[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06169540":3,"trial-entities:NCT06169540":81,"trial-summary:NCT06169540":86},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":25,"interventions":28,"primary_outcomes":29,"secondary_outcomes":38,"sex":39,"minimum_age":40,"maximum_age":23,"healthy_volunteers":14,"eligibility_criteria":41,"std_ages":52,"locations":55,"central_contacts":70,"overall_officials":75,"references":79,"see_also_links":80},"NCT06169540","2022P003352","Salivary Extracellular Vesicle Associated lncRNAs in Heart Failure (SEAL-HF)","RECRUITING","2027-12-31","2025-11","2025-11-13","2023-04-19","Massachusetts General Hospital","OTHER",false,"The purpose of this study is to determine the relationship between the levels of Ribonucleic acid (RNA) circulating molecules, including ones in extracellular vesicles from different organs in the blood and in the saliva of patients with Acute Decompensated Heart Failure (ADHF) and Chronic Heart Failure (CHF) to see if a new, non-invasive diagnostic test can be developed for heart failure exacerbation.","The primary objective of this study is to investigate the expression of extracellular vesicle RNAs (evRNAs) during admission for and decongestion of ADHF patients and determine their diagnostic and prognostic potential. The main hypothesis is that these evRNAs are dynamically regulated in response to volume status changes. Thus, the aim is to delineate: i) the utility of salivary evRNA expression in discriminating ADHF from compensated chronic heart failure states in ADHF patients, chronic heart failure patients and controls (n=30 each); and ii) assess changes in expression in ADHF patients during decongestion. Plasma and salivary evRNA levels will be correlated to determine accuracy of salivary Extracellular Vesicles (EVs) to reflect changes in plasma.\n\nThis is a multi-cohort study that will make use of clinical saliva and plasma samples of 90 subjects across three groups. The first group will consist of 30 patients admitted to the hospital for ADHF (clinical samples will be collected during acute decompensation and after diuresis of ADHF patients). The second group will consist of 30 patients with chronic heart failure who are seen in the outpatient clinic. The control group will also include 30 patients undergoing electrophysiology procedures recruited through the Electrophysiology Lab (EP). For each group, blood plasma and saliva samples will be obtained.",[18,19,20],"CHF","ADHF","Control",[],"OBSERVATIONAL",null,[],{"count":26,"type":27},90,"ESTIMATED",[],[30,33,36],{"measure":31,"timeFrame":32},"Association between weight change (kg), fluid balance (cumulative fluid intake and output, mL), clinical response to diuretic therapy (as judged by a physician), and salivary biomarker levels assessed by quantitative Polymerase Chain Reaction (qPCR)","Through study completion, an average of 1 year",{"measure":34,"description":35,"timeFrame":32},"Rehospitalization event prediction","Linear regression analysis for biomarker prediction of subsequent hospital admissions.",{"measure":37,"timeFrame":32},"Association between known biomarkers (NT-proBNP), volume status (right heart catheterization data, echocardiographic data), and salivary biomarker level assessed by qPCR",[],"ALL","18 Years",{"inclusion":42,"exclusion":47,"raw_text":51},[43,44,43,45,43,46],"At least 18 years of age","Stable disease defined as CHF of any type, New York Heart Association (NYHA) functional class II\u002FIII\u002FIV, N-terminal pro-B-type natriuretic peptide (NT-proBNP) ≥600 pg\u002Fml if Left Ventricular Ejection Fraction (LVEF) ≤30%; ≥1000 pg\u002FmL if LVEF 31-35%; ≥2500 pg\u002FmL if EF \\>35%","Clinical signs and\u002For symptoms (including exertional or rest dyspnea, orthopnea or Paroxysmal Nocturnal Dyspnea (PND)) and N-terminal pro-BNP level \\> 1000 pg\u002FmL or BNP \\> 400 pg\u002Fml, OR Clinical evidence of congestion: X-ray evidence of pulmonary edema or pleural effusions, elevated Jugular Venous Pulse (JVP), lower extremity edema, or rales on pulmonary examination, right heart catheterization evidence of elevated filling pressures (Right Atrium (RA) pressure \\> 10 mmHg; Pulmonary Capillary Wedge Pressure (PCWP) \\> 18 mmHg) and clinical response to Intravenous (IV) diuretic therapy (as judged by a physician)","Will\u002Fhave undergone an EP procedure in the EP lab",[48,49,50],"Active pregnancy or lactation","Cardiac amyloidosis","Active malignancies","Inclusion Criteria CHF:\n\n* At least 18 years of age\n* Stable disease defined as CHF of any type, New York Heart Association (NYHA) functional class II\u002FIII\u002FIV, N-terminal pro-B-type natriuretic peptide (NT-proBNP) ≥600 pg\u002Fml if Left Ventricular Ejection Fraction (LVEF) ≤30%; ≥1000 pg\u002FmL if LVEF 31-35%; ≥2500 pg\u002FmL if EF \\>35%\n\nInclusion Criteria ADHF:\n\n* At least 18 years of age\n* Clinical signs and\u002For symptoms (including exertional or rest dyspnea, orthopnea or Paroxysmal Nocturnal Dyspnea (PND)) and N-terminal pro-BNP level \\> 1000 pg\u002FmL or BNP \\> 400 pg\u002Fml, OR Clinical evidence of congestion: X-ray evidence of pulmonary edema or pleural effusions, elevated Jugular Venous Pulse (JVP), lower extremity edema, or rales on pulmonary examination, right heart catheterization evidence of elevated filling pressures (Right Atrium (RA) pressure \\> 10 mmHg; Pulmonary Capillary Wedge Pressure (PCWP) \\> 18 mmHg) and clinical response to Intravenous (IV) diuretic therapy (as judged by a physician)\n\nInclusion Criteria control:\n\n* At least 18 years of age\n* Will\u002Fhave undergone an EP procedure in the EP lab\n\nExclusion Criteria:\n\n* Active pregnancy or lactation\n* Cardiac amyloidosis\n* Active malignancies",[53,54],"ADULT","OLDER_ADULT",[56],{"facility":12,"status":7,"city":57,"state":58,"zip":59,"country":60,"contacts":61,"geoPoint":67},"Boston","Massachusetts","02114","United States",[62],{"name":63,"role":64,"phone":65,"email":66},"Saumya Das, MD, PhD","CONTACT","617-724-4500","sdas@mgh.harvard.edu",{"lat":68,"lon":69},42.35843,-71.05977,[71,72],{"name":63,"role":64,"phone":65,"email":66},{"name":73,"role":64,"email":74},"Priyanka Gokulnath, PhD","PGOKULNATH@mgh.harvard.edu",[76],{"name":77,"affiliation":12,"role":78},"Michail Spanos, MD","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":82,"biomarkers":85},[83,84],"Chronic heart failure","Decompensated chronic heart failure",[],{"nct_id":4,"found":87,"summary":88,"prompt_version":98},true,{"design":89,"status":90,"heading":91,"summary":92,"follow_up":93,"word_count":94,"commitments":95,"compensation":96,"drugs_mentioned":97},"This is an observational study involving 90 participants across three groups: ADHF patients, CHF patients, and a control group. It is not a randomized or blinded study.","completed","Observational Study on Salivary RNA in Heart Failure (SEAL-HF)","This study, called SEAL-HF, is looking into whether certain RNA molecules found in your saliva could help doctors diagnose and predict problems in people with heart failure. Researchers want to see if these RNA levels change when heart failure gets worse (Acute Decompensated Heart Failure or ADHF) or stays stable (Chronic Heart Failure or CHF). They will compare saliva samples from people with ADHF, CHF, and healthy individuals. The goal is to develop a simple, non-invasive (meaning it doesn't involve needles or surgery) test to better manage heart failure. To join, you must be at least 18 years old and have either stable CHF or ADHF, with specific levels of a heart failure biomarker called NT-proBNP. The study aims to enroll 90 participants.","The study will follow participants through completion, which is an average of one year, to assess rehospitalization events and associations with salivary biomarker levels.",123,"You would provide blood plasma and saliva samples. For ADHF patients, samples will be collected during acute decompensation and after treatment. For CHF and control groups, samples will be taken during clinic visits or electrophysiology procedures.","Not stated in the trial record.",[],"v2"]