← Back to Search

Angiotensin II Receptor Blocker

Losartan for Preeclampsia (LIVE-PE Trial)

Phase < 1
Recruiting
Research Sponsored by Anna Stanhewicz, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.]
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up a total of 2 times throughout the study: 1) at the completion of 6 weeks of oral losartan treatment, and 2) at the completion of 6 weeks of placebo treatment
Awards & highlights

LIVE-PE Trial Summary

This trial will help us to understand how losartan may improve vascular function in women with a history of preeclampsia and give us insight into the mechanisms behind the increased risk of cardiovascular disease in these women.

Who is the study for?
This trial is for post-partum women over 18 who had preeclampsia in their last pregnancy within the past 24 months. Participants must be using birth control and not planning to get pregnant soon. They can't join if they have allergies to study drugs, use tobacco, have liver or metabolic diseases including CKD, had high blood pressure before pregnancy, gestational diabetes, are currently pregnant or breastfeeding, have skin diseases or a BMI under 18.5.Check my eligibility
What is being tested?
The study tests whether Losartan Potassium improves vascular function in women who've experienced preeclampsia by comparing it with a placebo. It involves examining blood vessels in the skin and analyzing inflammatory responses after taking either the medication or placebo.See study design
What are the potential side effects?
While specific side effects aren't listed here, Losartan may typically cause dizziness due to lowered blood pressure, mild stomach pain, diarrhea or heartburn among others. Placebo generally has no active effects but can lead to symptoms through expectation.

LIVE-PE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman over 18 who had preeclampsia in my last pregnancy within the last 2 years.

LIVE-PE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~a total of 2 times throughout the study: 1) at the completion of 6 weeks of oral losartan treatment, and 2) at the completion of 6 weeks of placebo treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and a total of 2 times throughout the study: 1) at the completion of 6 weeks of oral losartan treatment, and 2) at the completion of 6 weeks of placebo treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Central and Peripheral Vascular Stiffness following placebo
Central and Peripheral Vascular Stiffness following systemic AT1 receptor inhibition
Microvascular angiotensin II sensitivity following placebo
+3 more
Secondary outcome measures
PBMC inflammatory sensitivity
circulating inflammatory cytokines

Side effects data

From 2014 Phase 3 trial • 608 Patients • NCT00429364
10%
Dizziness
10%
Headache
6%
Fatigue
5%
Chest pain
4%
Agitation
4%
Syncope
3%
Epistaxis
3%
Insomnia
3%
Depression
3%
Palpitations
3%
Back pain
2%
Dyspnoea
2%
Anxiety
2%
Nightmare
2%
Abdominal pain NOS
2%
Chest wall pain
2%
Pain in extremity
2%
Stomach discomfort
2%
Personality change
1%
Urticaria NOS
1%
Sinusitis NOS
1%
Pruritus
1%
Cough
1%
Sinus infection
1%
Bronchospasm
1%
Infection with unknown ANC-upper ariway NOS
1%
Convulsions NOS
1%
Pneumothorax NOS
1%
Pneumonia
1%
Dehydration
1%
Conjunctivitis
1%
Constipation
1%
Diarrhoea NOS
1%
Dysgeusia
1%
Nausea
1%
Vomiting NOS
1%
Pyrexia
1%
Arthralgia
1%
Myalgia
1%
Cognitive disorder
1%
Extrapyramidal disorder
1%
Syncope vasovagal
1%
Nasal congestion
1%
Acne NOS
1%
Raynaud's Phenomena
1%
Edema:head and neck
1%
Mononucleosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Atenolol
Losartan

LIVE-PE Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: LosartanExperimental Treatment1 Intervention
6 weeks of daily (50mg/day) oral losartan potassium tablet
Group II: PlaceboPlacebo Group1 Intervention
6 weeks of daily oral placebo tablet
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Losartan Potassium
2007
Completed Phase 4
~1060

Find a Location

Who is running the clinical trial?

Anna Stanhewicz, PhDLead Sponsor
9 Previous Clinical Trials
360 Total Patients Enrolled

Media Library

Losartan Potassium (Angiotensin II Receptor Blocker) Clinical Trial Eligibility Overview. Trial Name: NCT04632589 — Phase < 1
Pre-eclampsia Research Study Groups: Losartan, Placebo
Pre-eclampsia Clinical Trial 2023: Losartan Potassium Highlights & Side Effects. Trial Name: NCT04632589 — Phase < 1
Losartan Potassium (Angiotensin II Receptor Blocker) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04632589 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum enrollment capacity of this trial?

"Affirmative, the information available from clinicaltrials.gov suggests that this research is actively enrolling volunteers. This project was first posted on November 22nd 2020 and has been recently updated on May 16th 2022. It requires 20 participants to be recruited at one location."

Answered by AI

Would I be eligible to participate in this experimental research?

"This medical study is recruiting 20 post-partum women aged 18 to 50 that have been diagnosed with preeclampsia. Furthermore, they must be utilizing an appropriate form of birth control and not plan to become pregnant in the next 6 months as per American College of Obstetricians and Gynecologists criteria for preeclampsia (information self reported by participants)."

Answered by AI

Are recruitment efforts underway for this trial?

"According to clinicaltrials.gov, this medical trial is presently recruiting patients for enrollment. It was initially posted on November 22nd 2020 and the last iteration of modifications took place on May 16th 2022."

Answered by AI

Has Losartan Potassium been trialed in other research premises?

"Presently, there are 30 investigations into the efficacy of Losartan Potassium with 2 trials in their final stage. While many of these studies take place at San Francisco medical centres, overall 533 locations across the country are running clinical trials involving this medication."

Answered by AI

Does this study encompass participants aged 20 or older?

"This medical trial is seeking individuals between the ages of 18 to 50 who meet its inclusion criteria. Separately, 13 research studies are open for people under eighteen and 73 investigations have been launched for those over 65 years old."

Answered by AI

How is Losartan Potassium typically employed to treat a medical condition?

"The common drug therapy for diabetic nephropathy is Losartan Potassium, which can also help mitigate left ventricular hypertrophy, proteinuria, and hypertensive disease."

Answered by AI
~1 spots leftby Jul 2024