A Randomized, Placebo-controlled Trial of DAPAgliflozin for Cardiovascular Risk Reduction in the Postpartum Period of Hypertensive Pregnancies
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Cardiovascular risk reduction score
研究概览
简要总结
This trial is a pilot-scale, single institution randomized, placebo-controlled trial to assess the feasibility, acceptability, and efficacy of administering dapagliflozin for cardiovascular risk reduction in the postpartum period. The target population is patients at high risk of adverse cardiovascular outcomes within five years post-delivery.
Eligible participants will be randomized to receive either: 1) dapagliflozin (10mg daily) for six months (DAPA group) or 2) an orally administered, daily placebo (Control group).
The study hypothesizes:
The dapagliflozin group will have higher cardiovascular risk reduction scores than the Control Group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants, the clinical team, and researchers will be blinded to group assignment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Admitted for delivery at the University of Michigan (UM) Labor and Delivery (L&D) unit or enrolled in the UM postpartum blood pressure monitoring program following a delivery at the UM L&D unit
- •Determined to be at least 23 and 0/7 weeks of gestation based on a clinically acceptable dating method (can be a single or multifetal gestation with or without the presence of fetal anomalies) at the time of delivery
- •Consents to participation and must understand/read/speak English with the ability to understand and willingness to sign a written informed consent in English
- •Diagnosed with a hypertensive pregnancy by either of the following criteria:
- •Taking an antihypertensive medication for the diagnosis of chronic or essential hypertension at the time of admission
- •Hypertension, chronic hypertension, or essential hypertension must be present in the prospective participant's medical record
- •Antihypertensive" can be any medication taken for the purpose of blood pressure control per the medical record
- •A documented hypertensive disorder of pregnancy (gestational hypertension, preeclampsia without severe features, preeclampsia with severe features, superimposed preeclampsia, or eclampsia) prior to delivery
- •Eligible participants must report a planned contraceptive method as part of the consent process, to be noted on their consent document.
- •Has two or more blood pressures ≥160/110 Millimeters of mercury (mmHg) at least 60 minutes apart
- •If an admitted patient does not meet this blood pressure criterion but is otherwise eligible, participants can consent to have a BNP drawn within 12 hours of delivery as an alternative measure of cardiovascular risk (if the brain natriuretic peptide (BNP) is ≥100 Picograms per milliliter (pg/ml), participants are eligible to participate)
排除标准
- •Non-English speaking
- •Ongoing pregnancy
- •Stated desire to become pregnant within 8 months post-delivery
- •Intention to breastfeed after enrollment
- •BNP ≥1000 pg/ml within 12 hours of delivery, clinical team to be notified of result
- •Comorbidities that may affect cardiovascular risk assessment (per protocol)
- •Contraindication to dapagliflozin (per protocol)
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Dapagliflozin
10 Milligram (mg) orally
干预措施: Dapagliflozin 10mg Tab (Drug)
结局指标
主要结局
Cardiovascular risk reduction score
时间窗: Baseline, 6 months
The score will be summed and compared between groups.The components with outcome-based binary assessments by the following: * Biometric: change in systolic blood pressure (scores of 0 or 1) and change in body weight (scores of 0 or 1) * Echocardiogram: change in left ventricle wall thickness (scores of 0 or 1) and change in left ventricle mass (scores of 0 or 1) * Clinical: Non-hospitalization (scores of 0 or 1) and return to baseline antihypertensive needs (scores of 0 or 1) The total scores range from 0-6 with a higher score indicating greater cardiovascular risk reduction.
次要结局
- Patient-stated adherence(baseline to 6 months)
- The number of patients screened(2-year recruitment period)
- The number of patients screen-outs vs screen-ins(2-year recruitment period)
- Reasons for ineligibility and refusal to participate(2-year recruitment period)
- Patient reported barriers to adherence(baseline to 6 months)
- Loss to follow-up rates(Baseline to 6 months)
研究者
Ashley Hesson
Assistant Professor of Obstetrics and Gynecology
University of Michigan