
• Idiopathic/hereditary angioedema
• Hyperkalemia (serum potassium >5 mEq/L) during current admission
• Pulmonary edema

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Michal Fishel Bartal

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michal Fishel Bartal, MD

Role: PRINCIPAL_INVESTIGATOR

UT Health Science Center

Locations

University of Texas Health Science Center

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HSC-MS-21-0476

Identifier Type: -

Identifier Source: org_study_id