Froedtert Hospital
Milwaukee, Wisconsin, 53226, United States
NCT Number: NCT05687344
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.
This study is active but is not currently recruiting participants.
18 year–45 year
Female
Interventional
Phase 3
Milwaukee, Wisconsin, 53226, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Postpartum BP treatment to <140/90 mmHg
Other names: Tight BP control group
Time frame: 12 months postpartum
Proportion of patients who enroll out of all approached, eligible patients.
Time frame: 12 months postpartum
Number of patients successfully enrolled per month during the study.
Time frame: 12 months postpartum
Proportion of enrolled patients who complete all study visits during the 12 months follow-up.
Time frame: 12 months postpartum
Percent of patients following other antihypertensive treatment regimens.
Time frame: 12 months postpartum
BP of ≥130/80 mmHg
Time frame: 12 months postpartum
The score will be calculated using American Heart Association application
Time frame: 12 months postpartum
Same metrics as LE8 excluding sleep
Time frame: 12 months postpartum
Brachial artery flow-mediated dilation will assess endothelial dysfunction.
Time frame: 12 months postpartum
Anti-angiogenic marker: Soluble fms-like tyrosine kinase (sFlt-1)
Time frame: 12 months postpartum
Carotid-femoral pulse wave velocity will assess arterial stiffness
Medical College of Wisconsin
Other
Intensive Postpartum Antihypertensive Treatment to Improve Women's Cardiovascular Health (IPAT Study)
Acronym: IPAT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05655936
Body Weight, Cardiovascular Diseases
Pittsburgh, Pennsylvania, United States
View Trial DetailsNCT06362356
Hypertensive Disorder of Pregnancy, Infections
Cleveland, Ohio, United States
View Trial DetailsNCT06194643
Hypertensive Disorder of Pregnancy, Infections
New York, United States
View Trial DetailsNCT05659173
Avitaminosis, Deficiency Diseases
Serdang, Selangor, Malaysia
View Trial Details