[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"salt-sensitivity-of-blood-pressure\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:salt-sensitivity-of-blood-pressure":59},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,77],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100638026","salt-sensitivity-evaluation-via-n-of-1-trials-sense-salt-100638026",false,"NCT07614724","Salt Sensitivity Evaluation Via N-of-1 Trials (SENSE-Salt)","Determining the Presence of Salt Sensitivity in Individuals With Elevated Blood Pressure Through Dietary Salt Interventions: A Series of N-of-1 Trials","SENSE-Salt","Phase 1: Salt Sensitivity Screening\n\nInclusion:\n\n1. Signed informed consent for the salt sensitivity test.\n2. Systolic blood pressure between 110-159 mmHg and diastolic blood pressure between 70-99 mmHg.\n3. Not taking any antihypertensive medication, or have had a stable antihypertensive regimen for the past three months and agree not to adjust their medication during the study period.\n4. Able to comply with consuming the study-provided diet throughout the study period.\n\nExclusion:\n\n1. Special dietary requirements, such as allergies to common foods (e.g., eggs, seafood, peanuts), or conditions like asthma, irritable bowel syndrome, lactose intolerance, chronic kidney disease stage 4 or higher, history of gastrointestinal surgery, or special dietary needs due to other illnesses, surgery, or weight loss.\n2. Diagnosed with chronic diseases: any malignancy with a life expectancy of less than one year; chronic heart failure, severe depression or other mental disorders, long-term bedridden status, or mobility limitations.\n3. Experienced acute myocardial infarction or stroke within the past 6 months.\n4. Acute illnesses such as upper respiratory tract infection, fever, or severe diarrhea that have not yet resolved.\n5. Alcohol abuse.\n6. Pregnant or breastfeeding women, or women planning to become pregnant.\n7. Individuals who are deaf, mute, or have cognitive impairments that hinder communication.\n\nPhase 2: N-of-1 Trial\n\nInclusion:\n\n1. Classified as salt-sensitive or salt-resistant through the Phase 1 screening:\n2. Salt-Sensitive (SS) Group: Participants with a change in mean arterial pressure (ΔMAP) ≥ 5 mmHg and in the upper 1\u002F6 of the distribution of ΔMAP from the salt sensitivity test.\n3. Salt-Resistant (SR) Group: Participants with a change in mean arterial pressure (ΔMAP) \\\u003C 5 mmHg and in the lower 1\u002F6 of the distribution of ΔMAP from the salt sensitivity test.\n4. Signed informed consent for the n-of-1 trial.\n\nExclusion:\n\n1. Failed to complete the salt sensitivity test as required, or consumed less than 80% of the study-provided meals during the salt sensitivity test (i.e., fewer than 34 meals over 14 days).\n2. Experienced adverse events during the salt sensitivity test that, in the investigator's judgment, make it inappropriate to continue in the study.","ALL","20 Years","65 Years",{"count":21,"type":22},72,"ESTIMATED","INTERVENTIONAL",[25],"NA","Study Title: Determining the Presence of Salt Sensitivity in Individuals With Elevated Blood Pressure Through Dietary Salt Interventions: A Series of N-of-1 Trials\n\nObjective: To evaluate whether there are differences in blood pressure responses to dietary sodium intake between salt-sensitive and salt-resistant individuals, as identified through a salt sensitivity test. The study will use repeated dietary interventions with varying sodium content (high-sodium, low-sodium) to assess blood pressure responses in each individual, aiming to determine whether salt sensitivity is a present characteristic.\n\nStudy Design: This study will utilize an N-of-1 randomized controlled trial design. It consists of two phases:\n\nSalt Sensitivity Screening: A 2-week chronic salt-loading test will be used to identify salt-sensitive and salt-resistant individuals.\n\nN-of-1 Trial: The identified salt-sensitive and salt-resistant individuals will undergo a 6-week N-of-1 trial, consisting of three cycles, with each cycle including one week of low-sodium diet and one week of high-sodium diet. This design aims to assess individual blood pressure responses to changes in sodium intake.\n\nSample Size: A total of 72 participants will be recruited for the salt sensitivity screening, with an expected 24 participants proceeding to the N-of-1 trial.\n\nStudy Population: Healthy individuals aged 20-65 years, not on antihypertensive medication or with a stable regimen for at least 3 months, with systolic blood pressure between 110-159 mmHg and diastolic blood pressure between 70-99 mmHg, who are able to eat at the research center.\n\nPrimary Outcome: Reproducibility of salt sensitivity response classification. Secondary Outcomes: Changes in mean arterial pressure, systolic and diastolic blood pressure; exploratory outcomes such as sleep, mood, gut microbiome, metabolomics; safety outcomes including hypotension and hyponatremia.",[28,29],"Salt-Sensitivity of Blood Pressure","Hypertension",[31,32],"blood pressure","salt-sensitivity","NOT_YET_RECRUITING","2026-05-22",{"date":36,"type":37},"2026-05-29","ACTUAL",{"date":39,"type":22},"2026-06-01",{"date":41,"type":22},"2026-11-30",{"name":43,"class":44},"Peking University","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":57,"conditions":58,"keywords":63,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":45},"100639675","phase-2-effect-of-an-isolevuglandin-scavenger-on-salt-sensitivity-of-blood-pressure-and-immune-cell-activation-in-humans-100639675","NCT07602166","Effect of an Isolevuglandin Scavenger on Salt Sensitivity of Blood Pressure and Immune Cell Activation in Humans","Inclusion Criteria:\n\n* We will perform analyses in participants previously phenotyped for SSBP, defined as a change in systolic blood pressure ≥10 mmHg from salt-loading to salt-depletion,\n* Over 18 years of age. Able to give informed consent,\n\nExclusion criteria:\n\n* Salt-resistant people,\n* Acute cardiovascular event(s) within the previous 6 months,\n* inability to understand the nature, scope, and possible consequences of the study or to participate in\u002Fcomply with the protocol,\n* Current excessive alcohol or illicit drug use,\n* BP below the inclusion criteria levels after discontinuation of therapy,\n* Concomitant diabetes mellitus, type I or II,\n* Autoimmune disease,\n* Recent vaccination,\n* Younger or older than inclusion criteria,\n* Pregnant or breastfeeding\n* Women of childbearing potential unwilling to use highly effective contraceptive (see Risk section),\n* Confirmed or suspected renal, renovascular or endocrine causes of secondary hypertension,\n* Treatment with agents known to increase BP (e.g., adrenergic agonists for ADHD, SSRI and SNRI antidepressants, chronic use of decongestants or non-steroidal anti-inflammatory drugs,\n* Active or ongoing infection, including HIV\u002FAIDS,\n* Active or ongoing malignancy with the exception of basal cell carcinoma of the skin,\n* Severe psychiatric disorders,\n* Any condition that may alter the immunological results of the study including rheumatoid arthritis, systemic lupus erythematosus, dermatomyositis, giant cell arteritis, psoriasis, inflammatory bowel disease, and multiple sclerosis,\n* Use of glucocorticoids, immunosuppressants, direct immunomodulators or chemotherapeutic drugs that in the judgment of the investigators may include a major inflammatory component,\n* Individuals who have contraindications to high salt diets (e.g. heart, renal, or liver failure) or low salt diets (e.g. postural orthostatic tachycardia syndrome, prescribed salt tablets, fludrocortisone or midodrine) or 24-hr ambulatory blood pressure monitoring (e.g. women with bilateral upper extremity lymphedema following breast cancer surgeries),\n* Prior diagnosis of liver cirrhosis or the following abnormal liver function studies: AST or ALT \\>1.5x the upper limit of normal or total bilirubin ≥1.5 mg\u002Fdl,\n* Use of Aspirin,\n* Use of monoamine oxidase inhibitors (MAO-I),\n* Individuals with medical contraindications to certain food content,\n* Use of nitrate therapy. (Participants who are taking PDE-5 inhibitors will be instructed to discontinue use at least 48 hours prior to testing),\n* Patients with resistant hypertension, defined as above-goal blood pressure despite the concurrent use of three antihypertensive drug classes at screening, will be excluded for safety reasons,\n* Average of three office-based blood pressure readings greater than 160 mmHg systolic or 100 mmHg diastolic will not be eligible for enrollment,\n* Use of drugs such as anticoagulants (e.g., warfarin), beta-blockers, antiarrhythmics, antidepressants\u002Fantipsychotics, and other medications primarily metabolized by CYP2C9, CYP2C19, and CYP2D6 that may cause drug-drug interaction.","18 Years",{"count":54,"type":22},20,[56],"PHASE2","Hypertension is the leading cause of preventable deaths globally, driven by complications such as myocardial infarction, stroke, heart failure, and kidney disease. Recent updates in hypertension classification by the American Heart Association (AHA) place nearly half of the U.S. population in the hypertensive category. Excess dietary salt is a major risk factor for hypertension, with 50% of hypertensive individuals exhibiting salt-sensitivity of blood pressure (SSBP). SSBP is an independent predictor of cardiovascular events and death. While kidney mechanisms in salt-sensing have been extensively studied, emerging evidence suggests that immune cells can also sense sodium (Na+).\n\nThis trial hypothesizes that myeloid cell-derived isolevuglandins (IsoLGs) drive endothelial dysfunction, perpetuating the salt-sensitive phenotype. Preliminary data indicate that targeting IsoLGs with the IsoLG scavenger 2-hydroxybenzylamine (2-HOBA) may interrupt this immune-vascular axis, reducing salt sensitivity and associated cardiovascular risks.\n\nThis phase 2 clinical trial aims to investigate the role of 2-HOBA in modulating immune cell function within blood vessels in hypertensive patients. The study will explore the impact of immunity on salt sensitivity and assess 2-HOBA's potential to reduce endothelial dysfunction, improve immune cell activation, and alleviate SSBP.",[59,60,61,62],"Salt Sensitivity of Blood Pressure","High Blood Pressure","Inflammation","Renin-Angiotensin-Aldosterone System",[64,65,66,67],"salt sensitivity","hypertension","renin-angiotensin-aldosterone system","immune cells","2026-05-20",{"date":70,"type":37},"2026-05-26",{"date":72,"type":22},"2026-07",{"date":74,"type":22},"2031-07",{"name":76,"class":44},"Vanderbilt University Medical Center",{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":83,"sex":17,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":23,"phases":88,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":45},"100523371","phase-4-forebrain-electroneutral-transporters-in-salt-sensitive-hypertension-an-mri-study-100523371","NCT06094816","Forebrain Electroneutral Transporters in Salt-sensitive Hypertension: an MRI Study","Inclusion Criteria:\n\n* Age: \\> 40 years or \\\u003C 60 years\n* Blood pressure: \\> 100\u002F60 mmHg or \\\u003C 140\u002F90 mmHg\n* BMI: \\> 18.5 kg\u002Fm2 or \\\u003C 35 kg\u002Fm2\n* Serum potassium: \\> 3.5 mmol\u002FL or \\\u003C 5.5 mmol\u002FL\n* No history of cardiovascular, renal, metabolic, or neurological disease\n\nExclusion Criteria:\n\n* Age: \\\u003C 40 years or \\> 60 years\n* Blood pressure: \\\u003C 100\u002F60 mmHg or \\> 140\u002F90 mmHg\n* BMI: \\\u003C 18.5 kg\u002Fm2 or \\> 30 kg\u002Fm2\n* Serum potassium: \\\u003C 3.5 mmol\u002FL or \\> 5.5 mmol\u002FL\n* Abnormal ECG\n* History of - cardiovascular, cancer, metabolic, respiratory, renal disease\n* Hormone replacement therapy\n* Current tobacco or nicotine use\n* Pregnant or nursing mothers\n* Major brain injury (concussions do not count)\n* Clinically diagnosed psychiatric or neurological disorder\n* Clinically diagnosed anxiety or depression\n* Psychiatric, neurological, anxiety or depression medications\n* Hypertension medications\n* Sulfonamide drug allergy\n* Contra-indications to MRI (implants, metal, etc)\n* Claustrophobia",true,"40 Years","60 Years",{"count":87,"type":22},120,[89],"PHASE4","The overall objective of this project is to identify the key salt-sensing regions of the brain and determine the underlying mechanism of sodium sensing. The investigators will assess how the brain responds to an acute increase of salt in the blood using MRI. This will be done during a 30-minute infusion of a saline solution containing 3% salt. One trial will be conducted with a salt sensing channel blocker and one trial without the salt sensing channel blocker. This will help to assess the role of a specific salt sensing channel in the brain. Salt sensitivity of BP will be assessed using 7-day dietary feeding where participants will be given food to consume for 7-days. Comparisons will be made between salt resistant (no change in blood pressure going from low to high salt diets) and salt sensitive adults (a change in blood pressure going from low to high salt diets). The investigators think the changes in MRI will be greater in salt sensitive compared to salt resistant subjects.",[28],"RECRUITING","2026-03-20",{"date":95,"type":37},"2026-03-24",{"date":97,"type":37},"2024-03-05",{"date":99,"type":22},"2028-07-01",{"name":101,"class":44},"University of Delaware"]