What side effects are associated with this type of intervention?

Common treatments for high blood pressure include ACE inhibitors, ARBs, calcium channel blockers, thiazide diuretics, and beta-blockers. ACE inhibitors can cause cough, elevated blood potassium levels, and angioedema. ARBs may lead to dizziness, hyperkalemia, and renal impairment. Calcium channel blockers are associated with peripheral edema, constipation, and dizziness. Thiazide diuretics can cause electrolyte imbalances, such as hyponatremia and hypokalemia, as well as gout. Beta-blockers may result in fatigue, bradycardia, and worsening of asthma symptoms.

What prior FDA approvals exist?

The FDA has approved several classes of drugs for the treatment of high blood pressure, including calcium channel blockers (CCBs) such as amlodipine and verapamil, angiotensin-converting enzyme (ACE) inhibitors like benazepril and quinapril, angiotensin receptor blockers (ARBs) such as losartan, and thiazide diuretics like hydrochlorothiazide. These medications have been shown to be effective in lowering blood pressure and reducing the risk of cardiovascular events. Combination therapies, such as benazepril plus amlodipine, have also been approved to enhance efficacy and minimize side effects.

What other types of research exist?

Promising novel alternatives for antihypertensive treatment in 2024 include: 1) Newer antihypertensive agents with improved efficacy and fewer side effects, such as angiotensin receptor-neprilysin inhibitors (ARNIs). 2) Combination therapies that include drugs like ACE inhibitors or ARBs with calcium channel blockers or diuretics. 3) Personalized medicine approaches that tailor treatment based on genetic and biomarker profiles. 4) Non-pharmacological interventions like renal denervation and baroreceptor activation therapy, which have shown potential in treatment-resistant hypertension.

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Beta Blocker

Blood Pressure Medication for Early Pregnancy Hypertension

Phase 2

Recruiting

Research Sponsored by Marshall University

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Must not have

Patients with end stage renal disease

Patients with the diagnosis of chronic hypertension

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether treating high blood pressure in early pregnancy with specific medications (nifedipine or labetalol) improves health outcomes for mothers and babies. The study focuses on pregnant women with elevated blood pressure. These medications work by relaxing blood vessels or slowing the heart rate to lower blood pressure. Nifedipine and labetalol are commonly used medications for high blood pressure in pregnancy, with studies showing their effectiveness in managing hypertensive disorders of pregnancy.

Who is the study for?

This trial is for pregnant individuals between 12 and 16 weeks gestation, under care at Marshall University offices, with slightly elevated blood pressure (systolic 120-139 or diastolic 80-89). It's not for those already on hypertension medication, with chronic hypertension, substance use disorders, alcohol consumption during pregnancy, diabetes or end stage renal disease.

What is being tested?

The study compares the effects of treating early pregnancy high blood pressure with either Labetalol or Nifedipine versus no treatment. Participants will be randomly assigned to one of these three groups after giving their consent.

What are the potential side effects?

Labetalol may cause fatigue, headache, dizziness or nausea. Nifedipine can lead to swelling in the legs and feet, flushing, heart palpitations and may occasionally lower your blood pressure too much.

Eligibility Criteria

Exclusion Criteria

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

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My kidneys are in the final stage of failure.

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I have been diagnosed with chronic high blood pressure.

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My blood pressure is 140/90 or higher, indicating chronic hypertension.

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I am currently taking medication for high blood pressure.

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I have Type I or Type II Diabetes Mellitus.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Treatment of elevated blood pressures

Secondary study objectives

ICG directed treatment

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Treatment GroupActive Control2 Interventions

Treatment of elevated blood pressures (120 or greater systolic OR 80 or greater diastolic)

Group II: Non-treatment GroupActive Control1 Intervention

Non-treatment of blood pressures between 120-139 systolic and 80-89 diastolic

0 / 5Eligibility 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

Common treatments for high blood pressure include ACE inhibitors, ARBs, calcium channel blockers, and diuretics. ACE inhibitors and ARBs work by relaxing blood vessels through the inhibition of angiotensin-converting enzyme and blocking angiotensin II receptors, respectively, which reduces blood pressure. Calcium channel blockers prevent calcium from entering the heart and blood vessel walls, leading to relaxed vessels and lower blood pressure. Diuretics help the kidneys remove excess sodium and water from the body, decreasing blood volume and pressure. These mechanisms are crucial for high blood pressure patients as they help prevent complications such as stroke, heart attack, and kidney damage by effectively lowering and managing blood pressure levels.

Implications of the links between hypertension and myocardial infarction for choice of drug therapy in patients with hypertension.Prehypertension: the rationale for early drug therapy.Recent hypertension trials: implications and controversies.