[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100437088":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":40,"centralContacts":44,"locations":55,"responsibleParty":73,"collaborators":75,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":87,"sex":88,"minAge":89,"maxAge":49,"enrollmentInfo":90,"targetDuration":49,"studyType":93,"phases":94,"briefSummary":97,"conditions":98,"keywords":105,"overallStatus":57,"whyStopped":49,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"University of Alabama at Birmingham","OTHER",[8,14,18,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Sacubitril\u002FValsartan Morning Dose","EXPERIMENTAL","We will enroll 40 adult obese individuals. Each participant will take the assigned dose of medication once in the morning and a placebo pill in the evening for 28 days. We evaluate Natriuretic Peptide-Renin-Angiotensin-Aldosterone System Rhythm Axis and Nocturnal Blood Pressure at baseline and after 28 days of intervention.",[13],"Drug: Sacubitril-Valsartan 49 Mg-51 Mg Oral Tablet",{"label":15,"type":10,"description":16,"interventionNames":17},"Sacubitril\u002FValsartan Evening Dose","We will enroll 40 adult obese individuals. Each participant will take the assigned dose of medication once in the evening and a placebo pill in the morning for 28 days. We evaluate Natriuretic Peptide-Renin-Angiotensin-Aldosterone System Rhythm Axis and Nocturnal Blood Pressure at baseline and after 28 days of intervention.",[13],{"label":19,"type":20,"description":11,"interventionNames":21},"Valsartan Morning Dose","ACTIVE_COMPARATOR",[22],"Drug: Valsartan 80 mg Oral Tablet",{"label":24,"type":20,"description":16,"interventionNames":25},"Valsartan Evening Dose",[22],[27,34],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Sacubitril-Valsartan 49 Mg-51 Mg Oral Tablet","The subject will be randomized, in a double-blind manner to sacubitril\u002Fvalsartan 49\u002F51 mg once in the morning or once in the evening for a period of 28 days.",[15,9],[33],"Sacubitril\u002FValsartan",{"type":28,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"Valsartan 80 mg Oral Tablet","The subject will be randomized, in a double-blind manner to valsartan 80 mg once in the morning or once in the evening for a period of 28 days.",[24,19],[39],"Valsartan",[41],{"name":42,"affiliation":5,"role":43},"Pankaj Arora, MD, FAHA","PRINCIPAL_INVESTIGATOR",[45,51],{"name":46,"role":47,"phone":48,"phoneExt":49,"email":50},"Nehal Vekariya, MS","CONTACT","205-934-7173",null,"nvekariya@uabmc.edu",{"name":52,"role":47,"phone":53,"phoneExt":49,"email":54},"Deborah Weber, BSN, RN","205-975-9964","dlowe@uabmc.edu",[56],{"facility":5,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"RECRUITING","Birmingham","Alabama","35294","United States","US",{"type":64,"coordinates":65},"Point",[66,67],-86.80249,33.52066,{"lat":67,"lon":66},[70,71],{"name":46,"role":47,"phone":48,"phoneExt":49,"email":50},{"name":72,"role":43,"phone":49,"phoneExt":49,"email":49},"Pankaj Arora, MD",{"type":43,"investigatorFullName":72,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":49,"oldOrganization":49},"Assistant Professor, Division of Cardiovascular Disease, Department of Medicine",[76],{"name":77,"class":78},"National Heart, Lung, and Blood Institute (NHLBI)","NIH","100437088","phase-2-precision-bp-precision-chronopharamacotherapy-targeting-np-raas-bp-rhythm-axis-100437088",false,"NCT04971720","PRECISION-BP: Precision Chronopharamacotherapy Targeting NP-RAAS-BP Rhythm Axis","Natriuretic Peptide-Renin-Angiotensin-Aldosterone System Rhythm Axis and Nocturnal Blood Pressure","PRECISION-BP","Inclusion Criteria:\n\n* Age more than or equal to 18 years of age\n* Body Mass Index between 30 to 45 kg\u002Fm\\^2\n* Blood pressure: Systolic BP more than or equal to 130mmHg and less than or equal to 160mmHg and diastolic blood pressure more than or equal to 80mmHg and less than or equal to 100mmHg. Individuals with hypertension as per the 2017 ACC\u002FAHA Guidelines will be eligible for enrollment\n\nExclusion Criteria:\n\n* Age less than 18, at screening.\n* Systolic BP \\\u003C130 or \\>160mmHg at baseline, or diastolic BP \\\u003C80 or \\>100 mmHg at baseline\n* BMI \\\u003C30 kg\u002Fm\\^2 or \\>45 kg\u002Fm\\^2\n* History of pulmonary hypertension\n* Have any past or present illness of cardiovascular disease including myocardial infarction, angina, cardiac arrhythmia, diabetes, stroke, TIA, or seizure.\n* Participants who are taking 3 or more classes of hypertension medications on the maximum dose or with resistant hypertension\n* History of angioedema\n* Estimated glomerular filtration rate (GFR) \\\u003C 60 ml\u002Fmin\u002F1.73 m2 (CKD-EPI equation); urine albumin creatinine ratio ≥30 mg\u002Fg\n* Hepatic Transaminase (AST and ALT) levels \\>3x the upper limit of normal;\n* Significant psychiatric illness\n* Anemia (men, Hct \\\u003C 38%; women, Hct \\\u003C36%)\n* Participants working night shifts or swing shifts\n* Women who are pregnant or breastfeeding or who can become pregnant and not practicing an acceptable method of birth control during the study (including abstinence)",true,"ALL","18 Years",{"count":91,"type":92},160,"ESTIMATED","INTERVENTIONAL",[95,96],"PHASE2","PHASE3","Obese individuals have a higher prevalence of nocturnal hypertension and non-dipping blood pressure (BP). These conditions are associated with an increased risk of cardiovascular (CV) events and death. Natriuretic Peptides (NPs) are hormones produced by the heart which directly regulate BP by causing dilation of blood vessels and by removing sodium and water from the body. NPs have a 24-hour day-night rhythm and this controls the day-night rhythm of BP as well. The NP-BP rhythm relationship is broken down in obese individuals. Obese individuals also have lower circulating NP levels. Lower circulating levels of NPs and elevated renin hormone (a part of the Renin-Angiotensin-Aldosterone System \\[RAAS\\]) at nighttime may contribute to the high nocturnal blood pressure in obese individuals which puts them at a higher risk of developing CV events. This current study seeks to determine the biological implications of chronopharmacology for synchronizing NP-RAAS-based blood pressure therapy with the physiological diurnal rhythms to restore the normal diurnal rhythm of blood pressure in obese individuals.",[99,100,101,102,103,104],"Obesity","Cardiovascular Diseases","Hypertension","Nocturnal Blood Pressure","Natriuretic Peptides","Renin-Angiotensin-Aldosterone System",[103,102,104,99],"2026-04-03",{"date":108,"type":109},"2026-04-09","ACTUAL",{"date":111,"type":109},"2022-02-18",{"date":113,"type":92},"2027-01-01",{"name":5,"class":6},1]