Clinical trial NCT05049616: Oral Combined Hydrochlorothiazide/Lisinopril Versus Oral Nifedipine for Postpartum Hypertension
Official title: Oral Combined Hydrochlorothiazide/Lisinopril Versus Oral Nifedipine for Postpartum Hypertension: A Comparative Effectiveness Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Hypertension in Pregnancy
Postpartum Preeclampsia
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2021-09-20
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized control trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants With Stage 2 Hypertension
timeFrame: 7-10 after delivery
Secondary outcomes:
measure: Number of Participants With Severe Postpartum Hypertension
timeFrame: 7-10 after delivery
measure: Number of Participants Who Received Additional Antihypertensive During Admission
timeFrame: 7-10 days postpartum
measure: Postpartum Length of Stay
timeFrame: up to 30 days after delivery
measure: Postpartum Readmission
timeFrame: up to 30 days after delivery
measure: Time to Blood Pressure Control
timeFrame: 10 days
measure: Incidence of Persistent Postpartum Hypertension
timeFrame: 6 weeks postpartum
measure: Occurrence of Proteinuria
timeFrame: 7-10 days, and 6 weeks postpartum
measure: Presense of Labs Abnormality
timeFrame: 7-10 days, and 6 weeks postpartum
measure: Compliance With Medications
timeFrame: at the time of the 1st postpartum clinic visit, which is about 6 to 37 days after birth
measure: Time to Control Blood Pressure
timeFrame: 3 month-1 year
measure: Percentage of Patients Receiving Primary Care With BP Measurement
timeFrame: 1 year postpartum
measure: Postpartum Complications- Number of Participants With ICU Admission
timeFrame: 10 days postpartum
measure: Postpartum Complications- Number of Participants With HELLP (Hemolysis, Elevated Liver Enzymes and Low Platelets) Syndrome
timeFrame: 10 days postpartum
measure: Postpartum Complications- Number of Participants With Eclampsia
timeFrame: 10 days postpartum
measure: Postpartum Complications- Number of Participants With Stroke
timeFrame: 10 days postpartum
measure: Postpartum Complications- Number of Participants With Renal Failure
timeFrame: 10 days postpartum
measure: Postpartum Complications- Number of Participants With Pulmonary Edema
timeFrame: 10 days postpartum
measure: Postpartum Complications - Number of Participants With Cardiomyopathy
timeFrame: 10 days postpartum
measure: Postpartum Complications- Number of Participants With Maternal Death
timeFrame: 10 days postpartum
measure: Receipt of Additional Antihypertensive During Admission
timeFrame: 6 weeks postpartum
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Health Science Center
state: Texas
Study officials:
affiliation: UT Health Science Center
name: Michal Fishel Bartal, MD
role: PRINCIPAL_INVESTIGATOR
References: