[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"left-ventricular-diastolic-dysfunction\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:left-ventricular-diastolic-dysfunction":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,82],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":45,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":81},"100420250","pediatric-hypertension-and-the-renin-angiotensin-system-phrase-100420250",false,"NCT04752293","Pediatric Hypertension and the Renin-Angiotensin SystEm (PHRASE)","Pediatric Hypertension and the Renin-Angiotensin SystEm (PHRASE): The Role of Angiotensin-(1-7) in Hypertension and Hypertension-Induced Heart and Kidney Damage","PHRASE","INCLUSION CRITERIA: HYPERTENSION COHORT\n\n* 7-18 years of age at time of enrollment\n* Confirmed new diagnosis of primary hypertension: no identifiable secondary cause, referred to hypertension or nephrology clinic\n\n  * Age \\\u003C13 years: BP ≥95th %ile or ≥130\u002F80 mmHg (whichever is lower)\n  * Age ≥13 years: BP ≥130\u002F80 mmHg\n* Participants and their caregivers must be willing and able to commit to completing the study assessments\n\nEXCLUSION CRITERIA: HYPERTENSION COHORT\n\n* \\\u003C7 years or \\>18 years of age at time of enrollment\n* BP confirmed as normal or in the elevated BP category based on ≥3 prior office BP measurements on separate days;\n\n  * Age \\\u003C13 years: BP \\\u003C95th %ile or \\\u003C130\u002F80 mmHg (whichever is lower)\n  * Age ≥13 years: BP \\\u003C130\u002F80 mmHg\n* A confirmed secondary cause of hypertension\n* Confounding medical condition (heart or kidney disease \\[except hypertension-associated heart changes on echocardiogram or albuminuria\\], vascular\u002Finflammatory disease, or diabetes)\n* Inability to complete study assessments\n* Non-English\u002FSpanish speakers\n* Current pregnancy\n* Ward of the State\n\nINCLUSION CRITERIA: CONTROL COHORT\n\n* 7-18 years of age at time of enrollment\n* Normal BP based on ≥3 prior office BP measurements on separate days;\n\n  * Age \\\u003C13 years: BP \\\u003C90th %ile or \\\u003C120\u002F80 mmHg (whichever is lower)\n  * Age ≥13 years: BP \\\u003C120\u002F80 mmHg\n* Participants and their caregivers must be willing and able to commit to completing the study assessments\n\nEXCLUSION CRITERIA: CONTROL COHORT\n\n* \\\u003C7 or \\>18 years of age at time of enrollment\n* Elevated BP or hypertension, based on ≥3 prior office BP measurements on separate days:\n\n  * Age \\\u003C13 years: BP ≥90th %ile or ≥120\u002F80 mmHg (whichever is lower)\n  * Age ≥13 years: BP ≥120\u002F80 mmHg\n* History of elevated BP or hypertension\n* Current use of BP-lowering medications\n* Confounding medical condition (heart or kidney disease, vascular\u002Finflammatory disease, or diabetes)\n* Inability to complete study assessments\n* Non-English\u002FSpanish speakers\n* Current pregnancy\n* Ward of the State",true,"ALL","7 Years","18 Years",{"count":22,"type":23},125,"ESTIMATED","OBSERVATIONAL","Studying the causal roles of components of the renin-angiotensin-aldosterone system (including angiotensin-(1-7) (Ang-(1-7)), angiotensin-converting enzyme 2 (ACE2), Ang II, and ACE), uric acid, and klotho in pediatric hypertension and related target organ injury, including in the heart, kidneys, vasculature, and brain. Recruiting children with a new hypertension diagnosis over a 2-year period from the Hypertension and Pediatric Nephrology Clinics affiliated with Brenner Children's Hospital at Atrium Health Wake Forest Baptist and Atrium Health Levine Children's Hospital. Healthy control participants will be recruited from local general primary care practices. Collecting blood and urine samples to analyze components of the renin-angiotensin-aldosterone system (Ang-(1-7), ACE2, Ang II, ACE), uric acid, and klotho, and measuring blood pressure, heart structure and function, autonomic function, vascular function, and kidney function at baseline, year 1, and year 2. Objectives are to investigate phenotypic and treatment response variability and to causally infer if Ang-(1-7), ACE2, Ang II, ACE, uric acid, and klotho contribute to target organ injury due to hypertension.",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44],"Hypertension","Left Ventricular Hypertrophy","Left Ventricular Dysfunction","Left Atrial Dilatation","Left Ventricular Diastolic Dysfunction","Kidney Diseases","Kidney Injury","Kidney Dysfunction","Sodium Urine High","Blood Pressure Disorders","Uric Acid Retention","Angiotensin Hypertension","Autonomic Dysfunction","Autonomic Imbalance","Pediatric Kidney Disease","Pediatric Obesity","Proteinuria","Albuminuria",[46,47,27,48,49,28,44,50,51,52,53,54,55,56,57,58,59,60,61,62,31,33,63,64,42,65,66,67,68],"High Blood Pressure","Elevated Blood Pressure","Pediatric Hypertension","Target Organ Damage","Uric Acid","Klotho","Fibroblast Growth Factor 23","Renin-Angiotensin-Aldosterone System","Renin-Angiotensin System","Angiotensin-(1-7)","Angiotensin II","Angiotensin-Converting Enzyme 2","Angiotensin-Converting Enzyme","Causal Inference","Causal Mediation Analysis","Sensitivity Analysis","Predictive Analysis","Heart Rate Variability","Sodium","Lifecourse","Kidney Function","Ambulatory Blood Pressure Monitoring","Echocardiogram","RECRUITING","2025-12-04",{"date":72,"type":73},"2025-12-11","ACTUAL",{"date":75,"type":73},"2021-05-19",{"date":77,"type":23},"2026-12",{"name":79,"class":80},"Wake Forest University Health Sciences","OTHER",1,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":18,"minAge":20,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":102,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":81},"100549277","carvedilol--simvastatin-vs-carvedilol-alone-for-cirrhosis-and-cirrhotic-cardiomyopathy-and-impact-on-hepatic-decompensation-and-survival-100549277","NCT06431919","Carvedilol + Simvastatin vs. Carvedilol Alone for Cirrhosis and Cirrhotic Cardiomyopathy and Impact on Hepatic Decompensation and Survival","Carvedilol + Simvastatin vs. Carvedilol Alone for Chronic Liver Disease and Cirrhotic Cardiomyopathy and Its Impact on Hepatic Decompensation and Survival; a Double-blind Randomized Controlled Trial","CIRROSTAT","Inclusion Criteria:\n\n* Age range of 18-65 years\n* Compensated cirrhosis, as diagnosed by histology or clinical, laboratory and USG findings,\n* CCM (with EF\\>50%) on 2D echocardiography with TDI\n* Written informed consent.\n\nExclusion Criteria:\n\n* Age \\>65 years\n* Serum Creatinine\\>2 mg\u002Fdl\n* Patient previously treated with statin (one month before the study)\n* Contraindications to statins\n* Advanced Cirrhosis (CTP score\\>9)\n* Coronary artery disease\n* Sick sinus syndrome\u002F Pacemaker, valvular heart disease\n* Cardiac rhythm disorder, Peripartum cardiomyopathy\n* Portopulmonary hypertension\u002F hepatopulmonary syndrome\n* Transjugular intrahepatic portosystemic shunt (TIPS) insertion\n* Hepatocellular carcinoma\n* Pregnancy or lactation\n* Patients with HIV or retroviral therapy\n* Anemia Hb \\\u003C 8gm\u002Fdl in females, and \\\u003C 9 gm\u002Fdl in males\n* Acute variceal bleeding in last 6 months.\n* Need for medications, metabolized by CYP3A4(such as amlodipine, verapamil, fenofibrate azole antibiotics, protease inhibitors etc.)","65 Years",{"count":92,"type":23},260,"INTERVENTIONAL",[95],"NA","Cirrhosis and portal hypertension are associated with a hyperdynamic circulation and decompensation events, including development of ascites, variceal bleeding, acute kidney injury, and susceptibility to infections.\n\nRationale:\n\nCirrhosis and portal hypertension are associated with a hyperdynamic circulation and decompensation events, including ascites, variceal bleeding, acute kidney injury, and susceptibility to infections. CCM, present in 30-70% of patients, is characterized by structural and functional abnormalities in the heart, and is associated with progression of cirrhosis, impaired quality of life and poor survival. Statins play a crucial role in reducing proatherogenic LDL cholesterol levels, making them a cornerstone in managing diabetes and cardiovascular diseases (CVDs) with the aim of decreasing or reversing atherosclerosis. This trial aims to evaluate the impact and safety of simvastatin in cirrhotic cardiomyopathy.\n\nNovelty: Simvastatin might be of special value in diastolic dysfunction through its hemodynamic and functional effects on LV remodeling and improve portal hemodynamics through the pleotropic effects of lipophilic statins.\n\nObjectives:\n\nThe primary objective is to assess the combined effects of carvedilol and simvastatin in managing CCM vs carvedilol alone for a composite outcome to prevent decompensation and reduce all-cause mortality. We will comprehensively evaluate cardiac function, decompensation events and survival based on impact of simvastatin over the standard betablocker carvedilol.\n\nMethods:\n\nThis is a double-blinded randomized placebo-controlled trial involving patients diagnosed with CCM. Clinical data, including cardiac imaging, cardiac biomarkers, and survival outcomes, will be assessed for either group.\n\nExpected Outcome:\n\nThe investigators anticipate that the synergistic use of simvastatin and carvedilol will effectively reduce portal pressure, improve portal haemodynamic, and enhance cardiac remodelling. Successful reversal of LVDD can potentially prevent clinical events such as ascites, encephalopathy, and acute kidney injury (AKI).",[98,99,100,31,101],"Decompensated Cirrhosis","Cirrhotic Cardiomyopathy","Cirrhosis, Liver","Acute Kidney Injury",[98,99,103,104],"Left ventricular diastolic dysfunction","Acute kidney injury","2025-06-05",{"date":107,"type":73},"2025-06-08",{"date":109,"type":23},"2025-06-10",{"date":111,"type":23},"2028-02",{"name":113,"class":80},"Post Graduate Institute of Medical Education and Research, Chandigarh"]