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The ACHIEVE Trial: Achieving Longer Gestation in Preeclampsia Via Antihypertensive Therapy. (Achieve)

Primary Purpose

Preeclampsia, Gestational Hypertension, Hypertensive Disorder of Pregnancy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Antihypertensive treatment
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preeclampsia

Eligibility Criteria

14 Years - 49 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Pregnant women Gestational age: 23 weeks, 0 days to 35 weeks, 6 days Hypertensive disorder of pregnancy including gestational hypertension or preeclampsia, the non-severe form at enrollment, which is called without severe features by the American College of Obstetricians and Gynecologists. No evidence of the severe form of preeclampsia, termed severe features, as outlined in maternal exclusions No indication for delivery at the time of enrollment. Planned expectant management at time of enrollment Singleton or dichorionic twin gestation, defined at and beyond 14 weeks gestation. (A pregnancy complicated by a vanishing twin in the first trimester defined as less than 14 weeks gestation will be eligible.) Dating sonogram at less than 21 weeks of gestation Prenatal care, or another healthcare visit with a documented blood pressure, at less than 21 weeks gestation Intact membranes Exclusion Criteria: Preeclampsia with severe features, defined per ACOG as: Systolic blood pressure of 160 mm Hg or more, or diastolic blood pressure of 110 mm Hg or more on two occasions at least 4 hours apart (unless antihypertensive therapy is initiated before this time) Thrombocytopenia defined as: lower than 100 x 10e9 platelets/L Impaired liver function that is not accounted for by alternative diagnoses and as indicated by abnormally elevated blood concentrations of liver enzymes (to more than twice the upper limit normal concentrations), or by severe persistent right upper quadrant or epigastric pain unresponsive to medications Renal insufficiency (serum creatinine concentration more than 1.1 mg/dL or a doubling of the serum creatinine concentration in the absence of other renal disease) Pulmonary edema New-onset headache unresponsive to medication and not accounted for by alternative diagnoses Visual disturbances Underlying renal dysfunction defined as, presenting the following parameters prior to 20 weeks gestation: baseline creatinine, equal to or higher than, 1.2 mg/dL Or proteinuria: defined as presenting protein in urine, equal to or higher than, 300 mg/24 hours or protein/creatinine ratio, equal to or higher than, 0.3 or Urine dipstick reading of greater than or equal to 2 at baseline and in the absence of a urinary tract infection Stage 2 chronic hypertension Labetalol contraindications according to the FDA package insert, which are defined as follows: +Bronchial asthma, cardiac failure, greater-than-first-degree heart block, cardiogenic shock, severe bradycardia defined as heart rate lower than 60 beats per minute, other conditions associated with severe and prolonged hypotension, pheochromocytoma, patients with a history of hypersensitivity to any component of the product Patient unable to or unwilling to adhere to management recommendations Fetal Reasons for Study Ineligibility: Fetal growth restriction (lower than 10th percentile) at enrollment, based on an ultrasound within 3 weeks prior to enrollment Oligohydramnios defined by amniotic fluid deepest vertical pocket <2 cm based on an ultrasound within the 48 hours prior to enrollment Known major structural or chromosomal abnormality

Sites / Locations

  • University of Alabama at BirminghamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Usual Care

Arm Description

Antihypertensive treatment for a BP goal of less than 140/90 mmHg

Antihypertensive treatment only if BP ≥ 160/110 mmHg

Outcomes

Primary Outcome Measures

Mean number of days from randomization to delivery
Duration of prolongation of pregnancy

Secondary Outcome Measures

Perinatal morbidity
Composite of NICU admission ≥2 days, bronchopulmonary dysplasia, necrotizing enterocolitis, intraventricular hemorrhage, retinopathy of prematurity, or fetal or newborn death within 6 weeks after birth; individual elements of the composite, the frequency of small for gestational age neonates, birthweight.
Neonatal healthcare utilization
NICU and hospital length of stay
Maternal morbidity
Composite of severe hypertension, pulmonary edema, heart failure, eclampsia, stroke, liver dysfunction, acute renal failure, thrombocytopenia, abruption, ICU admission, postpartum hospital readmission for hypertension management, or death within 6 weeks of delivery; individual elements of the composite.
Maternal healthcare utilization
Antepartum and postpartum hospital length of stay, ICU admission, postpartum readmission.

Full Information

First Posted
January 3, 2023
Last Updated
June 29, 2023
Sponsor
University of Alabama at Birmingham
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT05676476
Brief Title
The ACHIEVE Trial: Achieving Longer Gestation in Preeclampsia Via Antihypertensive Therapy.
Acronym
Achieve
Official Title
The ACHIEVE Trial: Achieving Longer Gestation in Preeclampsia Via Antihypertensive Therapy.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 14, 2023 (Actual)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
June 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The Achieve Trial is a randomized clinical trial to test whether lowering blood pressure to less than 140/90 mmHg in women with hypertensive disorders of pregnancy will prolong pregnancy.
Detailed Description
Hypertensive disorders of pregnancy, including gestational hypertension and preeclampsia, are characterized by new onset high blood pressure in pregnancy and constitute a major cause of maternal and perinatal morbidity and mortality; severe hypertension (blood pressure ≥160/110 mmHg) is a common trigger for antihypertensive treatment and preterm delivery. We propose a clinical trial that will test whether lowering the blood pressure in women with hypertensive disorders of pregnancy at <36 weeks' gestation to <140/90 mmHg will prolong pregnancy and, therefore, improve maternal and fetal/neonatal outcomes. Data generated in this study, along with knowledge and skills acquired by the candidate in the complementary career development plan, will facilitate an independent research career focused on hypertension and cardiovascular disease in pregnancy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia, Gestational Hypertension, Hypertensive Disorder of Pregnancy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Antihypertensive treatment for a BP goal of less than 140/90 mmHg
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Antihypertensive treatment only if BP ≥ 160/110 mmHg
Intervention Type
Drug
Intervention Name(s)
Antihypertensive treatment
Intervention Description
Antihypertensive treatment to goal of less than 140/90 mmHg
Primary Outcome Measure Information:
Title
Mean number of days from randomization to delivery
Description
Duration of prolongation of pregnancy
Time Frame
From randomization to delivery, up to 14 weeks
Secondary Outcome Measure Information:
Title
Perinatal morbidity
Description
Composite of NICU admission ≥2 days, bronchopulmonary dysplasia, necrotizing enterocolitis, intraventricular hemorrhage, retinopathy of prematurity, or fetal or newborn death within 6 weeks after birth; individual elements of the composite, the frequency of small for gestational age neonates, birthweight.
Time Frame
6 weeks
Title
Neonatal healthcare utilization
Description
NICU and hospital length of stay
Time Frame
6 weeks
Title
Maternal morbidity
Description
Composite of severe hypertension, pulmonary edema, heart failure, eclampsia, stroke, liver dysfunction, acute renal failure, thrombocytopenia, abruption, ICU admission, postpartum hospital readmission for hypertension management, or death within 6 weeks of delivery; individual elements of the composite.
Time Frame
From randomization to 6 weeks after delivery, up to 20 weeks
Title
Maternal healthcare utilization
Description
Antepartum and postpartum hospital length of stay, ICU admission, postpartum readmission.
Time Frame
From randomization to 6 weeks after delivery, up to 20 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pregnant women Gestational age: 23 weeks, 0 days to 35 weeks, 6 days Hypertensive disorder of pregnancy including gestational hypertension or preeclampsia, the non-severe form at enrollment, which is called without severe features by the American College of Obstetricians and Gynecologists. No evidence of the severe form of preeclampsia, termed severe features, as outlined in maternal exclusions No indication for delivery at the time of enrollment. Planned expectant management at time of enrollment Singleton or dichorionic twin gestation, defined at and beyond 14 weeks gestation. (A pregnancy complicated by a vanishing twin in the first trimester defined as less than 14 weeks gestation will be eligible.) Dating sonogram at less than 21 weeks of gestation Prenatal care, or another healthcare visit with a documented blood pressure, at less than 21 weeks gestation Intact membranes Exclusion Criteria: Preeclampsia with severe features, defined per ACOG as: Systolic blood pressure of 160 mm Hg or more, or diastolic blood pressure of 110 mm Hg or more on two occasions at least 4 hours apart (unless antihypertensive therapy is initiated before this time) Thrombocytopenia defined as: lower than 100 x 10e9 platelets/L Impaired liver function that is not accounted for by alternative diagnoses and as indicated by abnormally elevated blood concentrations of liver enzymes (to more than twice the upper limit normal concentrations), or by severe persistent right upper quadrant or epigastric pain unresponsive to medications Renal insufficiency (serum creatinine concentration more than 1.1 mg/dL or a doubling of the serum creatinine concentration in the absence of other renal disease) Pulmonary edema New-onset headache unresponsive to medication and not accounted for by alternative diagnoses Visual disturbances Underlying renal dysfunction defined as, presenting the following parameters prior to 20 weeks gestation: baseline creatinine, equal to or higher than, 1.2 mg/dL Or proteinuria: defined as presenting protein in urine, equal to or higher than, 300 mg/24 hours or protein/creatinine ratio, equal to or higher than, 0.3 or Urine dipstick reading of greater than or equal to 2 at baseline and in the absence of a urinary tract infection Stage 2 chronic hypertension Labetalol contraindications according to the FDA package insert, which are defined as follows: +Bronchial asthma, cardiac failure, greater-than-first-degree heart block, cardiogenic shock, severe bradycardia defined as heart rate lower than 60 beats per minute, other conditions associated with severe and prolonged hypotension, pheochromocytoma, patients with a history of hypersensitivity to any component of the product Patient unable to or unwilling to adhere to management recommendations Fetal Reasons for Study Ineligibility: Fetal growth restriction (lower than 10th percentile) at enrollment, based on an ultrasound within 3 weeks prior to enrollment Oligohydramnios defined by amniotic fluid deepest vertical pocket <2 cm based on an ultrasound within the 48 hours prior to enrollment Known major structural or chromosomal abnormality
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rachel Sinkey, MD
Phone
205-934-5611
Email
rsinkey@uabmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Alan Tita, MD
Phone
205-934-5611
Email
atita@uabmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Sinkey, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Sinkey
Phone
205-934-5611
Email
rsinkey@uabmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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29384983
Citation
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32852691
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Sinkey RG, Battarbee AN, Bello NA, Ives CW, Oparil S, Tita ATN. Prevention, Diagnosis, and Management of Hypertensive Disorders of Pregnancy: a Comparison of International Guidelines. Curr Hypertens Rep. 2020 Aug 27;22(9):66. doi: 10.1007/s11906-020-01082-w.
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The ACHIEVE Trial: Achieving Longer Gestation in Preeclampsia Via Antihypertensive Therapy.

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