Oral Combined Hydrochlorothiazide/Lisinopril Versus Oral Nifedipine for Postpartum Hypertension (ACE)
Primary Purpose
Hypertension in Pregnancy, Postpartum Preeclampsia
Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
ACE Inhibitors and Diuretics
NIFEdipine ER
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension in Pregnancy
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
Sites / Locations
- University of Texas Health Science Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Hctz/Lisinopril
Extended release nifedipine
Arm Description
Hctz/Lisinopril for postpartum management of hypertension. either a combined pill of ACE inhibitors and diuretics (Hydrochlorothiazide/Lisinopril)
calcium channel blocker (Nifedipine
Outcomes
Primary Outcome Measures
Number of Participants With Stage 2 Hypertension
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 Outcome Measures
Number of Participants With Severe Postpartum Hypertension
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
number of participants who received additional antihypertensive during admission, at 7-10 days postpartum.
Postpartum Length of Stay
time spent in hospital following delivery
Postpartum Readmission
occurrence of returning to hospital for admission postpartum
Time to Blood Pressure Control
The time from delivery to Blood Pressure control (i.e time from delivery to last BP <150/100).
Incidence of Persistent Postpartum Hypertension
Incidence of persistent postpartum hypertension 6 weeks postpartum (SBP ≥ 140 and/or DBP ≥ 90 mmHg).
Occurrence of Proteinuria
Proteinuria is measured by urine protein creatinine ratio
Presense of Labs Abnormality
Labs abnormality including hyperkalemia or creatinine increase
Compliance With Medications
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
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
Percentage of patients receiving primary care with BP measurement at 1 year
Postpartum Complications- Number of Participants With ICU Admission
Need for ICU admission
Postpartum Complications- Number of Participants With HELLP (Hemolysis, Elevated Liver Enzymes and Low Platelets) Syndrome
Hemolysis, elevated liver enzymes, low platelet count: HELLP
Postpartum Complications- Number of Participants With Eclampsia
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
Stroke
Postpartum Complications- Number of Participants With Renal Failure
Renal failure
Postpartum Complications- Number of Participants With Pulmonary Edema
Pulmonary edema
Postpartum Complications - Number of Participants With Cardiomyopathy
Cardiomyopathy
Postpartum Complications- Number of Participants With Maternal Death
Maternal death
Receipt of Additional Antihypertensive During Admission
Receipt of additional antihypertensive during admission at 6 weeks postpartum
Full Information
NCT ID
NCT05049616
First Posted
August 31, 2021
Last Updated
July 20, 2023
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT05049616
Brief Title
Oral Combined Hydrochlorothiazide/Lisinopril Versus Oral Nifedipine for Postpartum Hypertension
Acronym
ACE
Official Title
Oral Combined Hydrochlorothiazide/Lisinopril Versus Oral Nifedipine for Postpartum Hypertension: A Comparative Effectiveness Pilot Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 18, 2021 (Actual)
Primary Completion Date
June 26, 2022 (Actual)
Study Completion Date
October 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension in Pregnancy, Postpartum Preeclampsia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
randomized control trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hctz/Lisinopril
Arm Type
Experimental
Arm Description
Hctz/Lisinopril for postpartum management of hypertension. either a combined pill of ACE inhibitors and diuretics (Hydrochlorothiazide/Lisinopril)
Arm Title
Extended release nifedipine
Arm Type
Active Comparator
Arm Description
calcium channel blocker (Nifedipine
Intervention Type
Drug
Intervention Name(s)
ACE Inhibitors and Diuretics
Intervention Description
Hctz/Lisinopril (brand name: Zestoretic)
Intervention Type
Drug
Intervention Name(s)
NIFEdipine ER
Intervention Description
Extended release nifedipine
Primary Outcome Measure Information:
Title
Number of Participants With Stage 2 Hypertension
Description
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.
Time Frame
7-10 after delivery
Secondary Outcome Measure Information:
Title
Number of Participants With Severe Postpartum Hypertension
Description
severe postpartum hypertension (SBP≥160 and/or DBP≥110 mmHg on 2 occasions, 15 minutes apart)
Time Frame
7-10 after delivery
Title
Number of Participants Who Received Additional Antihypertensive During Admission
Description
number of participants who received additional antihypertensive during admission, at 7-10 days postpartum.
Time Frame
7-10 days postpartum
Title
Postpartum Length of Stay
Description
time spent in hospital following delivery
Time Frame
up to 30 days after delivery
Title
Postpartum Readmission
Description
occurrence of returning to hospital for admission postpartum
Time Frame
up to 30 days after delivery
Title
Time to Blood Pressure Control
Description
The time from delivery to Blood Pressure control (i.e time from delivery to last BP <150/100).
Time Frame
10 days
Title
Incidence of Persistent Postpartum Hypertension
Description
Incidence of persistent postpartum hypertension 6 weeks postpartum (SBP ≥ 140 and/or DBP ≥ 90 mmHg).
Time Frame
6 weeks postpartum
Title
Occurrence of Proteinuria
Description
Proteinuria is measured by urine protein creatinine ratio
Time Frame
7-10 days, and 6 weeks postpartum
Title
Presense of Labs Abnormality
Description
Labs abnormality including hyperkalemia or creatinine increase
Time Frame
7-10 days, and 6 weeks postpartum
Title
Compliance With Medications
Description
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 Frame
at the time of the 1st postpartum clinic visit, which is about 6 to 37 days after birth
Title
Time to Control Blood Pressure
Description
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
Time Frame
3 month-1 year
Title
Percentage of Patients Receiving Primary Care With BP Measurement
Description
Percentage of patients receiving primary care with BP measurement at 1 year
Time Frame
1 year postpartum
Title
Postpartum Complications- Number of Participants With ICU Admission
Description
Need for ICU admission
Time Frame
10 days postpartum
Title
Postpartum Complications- Number of Participants With HELLP (Hemolysis, Elevated Liver Enzymes and Low Platelets) Syndrome
Description
Hemolysis, elevated liver enzymes, low platelet count: HELLP
Time Frame
10 days postpartum
Title
Postpartum Complications- Number of Participants With Eclampsia
Description
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.
Time Frame
10 days postpartum
Title
Postpartum Complications- Number of Participants With Stroke
Description
Stroke
Time Frame
10 days postpartum
Title
Postpartum Complications- Number of Participants With Renal Failure
Description
Renal failure
Time Frame
10 days postpartum
Title
Postpartum Complications- Number of Participants With Pulmonary Edema
Description
Pulmonary edema
Time Frame
10 days postpartum
Title
Postpartum Complications - Number of Participants With Cardiomyopathy
Description
Cardiomyopathy
Time Frame
10 days postpartum
Title
Postpartum Complications- Number of Participants With Maternal Death
Description
Maternal death
Time Frame
10 days postpartum
Title
Receipt of Additional Antihypertensive During Admission
Description
Receipt of additional antihypertensive during admission at 6 weeks postpartum
Time Frame
6 weeks postpartum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michal Fishel Bartal, MD
Organizational Affiliation
UT Health Science Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Health Science Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Oral Combined Hydrochlorothiazide/Lisinopril Versus Oral Nifedipine for Postpartum Hypertension
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