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The ACHIEVE Trial: Achieving longer gestation in preeclampsia via antihypertensive therapy.

Award Number: K23HL159331
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP
PERIOD OF PERFORMANCE START DATE: 07/15/2022
PERIOD OF PERFORMANCE END DATE: 06/30/2027

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The ACHIEVE Trial: Achieving longer gestation in preeclampsia via antihypertensive therapy. - ABSTRACT Dr. Rachel G. Sinkey is a maternal-fetal medicine subspecialist who seeks to become an independently funded clinician-scientist focused on hypertension and cardiovascular (CVD) disease in pregnancy and the postpartum period. She seeks a K23 Mentored Research Award to realize this goal and has assembled a team of world- renowned experts to provide mentorship as she completes a tailored, five-year career development and mentored research plan. In the comprehensive career development plan the candidate will: 1) obtain skills to independently design and conduct clinical trials; 2) complete a Master of Science in Public Health degree; 3) attain contemporary hypertension knowledge, and 4) obtain career skills in strategic grant planning and writing. The customized career development plan will be accompanied by a mentored randomized clinical trial focused on preeclampsia. Preeclampsia (PE) is a hypertensive disorder that occurs in the second half of pregnancy, complicating up to one in twelve pregnancies. Delivery immediately following PE diagnosis carries the least maternal risk; however, when possible, delivery is delayed if the gestation is preterm (<37 weeks) to decrease major effects of prematurity. Despite this, maternal or fetal health factors may lead to delivery of a preterm patient with PE including: 1) maternal end-organ damage or uncontrolled severe hypertension (known as severe PE), and 2) fetal abnormalities (involving amniotic fluid, fetal testing and/or uterine artery Dopplers). The American College of Cardiology/American Heart Association Hypertension Guideline defers pregnancy hypertension management to the American College of Obstetricians and Gynecologists (ACOG). ACOG recommends antihypertensive treatment for severe hypertension (BP ≥160/110 mmHg), to avoid acute cardiovascular complications. On the other hand, treatment of non-severe hypertension in women with PE is controversial, due to concerns that lowering arterial perfusion to the fetus may lead to impaired fetal growth. There is also concern that anti-hypertensive therapy may mask severe PE, leading to maternal harm. Evidence supporting these concerns is limited, and it is unknown whether antihypertensive treatment safely prolongs pregnancy, a prerequisite for neonatal benefit. Given these critical gaps in knowledge, we propose “The ACHIEVE Trial”, a phase II, open-label RCT (N=132) of antihypertensive treatment in preterm patients with non-severe PE. Participants will be randomized 1:1 to: 1) intervention – anti-hypertensive therapy for BP goal <140/90 mmHg, or 2) usual care – antihypertensive therapy only if BP ≥160/110 mmHg. In Aim 1 we will determine if treatment to achieve a BP goal <140/90 mmHg prolongs mean time to delivery. In Aim 2 we will examine whether the intervention reduces perinatal and maternal morbidity. We will also collect and store blood for future studies investigating CVD biomarkers and endothelial dysfunction. This research study, accompanied by a comprehensive career development plan, will provide a strong foundation for a productive independent career in clinical research focused on hypertension and cardiovascular disease in pregnancy and the postpartum period.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $191,376 )
2025	2025	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH STREET	BIRMINGHAM	AL	35294	JEFFERSON	USA	Cardiovascular Diseases Research	001	4	5/30/2025	NON-COMPETING CONTINUATION	$191,376
2025	2024	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH STREET	BIRMINGHAM	AL	35294	JEFFERSON	USA	Cardiovascular Diseases Research	000	3	3/26/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $191,376

Issue Date FY: 2024 ( Subtotal = $191,376 )
2024	2024	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH STREET	BIRMINGHAM	AL	35294	JEFFERSON	USA	Cardiovascular Diseases Research	000	3	7/4/2024	NON-COMPETING CONTINUATION	$191,376
														Subtotal = $191,376

Issue Date FY: 2023 ( Subtotal = $191,376 )
2023	2023	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Cardiovascular Diseases Research	000	2	7/24/2023	NON-COMPETING CONTINUATION	$191,376
														Subtotal = $191,376

Issue Date FY: 2022 ( Subtotal = $191,376 )
2022	2022	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Cardiovascular Diseases Research	000	1	7/15/2022	NEW	$191,376
														Subtotal = $191,376

Grand Total All Awards = $765,504

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The ACHIEVE Trial: Achieving longer gestation in preeclampsia via antihypertensive therapy.

Award Number: K23HL159331

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP

PERIOD OF PERFORMANCE START DATE: 07/15/2022

PERIOD OF PERFORMANCE END DATE: 06/30/2027

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