Oral Combined Hydrochlorothiazide/Lisinopril Versus Oral Nifedipine for Postpartum Hypertension

Overview

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.

Full Title of Study: “Oral Combined Hydrochlorothiazide/Lisinopril Versus Oral Nifedipine for Postpartum Hypertension: A Comparative Effectiveness Pilot Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 26, 2022

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.

Interventions

  • Drug: ACE Inhibitors and Diuretics
    • Hctz/Lisinopril (brand name: Zestoretic)
  • Drug: NIFEdipine ER
    • Extended release nifedipine

Arms, Groups and Cohorts

  • Experimental: Hctz/Lisinopril
    • Hctz/Lisinopril for postpartum management of hypertension. either a combined pill of ACE inhibitors and diuretics (Hydrochlorothiazide/Lisinopril)
  • Active Comparator: Extended release nifedipine
    • calcium channel blocker (Nifedipine

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants With Stage 2 Hypertension
    • Time Frame: 7-10 after delivery
    • Stage 2 hypertension at day 7-10 after delivery (defined as SBP ≥ 140 and/or DBP ≥ 90 mmHg) or admission to the hospital for blood pressure control prior to day 10. Primary outcome will be calculated as the average BP reading for day 7-10 after delivery.

Secondary Measures

  • Number of Participants With Severe Postpartum Hypertension
    • Time Frame: 7-10 after delivery
    • severe postpartum hypertension (SBP≥160 and/or DBP≥110 mmHg on 2 occasions, 15 minutes apart)
  • Number of Participants Who Received Additional Antihypertensive During Admission
    • Time Frame: 7-10 days postpartum
    • number of participants who received additional antihypertensive during admission, at 7-10 days postpartum.
  • Postpartum Length of Stay
    • Time Frame: up to 30 days after delivery
    • time spent in hospital following delivery
  • Postpartum Readmission
    • Time Frame: up to 30 days after delivery
    • occurrence of returning to hospital for admission postpartum
  • Time to Blood Pressure Control
    • Time Frame: 10 days
    • The time from delivery to Blood Pressure control (i.e time from delivery to last BP <150/100).
  • Incidence of Persistent Postpartum Hypertension
    • Time Frame: 6 weeks postpartum
    • Incidence of persistent postpartum hypertension 6 weeks postpartum (SBP ≥ 140 and/or DBP ≥ 90 mmHg).
  • Occurrence of Proteinuria
    • Time Frame: 7-10 days, and 6 weeks postpartum
    • Proteinuria is measured by urine protein creatinine ratio
  • Presense of Labs Abnormality
    • Time Frame: 7-10 days, and 6 weeks postpartum
    • Labs abnormality including hyperkalemia or creatinine increase
  • Compliance With Medications
    • Time Frame: at the time of the 1st postpartum clinic visit, which is about 6 to 37 days after birth
    • Compliance with medications. The patient will be asked to bring their medication bottle with them and the compliance will be measured by counting pills at each postpartum visit.
  • Time to Control Blood Pressure
    • Time Frame: 3 month-1 year
    • Blood pressure at 3 month, 6 month, 9 month, 1 year after delivery and need for BP medications. Definition of controlled blood pressure is (SBP < 140 and/or DBP < 90 mmHg). This will be assessed by telephone encounter with the patient
  • Percentage of Patients Receiving Primary Care With BP Measurement
    • Time Frame: 1 year postpartum
    • Percentage of patients receiving primary care with BP measurement at 1 year
  • Postpartum Complications- Number of Participants With ICU Admission
    • Time Frame: 10 days postpartum
    • Need for ICU admission
  • Postpartum Complications- Number of Participants With HELLP (Hemolysis, Elevated Liver Enzymes and Low Platelets) Syndrome
    • Time Frame: 10 days postpartum
    • Hemolysis, elevated liver enzymes, low platelet count: HELLP
  • Postpartum Complications- Number of Participants With Eclampsia
    • Time Frame: 10 days postpartum
    • Eclampsia, which is considered a complication of severe preeclampsia, is commonly defined as new onset of grand mal seizure activity and/or unexplained coma during pregnancy or postpartum in a woman with signs or symptoms of preeclampsia.
  • Postpartum Complications- Number of Participants With Stroke
    • Time Frame: 10 days postpartum
    • Stroke
  • Postpartum Complications- Number of Participants With Renal Failure
    • Time Frame: 10 days postpartum
    • Renal failure
  • Postpartum Complications- Number of Participants With Pulmonary Edema
    • Time Frame: 10 days postpartum
    • Pulmonary edema
  • Postpartum Complications – Number of Participants With Cardiomyopathy
    • Time Frame: 10 days postpartum
    • Cardiomyopathy
  • Postpartum Complications- Number of Participants With Maternal Death
    • Time Frame: 10 days postpartum
    • Maternal death
  • Receipt of Additional Antihypertensive During Admission
    • Time Frame: 6 weeks postpartum
    • Receipt of additional antihypertensive during admission at 6 weeks postpartum

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The University of Texas Health Science Center, Houston
  • Provider of Information About this Clinical Study
    • Principal Investigator: Michal Fishel Bartal, Assistant Professor – The University of Texas Health Science Center, Houston
  • Overall Official(s)
    • Michal Fishel Bartal, MD, Principal Investigator, UT Health Science Center

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