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Intensive Postpartum Antihypertensive Treatment (IPAT)

Primary Purpose

Hypertensive Disorder of Pregnancy

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
NIFEdipine ER
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertensive Disorder of Pregnancy

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Froedtert HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention arm

Active control arm

Arm Description

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.

Active control group - a group of usual care that follows ACOG recommendations2 with Nifedipine initiation at SBP≥160 mmHg or DBP≥110 mm Hg and maintaining BP at <160/110 mmHg during the first 6 weeks postpartum. In addition, participants will receive education on healthy lifestyle following AHA LE8.

Outcomes

Primary Outcome Measures

Feasibility in randomization
Proportion of patients who enroll out of all approached, eligible patients.
Feasibility in recruitment
Number of patients successfully enrolled per month during the study.
Feasibility in retention
Proportion of enrolled patients who complete all study visits during the 12 months follow-up.
Contamination
Percent of patients following other antihypertensive treatment regimens.

Secondary Outcome Measures

New stage I hypertension
BP of ≥130/80 mmHg
Life's Essential 8 cardiovascular health score (range 0-100)
The score will be calculated using American Heart Association application
Life's Simple 7 CVH (range 0-14)
Same metrics as LE8 excluding sleep
Flow-mediated dilation
Brachial artery flow-mediated dilation will assess endothelial dysfunction.
Serum biomarkers of CVD risk
Anti-angiogenic marker: Soluble fms-like tyrosine kinase (sFlt-1)
arterial stiffness
Carotid-femoral pulse wave velocity will assess arterial stiffness

Full Information

First Posted
January 1, 2023
Last Updated
October 21, 2023
Sponsor
Medical College of Wisconsin
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1. Study Identification

Unique Protocol Identification Number
NCT05687344
Brief Title
Intensive Postpartum Antihypertensive Treatment
Acronym
IPAT
Official Title
Intensive Postpartum Antihypertensive Treatment to Improve Women's Cardiovascular Health (IPAT Study)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
March 2026 (Anticipated)
Study Completion Date
March 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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 <160/110 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertensive Disorder of Pregnancy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Active control arm
Arm Type
Active Comparator
Arm Description
Active control group - a group of usual care that follows ACOG recommendations2 with Nifedipine initiation at SBP≥160 mmHg or DBP≥110 mm Hg and maintaining BP at <160/110 mmHg during the first 6 weeks postpartum. In addition, participants will receive education on healthy lifestyle following AHA LE8.
Intervention Type
Drug
Intervention Name(s)
NIFEdipine ER
Other Intervention Name(s)
Tight BP control group
Intervention Description
Postpartum BP treatment to <140/90 mmHg
Primary Outcome Measure Information:
Title
Feasibility in randomization
Description
Proportion of patients who enroll out of all approached, eligible patients.
Time Frame
12 months postpartum
Title
Feasibility in recruitment
Description
Number of patients successfully enrolled per month during the study.
Time Frame
12 months postpartum
Title
Feasibility in retention
Description
Proportion of enrolled patients who complete all study visits during the 12 months follow-up.
Time Frame
12 months postpartum
Title
Contamination
Description
Percent of patients following other antihypertensive treatment regimens.
Time Frame
12 months postpartum
Secondary Outcome Measure Information:
Title
New stage I hypertension
Description
BP of ≥130/80 mmHg
Time Frame
12 months postpartum
Title
Life's Essential 8 cardiovascular health score (range 0-100)
Description
The score will be calculated using American Heart Association application
Time Frame
12 months postpartum
Title
Life's Simple 7 CVH (range 0-14)
Description
Same metrics as LE8 excluding sleep
Time Frame
12 months postpartum
Title
Flow-mediated dilation
Description
Brachial artery flow-mediated dilation will assess endothelial dysfunction.
Time Frame
12 months postpartum
Title
Serum biomarkers of CVD risk
Description
Anti-angiogenic marker: Soluble fms-like tyrosine kinase (sFlt-1)
Time Frame
12 months postpartum
Title
arterial stiffness
Description
Carotid-femoral pulse wave velocity will assess arterial stiffness
Time Frame
12 months postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Palatnik, MD
Phone
4148056627
Email
apalatnik@mcw.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Zaira Peterson
Phone
(414) 805-6622
Email
zpeterson@mcw.edu
Facility Information:
Facility Name
Froedtert Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Intensive Postpartum Antihypertensive Treatment

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