Losartan for Improved Vascular Endothelial Function After Preeclampsia (LIVE-PE)

Anna Stanhewicz, PhD

Status and phase: Completed; Early Phase 1

Conditions: Preeclampsia Postpartum

Treatments: Drug: Losartan Potassium; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04632589

202006148

Details and patient eligibility

About

Women who develop preeclampsia during pregnancy are more likely to develop and die of cardiovascular disease later in life, even if they are otherwise healthy. The reason why this occurs is unclear but may be related to blood vessel damage and increased inflammation that occurs during the preeclamptic pregnancy and persists postpartum. The purpose of this investigation is to determine the mechanisms contributing to this lasting blood vessel damage and to test whether taking a medication that blocks angiotensin II receptors (losartan) decrease these negative effects in women who have had preeclampsia. Identification of these mechanisms and treatment strategies may lead to better clinical management,of cardiovascular disease risk in these women.

In this study we use the blood vessels in the skin as a representative vascular bed. Using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents) we examine the blood vessels in a nickle-sized area of the skin in women who have had preeclampsia. We make these measurements after the subjects take a placebo and after they take losartan (an angiotensin II receptor blocker) to test whether this treatment improves vascular function in these women. As a compliment to these measurements, we also draw blood from the subjects and isolate the inflammatory cells to test how sensitive their inflammatory responses are following the placebo and the losartan treatment.

Enrollment: 11 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Post-partum women,

• 18 years or older,
• who have delivered within 24 months of the study visit
• who have had a preeclamptic pregnancy diagnosed by their obstetrician and confirmed according to the American College of Obstetricians and Gynecologists criteria for preeclampsia. [This information will be self-reported by the subjects.]
• Using an effective method of birth control and not planning to become pregnant in the next 6 months.

Exclusion criteria

• skin diseases,
• current tobacco use,
• diagnosed or suspected hepatic or metabolic disease including chronic kidney disease (CKD) defined as reduced eGFR < 60 mL/min/1.73m2,
• statin or other cholesterol-lowering medication,
• current antihypertensive medication,
• history of hypertension prior to pregnancy,
• history of gestational diabetes,
• current pregnancy or breastfeeding,
• body mass index <18.5 kg/m2,
• allergy to materials used during the experiment.(e.g. latex),
• known allergies to study drugs.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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11 participants in 2 patient groups, including a placebo group

Losartan

Experimental group

Description:

6 weeks of daily (50mg/day) oral losartan potassium tablet

Treatment:

Drug: Losartan Potassium

Placebo

Placebo Comparator group

Description:

6 weeks of daily oral placebo tablet

Treatment:

Drug: Placebo