Intensive Postpartum Antihypertensive Treatment to Improve Women's Cardiovascular Health (IPAT Study)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Feasibility in recruitment
研究概览
简要总结
The long-term goal of our work is to evaluate the effect of intensive postpartum blood pressure control on maternal cardiovascular health, risk of chronic hypertension, and reversal of vascular dysfunction generated by hypertensive disorders of pregnancy, thus attenuating the lifelong trajectory of cardiovascular disease risk.
详细描述
The IPAT will randomize 60 postpartum patients with HDP at the Medical College of Wisconsin (MCW) to intensive BP control with Nifedipine extended release (ER) (target BP <140/90 mmHg) versus usual care (target BP <150/100 mmHg). Oversampling of Black patients with HDP will be done to ensure they comprise 50% of study participants. Patients enrolled in both arms will undergo education on healthy lifestyle following AHA "Life's Essential 8" (LE8) of tobacco cessation, physical activity, healthy sleep, and healthy diet with detailed overview of DASH throughout the first year postpartum with monthly virtual educational session delivered by a registered dietician and a life coach. Assessment of LE8 CVH score will be done after delivery, 6 weeks postpartum, and 12 months postpartum. Participants will also undergo vascular function assessment: endothelial dysfunction with brachial artery flow mediated dilation (FMD), arterial stiffness with carotid-femoral pulse wave velocity (cfPWV) and anti-angiogenic and inflammatory CVD biomarker with soluble fms-like tyrosine kinase (sFlt-1), at baseline, 6 weeks, and 12 months postpartum. The primary outcome is feasibility of all study procedures, including recruitment, retention, and adherence. Secondary outcomes are change in BP, CVH score, FMD, PWV, and sFlt-1 from baseline to 12 months postpartum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •HDP diagnosis (gestational hypertension or preeclampsia) according to ACOG guidelines
- •Postpartum day 0-3 and prior to discharge
- •Able to communicate in English or in Spanish
- •Age 18 - 45
排除标准
- •Pre-gestational hypertension
- •Pre-gestational diabetes ( type 1 or type 2)
- •Intent to transfer postpartum to an outside institution of the participating centers
- •Known allergy to nifedipine or other significant contraindication to nifedipine
- •Inability or unwillingness to provide informed consent
研究组 & 干预措施
Active control arm
Active control group - a group of usual care that follows ACOG recommendations with Nifedipine initiation at SBP≥150 mmHg or DBP≥100 mm Hg and maintaining BP at <150/100 mmHg during the first 6 weeks postpartum. In addition, participants will receive education on healthy lifestyle following AHA LE8.
干预措施: Nifedipine ER (Drug)
Intervention arm
Intervention group - intensive postpartum BP control with Nifedipine initiation at SBP≥140 mmHg or DBP≥90 mmHg and maintaining BP at <140/90 mmHg during the first 6 weeks postpartum. In addition, participants will receive education on healthy lifestyle following AHA LE8.
干预措施: Nifedipine ER (Drug)
结局指标
主要结局
Feasibility in recruitment
时间窗: 12 months postpartum
Number of patients successfully enrolled per month during the study.
Feasibility in retention
时间窗: 12 months postpartum
Proportion of enrolled patients who complete all study visits during the 12 months follow-up.
Feasibility in randomization
时间窗: 12 months postpartum
Proportion of patients who enroll out of all approached, eligible patients.
Contamination
时间窗: 12 months postpartum
Percent of patients following other antihypertensive treatment regimens.
次要结局
- Flow-mediated dilation(12 months postpartum)
- New stage I hypertension(12 months postpartum)
- Life's Essential 8 cardiovascular health score (range 0-100)(12 months postpartum)
- Life's Simple 7 CVH (range 0-14)(12 months postpartum)
- arterial stiffness(12 months postpartum)
- Serum biomarkers of CVD risk(12 months postpartum)
研究者
Anna Palatnik, MD
Associate Professor
Medical College of Wisconsin