Clinical trial NCT05687344: Intensive Postpartum Antihypertensive Treatment
Official title: Intensive Postpartum Antihypertensive Treatment to Improve Women's Cardiovascular Health (IPAT Study)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Hypertensive Disorder of Pregnancy
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2023-01-18
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Feasibility in randomization
timeFrame: 12 months postpartum
measure: Feasibility in recruitment
timeFrame: 12 months postpartum
measure: Feasibility in retention
timeFrame: 12 months postpartum
measure: Contamination
timeFrame: 12 months postpartum
Secondary outcomes:
measure: New stage I hypertension
timeFrame: 12 months postpartum
measure: Life's Essential 8 cardiovascular health score (range 0-100)
timeFrame: 12 months postpartum
measure: Life's Simple 7 CVH (range 0-14)
timeFrame: 12 months postpartum
measure: Flow-mediated dilation
timeFrame: 12 months postpartum
measure: Serum biomarkers of CVD risk
timeFrame: 12 months postpartum
measure: arterial stiffness
timeFrame: 12 months postpartum
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Froedtert Hospital
state: Wisconsin
Study officials:
References: