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Antihypertensive

Antihypertensive Therapy for Preeclampsia (Achieve Trial)

N/A
Recruiting
Led By Rachel Sinkey, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Hypertensive disorder of pregnancy including gestational hypertension or non-severe preeclampsia at enrollment
Pregnant women with gestational age between 23 weeks, 0 days and 35 weeks, 6 days
Must not have
Contraindications to labetalol and nifedipine XL
New-onset headache or visual disturbances unresponsive to medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to 6 weeks after delivery, up to 20 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if lowering BP in pregnant women with preeclampsia can help them carry their baby longer.

Who is the study for?
The ACHIEVE Trial is for pregnant women with high blood pressure disorders, including gestational hypertension or non-severe preeclampsia. Eligible participants are those between 23 and 35+6 weeks of pregnancy, expecting a single baby or twins, without severe preeclampsia or other complications that require immediate delivery.
What is being tested?
This trial tests if lowering blood pressure below 140/90 mmHg in pregnant women with hypertension can extend the duration of their pregnancy. It's a randomized study where some will receive antihypertensive treatment to achieve this target.
What are the potential side effects?
Antihypertensive treatments like labetalol and nifedipine XL may cause side effects such as dizziness, fatigue, headache, swollen ankles or feet (edema), and possible changes in heart rate.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have high blood pressure or mild preeclampsia during my pregnancy.
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I am pregnant and between 23 to 35 weeks along.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot take labetalol or nifedipine XL due to adverse reactions.
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I have new headaches or vision problems that medication doesn't help.
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I have kidney problems or high blood pressure.
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My kidney function is impaired with high creatinine levels.
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I am unable or unwilling to follow treatment recommendations.
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I have a known significant genetic or chromosomal abnormality.
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I have fluid in my lungs.
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I have severe pain in my upper abdomen or issues with liver function that are not explained.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to 6 weeks after delivery, up to 20 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to 6 weeks after delivery, up to 20 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean number of days from randomization to delivery
Secondary study objectives
Maternal healthcare utilization
Maternal morbidity
Neonatal healthcare utilization
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Antihypertensive treatment for a BP goal of less than 140/90 mmHg
Group II: Usual CareActive Control1 Intervention
Antihypertensive treatment only if BP ≥ 160/110 mmHg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Antihypertensive treatment
2012
Completed Phase 4
~400

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,646 Previous Clinical Trials
2,342,252 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,935 Previous Clinical Trials
47,792,199 Total Patients Enrolled
Rachel Sinkey, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
2 Previous Clinical Trials
440 Total Patients Enrolled

Media Library

Antihypertensive treatment (Antihypertensive) Clinical Trial Eligibility Overview. Trial Name: NCT05676476 — N/A
Prophylaxis of Preeclampsia Research Study Groups: Intervention, Usual Care
Prophylaxis of Preeclampsia Clinical Trial 2023: Antihypertensive treatment Highlights & Side Effects. Trial Name: NCT05676476 — N/A
Antihypertensive treatment (Antihypertensive) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05676476 — N/A
~70 spots leftby Dec 2026
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