Oral Combined Hydrochlorothiazide/Lisinopril Versus Oral Nifedipine for Postpartum Hypertension

(ACE Trial)

Overseen By Sunbola Ashimi, PhD

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: The University of Texas Health Science Center, Houston

Must be taking: Blood pressure medications

Disqualifiers: Renal disease, Angioedema, Hyperkalemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 7-10 days

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a combined pill of two medications to help lower blood pressure in women who have high blood pressure after giving birth. The pill works by relaxing blood vessels and removing extra salt and water from the body. The goal is to see if this combined pill is more effective than the usual treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. However, since the study involves testing a new combination of blood pressure medications, you might need to adjust your current treatment. It's best to discuss this with the trial coordinators.

Is the treatment generally safe for humans?

Nifedipine and lisinopril have been studied for safety in humans, showing that both are generally safe for treating conditions like high blood pressure and angina. Some common side effects include headaches, flushing, and ankle swelling for nifedipine, while lisinopril may cause cough and dizziness. Serious adverse events are rare for both medications. ^{1 2 3 4 5}

How does the drug Hydrochlorothiazide/Lisinopril, Nifedipine ER differ from other hypertension treatments?

This drug combination is unique because it combines an ACE inhibitor (lisinopril) and a calcium channel blocker (nifedipine ER) with a diuretic (hydrochlorothiazide), which can provide a more comprehensive approach to lowering blood pressure by addressing different mechanisms. This combination may offer enhanced blood pressure control compared to using each component alone. ^{2 4 6 7 8}

What data supports the effectiveness of the drug Hydrochlorothiazide/Lisinopril, Nifedipine ER?

Research shows that nifedipine, when used with a diuretic, effectively lowers blood pressure in patients with hypertension (high blood pressure). However, adding a thiazide diuretic to patients already on nifedipine may not further reduce blood pressure, possibly due to nifedipine's effect on sodium balance. ^{9 10 11 12 13}

Who Is on the Research Team?

Michal Fishel Bartal, MD

Principal Investigator

UT Health Science Center

Are You a Good Fit for This Trial?

Inclusion Criteria

Chronic hypertension requiring blood pressure medication postpartum

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

Exclusion Criteria

Hyperkalemia (serum potassium >5 mEq/L) during current admission

Pulmonary edema

Urine output < 30 cc/h prior to screening for eligibility

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Hctz/Lisinopril or Nifedipine for postpartum management of hypertension

7-10 days

Initial postpartum visit

Follow-up

Participants are monitored for blood pressure control and postpartum complications

1 year

Regular follow-up visits, including telephone encounters

Extended Follow-up

Long-term monitoring of blood pressure and cardiovascular health

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Hydrochlorothiazide/Lisinopril
• Nifedipine ER

How Is the Trial Designed?

Group I: Hctz/Lisinopril Experimental Treatment 1 Intervention

Hctz/Lisinopril for postpartum management of hypertension. either a combined pill of ACE inhibitors and diuretics (Hydrochlorothiazide/Lisinopril)

Group II: Extended release nifedipine Active Control 1 Intervention

calcium channel blocker (Nifedipine

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Published Research Related to This Trial

In a study involving 3972 patients with mild to moderate essential hypertension, nifedipine demonstrated significant efficacy, with 66.5% of patients achieving a diastolic blood pressure of 90 mmHg or below after one month of treatment.

The safety profile of nifedipine showed expected side effects like flushing and headache, which decreased over time, while ankle edema persisted, indicating the need for monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of nifedipine 20 mg tablets in hypertension using electronic data collection in general practice. Marley, JE.[2022]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Nifedipine, diuretics and sodium balance. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Nifedipine in the treatment of essential hypertension. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Nifedipine, sodium intake, diuretics, and sodium balance. [2018]

4. Japan pubmed.ncbi.nlm.nih.gov

Hypotensive action of nifedipine (Ca2+-antagonist) and propranolol in acute trials and its long-term therapy of hypertensive coronary heart disease patients. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Effect of treatment with nimodipine in patients with mild and moderate essential hypertension. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Nifedipine therapy in angina pectoris: evaluation of safety and side effects. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the antihypertensive effect of lisinopril compared with nifedipine in patients with mild to severe essential hypertension. [2017]

8. England pubmed.ncbi.nlm.nih.gov

Post-marketing surveillance of lisinopril in general practice in the UK. [2016]

9. England pubmed.ncbi.nlm.nih.gov

ACE inhibition versus calcium antagonism in the treatment of mild to moderate hypertension: a multicentre study. Ireland-Netherlands Lisinopril-Nifedipine Study Group. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of nifedipine 20 mg tablets in hypertension using electronic data collection in general practice. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Double-blind, placebo-controlled trial of twice-daily nifedipine as a step-2 agent in mild essential hypertension. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Captopril and nifedipine interactions in the treatment of essential hypertensives: a crossover study. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Comparative efficacy and safety of nisoldipine extended-release (ER) and amlodipine (CESNA-III study) in African American patients with hypertension. [2022]