What side effects are associated with this type of intervention?

Common treatments for hypertension, such as Hydrochlorothiazide, a thiazide diuretic, can cause side effects like electrolyte imbalances (e.g., low potassium, low sodium, high uric acid), which may lead to conditions like gout. Other antihypertensive medications include ACE inhibitors and ARBs, which can cause high potassium levels and, rarely, angioedema, and calcium channel blockers, which may lead to peripheral edema and constipation. These side effects are generally mild and infrequent but should be monitored by a healthcare provider.

What prior FDA approvals exist?

Hydrochlorothiazide, a thiazide-type diuretic, has been widely used and FDA-approved for the treatment of hypertension by reducing blood pressure through the removal of excess fluid and salt. Other thiazide-like diuretics such as chlorthalidone and indapamide have also been approved and are preferred due to their potency and cardiovascular benefits. Additionally, angiotensin-converting enzyme (ACE) inhibitors like enalapril and lisinopril, and angiotensin receptor blockers (ARBs) such as losartan and valsartan, have received FDA approval for hypertension management. Calcium channel blockers, including amlodipine, are also commonly approved and used in combination therapies.

What other types of research exist?

Promising novel alternatives to Hydrochlorothiazide for hypertension treatment include: 1) Angiotensin II receptor blockers (ARBs) such as losartan and valsartan, which are effective in reducing blood pressure with a favorable side effect profile. 2) Neutral endopeptidase inhibitors, which are under development and show potential in clinical studies. 3) Carvedilol, a multiple action antihypertensive agent, which has shown efficacy in both clinical and experimental studies. 4) Dihydropyridine calcium channel blockers like amlodipine, which are recommended for patients who do not achieve sufficient blood pressure control with other agents. These alternatives offer different mechanisms of action and may be suitable based on individual patient profiles.

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Diuretic

Hydrochlorothiazide for Postpartum Hypertension

Phase 3

Recruiting

Led By Antonio Saad, M.D.

Research Sponsored by The University of Texas Medical Branch, Galveston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Maternal age ≥ 18 years and <50 years

Diagnosis of gestational hypertension or preeclampsia at any time during pregnancy, labor or postpartum (defined as isolated systolic BP of 140 mm Hg or greater, a diastolic BP of 90 mm Hg or greater, or both; or defined as new-onset hypertension plus new-onset proteinuria, or in the absence of proteinuria, preeclampsia is diagnosed as hypertension in association with thrombocytopenia (platelet count less than 100,000/microliter), impaired liver function (elevated blood levels of liver transaminases to twice the normal concentration), the new development of renal insufficiency (elevated serum creatinine greater than 1.1 mg/dL or a doubling of serum creatinine in the absence of other renal disease), pulmonary edema, or new-onset cerebral or visual disturbances)

Must not have

Pre-gestational diabetes

Subject requiring antihypertensive therapy at time of screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-6 weeks postpartum

Awards & highlights

Pivotal Trial

Summary

This trial is testing whether hydrochlorothiazide can help prevent or reduce high blood pressure in women who have given birth. The medication works by making you urinate more, which helps lower blood pressure. Hydrochlorothiazide is known for its effectiveness in lowering blood pressure.

Who is the study for?

This trial is for women aged 18-50 who had high blood pressure or preeclampsia during pregnancy. They must not need blood pressure meds at screening, can't be discharged with such meds, and shouldn't have kidney failure, sulfonamide allergy, pre-gestational diabetes, lactose intolerance or issues that prevent follow-up.

What is being tested?

The study tests if Hydrochlorothiazide (HCTZ), a water pill, can prevent high blood pressure problems after birth compared to a placebo. Women will randomly receive either HCTZ or an inactive tablet to see which is better at preventing relapses of hypertension or preeclampsia postpartum.

What are the potential side effects?

Hydrochlorothiazide may cause dehydration, low potassium levels leading to muscle weakness and abnormal heart rhythms, light sensitivity resulting in sunburns more easily than usual, dizziness upon standing up too fast due to lowered blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman aged 18 to 49.

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I have been diagnosed with high blood pressure or preeclampsia during or after pregnancy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had diabetes before becoming pregnant.

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I am on medication for high blood pressure.

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I will be discharged with a prescription for blood pressure pills.

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I cannot take hydrochlorothiazide due to severe kidney issues or an allergy to sulfonamides.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-6 weeks postpartum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-6 weeks postpartum

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-6 weeks postpartum for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Need for additional antihypertensive therapy

Rate of readmission and/or triage visits

Secondary study objectives

Adverse Events

Elevation of blood pressure >150/90

Length of hospital stay

+3 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Hydrochlorothiazide 50mg TabletActive Control1 Intervention

Hydrochlorothiazide 50 mg per os once daily as soon as the subjects can tolerate sips of water after delivery and for a total of fourteen days postpartum.

Group II: Placebo TabletPlacebo Group1 Intervention

Placebo per os once daily as soon as the subjects can tolerate sips of water after delivery and for fourteen days postpartum

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for hypertension include ACE inhibitors, ARBs, calcium channel blockers, and thiazide diuretics. ACE inhibitors and ARBs work by relaxing blood vessels through the inhibition of angiotensin II, a hormone that causes vasoconstriction. Calcium channel blockers prevent calcium from entering the heart and blood vessel walls, leading to relaxed vessels and lower blood pressure. Thiazide diuretics, such as hydrochlorothiazide, reduce blood pressure by removing excess fluid and salt from the body, decreasing blood volume. These mechanisms are crucial for hypertension patients as they help to reduce the risk of cardiovascular events, such as heart attacks and strokes, by effectively managing high blood pressure.

Disposition and pharmacodynamics of diuretics and antihypertensive agents in renal disease.