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Trial record 3 of 3 for:    "Eclampsia" | "Serine"

Angiotensin II and Chronic Inflammation in Persistent Microvascular Dysfunction Following Preeclampsia

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ClinicalTrials.gov Identifier: NCT03482440
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : September 17, 2019
Sponsor:
Collaborator:
Penn State University
Information provided by (Responsible Party):
Anna Stanhewicz, PhD, University of Iowa

Brief Summary:
Women who develop preeclampsia during pregnancy are more likely to develop 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 1) determine the mechanisms contributing to this lasting blood vessel damage and chronic inflammation, and to 2) identify factors (both physiological and pharmacological) that mitigate these negative effects in order to inform better clinical management of cardiovascular disease risk in women who have had preeclampsia.

Condition or disease Intervention/treatment Phase
Preeclampsia Drug: Salsalate Oral Tablet Drug: Placebo Oral Tablet Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Role of Angiotensin II and Chronic Inflammation in Persistent Microvascular Dysfunction Following Preeclamptic Pregnancy
Actual Study Start Date : August 26, 2018
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo Oral Tablet
Placebo oral table twice daily for 5 days prior to experimental testing

Experimental: Salsalate Drug: Salsalate Oral Tablet
1500mg twice daily for 5 days prior to experimental testing




Primary Outcome Measures :
  1. change in endothelial function following salsalate treatment compared to placebo treatment [ Time Frame: a total of 2 times throughout the study (approximately 4 weeks): 1) at the completion of 5 days of oral salsalate treatment, and 2) at the completion of 5 days of placebo treatment ]
    Endothelium-dependent vasodilation assessed by reactivity to exogenous acetylcholine


Secondary Outcome Measures :
  1. change in inflammatory response to ang II compared to baseline [ Time Frame: a total of 3 times throughout the study (approximately 4 weeks): 1) at the beginning of the study, 2) at the completion of the 5 day placebo treatment, and 3) at the completion of 5 days of oral salsalate treatment ]
    inflammatory cytokine release by isolated peripheral blood mononuclear cells



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Post-partum women who have delivered within two years and who have had a preeclamptic pregnancy diagnosed by their obstetrician before 34 weeks of gestation and confirmed according to the American College of Obstetricians and Gynecologists criteria for severe preeclampsia. [This information will be self-reported by the subjects.]
  • Post-partum women who have delivered within two years and who have had a normal pregnancy.
  • 18 years and older.

Exclusion Criteria:

  • skin diseases
  • current tobacco use
  • diagnosed or suspected hepatic or metabolic disease
  • statin or other cholesterol-lowering medication
  • history of hypertension prior to pregnancy
  • history of gestational diabetes
  • current pregnancy
  • allergy to aspirin or NSAIDs or known allergy to materials used during the experiment (e.g. latex)
  • renal disease, bleeding disorders and history of gastrointestinal bleeding.
  • Known allergies to study drugs
  • Taking blood thinners, aspirin or NSAIDS.
  • Women who choose to breastfeed will not participate in any parts of the project that include salsalate.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03482440


Contacts
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Contact: Anna Stanhewicz, PhD 319-467-1732 anna-stanhewicz@uiowa.edu

Locations
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United States, Iowa
University of Iowa Not yet recruiting
Iowa City, Iowa, United States, 52242
Contact: Anna Stanhewicz, PhD    319-467-1732    anna-stanhewicz@uiowa.edu   
United States, Pennsylvania
Pennsylvania State University Recruiting
University Park, Pennsylvania, United States, 16802
Contact: Sue Slimak, RN    814-863-8556    sks31@psu.edu   
Sponsors and Collaborators
University of Iowa
Penn State University
Investigators
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Principal Investigator: Anna Stanhewicz, PhD University of Iowa

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Responsible Party: Anna Stanhewicz, PhD, Principal Investigator, University of Iowa
ClinicalTrials.gov Identifier: NCT03482440     History of Changes
Other Study ID Numbers: HL138133
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual participant data will be shared

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anna Stanhewicz, PhD, University of Iowa:
preeclampsia
microvascular
inflammation
angiotensin II
Additional relevant MeSH terms:
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Pre-Eclampsia
Serine Proteinase Inhibitors
Inflammation
Pathologic Processes
Hypertension, Pregnancy-Induced
Pregnancy Complications
Salicylsalicylic acid
Sodium Salicylate
Angiotensin II
Giapreza
Angiotensinogen
Vasoconstrictor Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors