Hydrochlorothiazide/Lisinopril vs Nifedipine for 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two medications to determine which better controls high blood pressure in women who have just given birth. One treatment, Hydrochlorothiazide/Lisinopril, combines an ACE inhibitor, which relaxes veins and arteries, and a diuretic, which removes extra salt and water. The other, Nifedipine ER, is a calcium channel blocker that prevents calcium from entering heart and artery cells to lower blood pressure. The trial targets women diagnosed with high blood pressure after childbirth or who had a hypertensive disorder during pregnancy and require medication. As a Phase 4 trial, this research aims to understand how these FDA-approved treatments can benefit more patients.

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.

What is the safety track record for these treatments?

Research has shown that the combination pill Hydrochlorothiazide/Lisinopril is generally well-tolerated for managing blood pressure. It works effectively in the short term and is usually safe, though some people might experience side effects.

For Nifedipine ER, another blood pressure medication, studies have indicated its effectiveness and safety during pregnancy and after childbirth. It even reduces the risk of needing to return to the hospital for blood pressure issues after giving birth.

Both treatments have proven to control blood pressure safely. Their long-term use adds extra confidence in their safety. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the combination of Hydrochlorothiazide and Lisinopril for postpartum hypertension because it uniquely combines an ACE inhibitor with a diuretic in a single pill. This dual-action approach not only helps to relax blood vessels but also reduces excess water and salt in the body, potentially offering more comprehensive blood pressure control than standard treatments. On the other hand, Nifedipine ER, a calcium channel blocker, is a well-established option that works by relaxing the muscles of the heart and blood vessels. The combination of these treatments could provide doctors with more tailored options to manage postpartum hypertension effectively.

What evidence suggests that this trial's treatments could be effective for postpartum hypertension?

In this trial, participants will receive either Hydrochlorothiazide/Lisinopril or Nifedipine ER for postpartum hypertension management. Research has shown that Hydrochlorothiazide and Lisinopril together can effectively manage high blood pressure after childbirth. One study found that people using this combination had better blood pressure control than those taking Nifedipine. Specifically, 27% of those on the combination treatment reached the main goal of the study, compared to 43% of those on Nifedipine. However, Nifedipine remains a strong option; it has reduced the need for emergency blood pressure treatment during childbirth and lowered the chance of hospital readmission for blood pressure issues after delivery. Both treatments are effective, but the Hydrochlorothiazide/Lisinopril combination might offer better short-term control. ^{1 3 5 6 7}

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36787814/

a comparative-effectiveness pilot randomized controlled trial Conclusion: The results of the pilot trial suggest a high probability that combined hydrochlorothiazide and lisinopril therapy produces superior short-term BP ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05049616

Study Details | NCT05049616 | Oral Combined ... Hypothesis: that in postpartum women with hypertensive disorders, oral combined Hydrochlorothiazide/Lisinopril will reduce postpartum hypertension at 7 days ...

3. ajog.org ajog.org/article/S0002-9378(22)00908-5/fulltext

Oral combined hydrochlorothiazide/lisinopril versus ... The primary outcome occurred in 27% in the HCTZ/lisinopril group compared to 43% in the nifedipine group (posterior adjusted RR, 0.74, 95% credible interval, ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05049616?cond=%22Preeclampsia%2Feclampsia%201%22&intr=%22angiotensin-converting%20enzyme%20inhibitors%22&viewType=Table&rank=3&tab=results

Study Results | Oral Combined Hydrochlorothiazide ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05049616/oral-combined-hydrochlorothiazide-lisinopril-versus-oral-nifedipine-for-postpartum-hypertension

Oral Combined Hydrochlorothiazide/Lisinopril Versus ... The purpose of this study is to see if a combined pill of Angiotensin-converting enzyme (ACE) inhibitors (a medication that helps relax your ...

6. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.124.073302

Hypertension in Pregnancy and Postpartum Data from the United States highlight favorable outcomes for postpartum HBPM compared with usual care.

7. ajog.org ajog.org/article/S0002-9378(23)00023-6/abstract

Oral combined hydrochlorothiazide and lisinopril vs ... We evaluated whether combined oral hydrochlorothiazide and lisinopril therapy produced superior short-term blood pressure control when compared with nifedipine.