Oral Combined Hydrochlorothiazide/Lisinopril Versus Oral Nifedipine for Postpartum Hypertension

Phase

Condition

Stress

Vascular Diseases

Williams Syndrome

Treatment

ACE Inhibitors and Diuretics

NIFEdipine ER

Clinical Study ID

NCT05049616

HSC-MS-21-0476

Ages > 18
Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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

Study Design

ACE Inhibitors and Diuretics

October 18, 2021

September 01, 2023

Study 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.

Connect with a study center

University of Texas Health Science Center
Houston, Texas 77030
United States
Site Not Available
University of Texas Health Science Center
Houston 4699066, Texas 4736286 77030
United States
Site Not Available

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