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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05049616
Other study ID # HSC-MS-21-0476
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date October 18, 2021
Est. completion date October 1, 2023

Study information

Verified date July 2023
Source The University of Texas Health Science Center, Houston
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 70
Est. completion date October 1, 2023
Est. primary completion date June 26, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
United States University of Texas Health Science Center Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
7-10 after delivery
Secondary Number of Participants With Severe Postpartum Hypertension severe postpartum hypertension (SBP=160 and/or DBP=110 mmHg on 2 occasions, 15 minutes apart) 7-10 after delivery
Secondary Number of Participants Who Received Additional Antihypertensive During Admission number of participants who received additional antihypertensive during admission, at 7-10 days postpartum. 7-10 days postpartum
Secondary Postpartum Length of Stay time spent in hospital following delivery up to 30 days after delivery
Secondary Postpartum Readmission occurrence of returning to hospital for admission postpartum up to 30 days after delivery
Secondary Time to Blood Pressure Control The time from delivery to Blood Pressure control (i.e time from delivery to last BP <150/100). 10 days
Secondary Incidence of Persistent Postpartum Hypertension Incidence of persistent postpartum hypertension 6 weeks postpartum (SBP = 140 and/or DBP = 90 mmHg). 6 weeks postpartum
Secondary Occurrence of Proteinuria Proteinuria is measured by urine protein creatinine ratio 7-10 days, and 6 weeks postpartum
Secondary Presense of Labs Abnormality Labs abnormality including hyperkalemia or creatinine increase 7-10 days, and 6 weeks postpartum
Secondary 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. at the time of the 1st postpartum clinic visit, which is about 6 to 37 days after birth
Secondary 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 3 month-1 year
Secondary Percentage of Patients Receiving Primary Care With BP Measurement Percentage of patients receiving primary care with BP measurement at 1 year 1 year postpartum
Secondary Postpartum Complications- Number of Participants With ICU Admission Need for ICU admission 10 days postpartum
Secondary Postpartum Complications- Number of Participants With HELLP (Hemolysis, Elevated Liver Enzymes and Low Platelets) Syndrome Hemolysis, elevated liver enzymes, low platelet count: HELLP 10 days postpartum
Secondary 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. 10 days postpartum
Secondary Postpartum Complications- Number of Participants With Stroke Stroke 10 days postpartum
Secondary Postpartum Complications- Number of Participants With Renal Failure Renal failure 10 days postpartum
Secondary Postpartum Complications- Number of Participants With Pulmonary Edema Pulmonary edema 10 days postpartum
Secondary Postpartum Complications - Number of Participants With Cardiomyopathy Cardiomyopathy 10 days postpartum
Secondary Postpartum Complications- Number of Participants With Maternal Death Maternal death 10 days postpartum
Secondary Receipt of Additional Antihypertensive During Admission Receipt of additional antihypertensive during admission at 6 weeks postpartum 6 weeks postpartum
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