[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06749418":3,"trial-entities:NCT06749418":109,"trial-summary:NCT06749418":112},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":36,"secondary_outcomes":45,"sex":56,"minimum_age":57,"maximum_age":58,"healthy_volunteers":59,"eligibility_criteria":60,"std_ages":78,"locations":80,"central_contacts":103,"overall_officials":105,"references":107,"see_also_links":108},"NCT06749418","202408643","Vascular Effects of High-Salt After Preeclampsia","Role of the Mineralocorticoid Receptor in Microvascular Endothelial Dysfunction After Preeclampsia","RECRUITING","2027-11-15","2026-02","2026-02-13","2025-01-02","Anna Stanhewicz, PhD","OTHER",false,"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. Importantly, women who had preeclampsia have an exaggerated vascular responsiveness to hypertensive stimuli, such as high-salt intake, compared to women who had a healthy pregnancy. The reason why this occurs is unclear but may be related to impaired endothelial function and dysregulation of the angiotensin system that occurs during the preeclamptic pregnancy and persists postpartum, despite the remission of clinical symptoms. While the association between a history of preeclampsia and vascular dysfunction leading to elevated CVD risk is well known, the mechanisms underlying this dysfunction remains unclear.\n\nThe purpose of this study is to examine the role of vascular mineralocorticoid receptor, the terminal receptor in the angiotensin system that contributes to blood pressure regulation, in mediating exaggerated microvascular endothelial dysfunction before and after a high-salt stimulus. This will help us better understand the mechanisms of microvascular dysfunction these women, and how inhibition of these receptors may improve microvascular function.\n\nIn this study, we use the blood vessels in the skin as a representative vascular bed for examining mechanisms of microvascular dysfunction in humans. Using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents) we examine the blood vessels in a nickel-sized area of the skin.",null,[19,20],"Preeclampsia","Preeclampsia Postpartum",[],"INTERVENTIONAL","BASIC_SCIENCE",[25],"EARLY_PHASE1",{"count":27,"type":28},40,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DRUG","Eplerenone","Local heating: eplerenone is locally and acutely delivered to the cutaneous microvasculature during local heating of the skin to assess endothelium-dependent dilation, L-NAME is added to assess nitric oxide-dependent dilation during this response.",[35],"High-salt supplement",[37,41],{"measure":38,"description":39,"timeFrame":40},"Change in microvascular endothelial function following local eplerenone treatment compared to placebo treatment measured by laser-Doppler flowmetry","Cutaneous vascular vasodilator response (cutaneous conductance; %max) to local heating of the skin; intradermal microdialysis for the local delivery of eplerenone compared to control (Ringer's solution), followed by L-NAME infusion to quantify NO-dependent response","Day 3 (low-salt diet run in) and Day 10 (low-salt diet + high-salt supplement)",{"measure":42,"description":43,"timeFrame":44},"Changes in 24-hour urine sodium","The investigators will measure urine sodium to ensure differences in salt-take between low- and high-salt.","Day 2, Day 9",[46,50,53],{"measure":47,"description":48,"timeFrame":49},"Changes in circulating aldosterone concentrations","The investigators will collect blood at the start of each experiment to determine differences in aldosterone concentrations between low- and high-salt.","Day 3, Day 10",{"measure":51,"description":52,"timeFrame":49},"Changes in circulating angiotensin II concentrations","The investigators will collect blood at the start of each experiment to determine differences in circulating angiotensin II concentrations between low- and high-salt.",{"measure":54,"description":55,"timeFrame":44},"Changes in ambulatory blood pressure","The investigators will measure ambulatory blood pressure, assessed as mean arterial pressure calculated from measured systolic and diastolic pressures, responses to low- and high-salt.","FEMALE","18 Years","45 Years",true,{"inclusion":61,"exclusion":65,"raw_text":77},[62,63,64],"women who had preeclampsia and women who did not have preeclampsia","12 weeks to 5 years postpartum","18-45 years old",[66,67,68,69,70,71,72,73,74,75,76],"history of hypertension or metabolic disease before pregnancy","history of gestational diabetes","history of gestational hypertension without preeclampsia","skin diseases","current tobacco use","current antihypertensive medication","statin or other cholesterol-lowering medication","currently pregnant","body mass index less than 18.5 kg\u002Fm2","allergy to materials used during the experiment.(e.g. latex),","known allergy to study drugs or salt-supplement","Inclusion Criteria:\n\n* women who had preeclampsia and women who did not have preeclampsia\n* 12 weeks to 5 years postpartum\n* 18-45 years old\n\nExclusion Criteria:\n\n* history of hypertension or metabolic disease before pregnancy\n* history of gestational diabetes\n* history of gestational hypertension without preeclampsia\n* skin diseases\n* current tobacco use\n* current antihypertensive medication\n* statin or other cholesterol-lowering medication\n* currently pregnant\n* body mass index less than 18.5 kg\u002Fm2\n* allergy to materials used during the experiment.(e.g. latex),\n* known allergy to study drugs or salt-supplement",[79],"ADULT",[81],{"facility":82,"status":8,"city":83,"state":84,"zip":85,"country":86,"contacts":87,"geoPoint":100},"University of Iowa","Iowa City","Iowa","52242","United States",[88,93,97],{"name":89,"role":90,"phone":91,"email":92},"Kelsey Schwartz, PhD","CONTACT","319-467-1732","kelsey-schwartz@uiowa.edu",{"name":94,"role":90,"phone":95,"email":96},"Claire Goebel","319-335-1914","claire-goebel@uiowa.edu",{"name":98,"role":99},"Anna Reid-Stanhewicz, PhD","PRINCIPAL_INVESTIGATOR",{"lat":101,"lon":102},41.66113,-91.53017,[104],{"name":89,"role":90,"phone":91,"email":92},[106],{"name":98,"affiliation":82,"role":99},[],[],{"nct_id":4,"conditions":110,"biomarkers":111},[19],[],{"nct_id":4,"found":59,"summary":113,"prompt_version":122},{"design":114,"status":115,"heading":6,"summary":116,"follow_up":117,"word_count":118,"commitments":119,"compensation":120,"drugs_mentioned":121},"This is an interventional study planning to enroll 40 women. It compares the effects of eplerenone to a placebo (an inactive substance) on blood vessel function.","completed","This study is looking into why women who have had preeclampsia (a serious blood pressure condition during pregnancy) might have a higher risk of heart problems later in life, especially how their bodies react to salt. Researchers are testing a drug called eplerenone to see how it affects blood vessel function in your skin when exposed to heat. They want to understand if problems with your blood vessels and a system in your body called the angiotensin system, which helps control blood pressure, are involved. To join, you must be a woman between 18 and 45 years old, and have given birth 12 weeks to 5 years ago, whether or not you had preeclampsia. The study aims to enroll 40 participants and is currently unclear about its recruitment status.","The primary endpoints are measured at Day 3 and Day 10, with urine samples collected on Day 2 and Day 9.",129,"You would undergo testing on Day 3 (while on a low-salt diet) and Day 10 (while on a low-salt diet with a high-salt supplement). You would also provide 24-hour urine samples on Day 2 and Day 9.","Not stated in the trial record.",[32],"v2"]