[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03480633":3,"trial-entities:NCT03480633":111,"trial-summary:NCT03480633":122},{"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":24,"study_type":32,"primary_purpose":15,"phases":33,"enrollment_info":34,"interventions":37,"primary_outcomes":38,"secondary_outcomes":43,"sex":59,"minimum_age":60,"maximum_age":15,"healthy_volunteers":61,"eligibility_criteria":62,"std_ages":75,"locations":78,"central_contacts":94,"overall_officials":103,"references":105,"see_also_links":110},"NCT03480633","2016P000339","Biomechanical Precision Medicine Registry for Patients With and Without Heart Failure","Preserved vs. Reduced Ejection Fraction Biomarker Registry and Precision Medicine Database for Ambulatory Heart Failure Patients (PREFER-HF) Study","RECRUITING","2027-10-06","2025-12","2025-12-09","2016-04-07","Massachusetts General Hospital","OTHER",null,"In this single-center, longitudinal observational study, we will comprehensively examine clinical characteristics, proteomic, metabolomic, genomic and imaging data to better understand how different heart failure types may develop and progress over time. We will evaluate distinct sub-groups of heart failure (also known as heart failure phenotypes) and cardiomyopathies including amyloidosis with an ultimate goal of bringing the right medications and therapy to the right patients to optimize benefit and minimized side effects, an effort to improve precision medicine in heart failure.","Patients 18-years and older with and without heart failure (across all left ventricular ejection fraction) and cardiomyopathies including amyloidosis will be enrolled in this single center, longitudinal observational Registry.\n\nBaseline and one-year follow up blood samples including DNA as well as clinical characteristics, events leading up to heart failure diagnosis, etiology of heart failure, the presence and duration of other medical problems, laboratory, echocardiographic data and images, and therapy information will be obtained.\n\nClinical outcomes of interest include major adverse cardiovascular events (a combination of all-cause death and heart failure hospitalizations), individual endpoints of all-cause death, cardiovascular death, all-cause hospitalization, cardiovascular hospitalization, heart failure hospitalization, right-sided heart failure, and kidney injury.\n\nResults from the Preserved vs. Reduced Ejection Fraction Biomarker Registry and Precision Medicine Database for Ambulatory Heart Failure Patients (PREFER-HF) trial will comprehensively examine longitudinal clinical characteristics, proteomic, metabolomic, genomic and imaging data to better understand pathophysiology of heart failure and phenotypes in heart failure with an ultimate goal of improving precision medicine in heart failure.",[19,20,21,22,23],"Heart Failure With Normal Ejection Fraction","Heart Failure With Reduced Ejection Fraction","Heart Failure, Right Sided","Heart Failure With Mid Range Ejection Fraction","Cardiovascular Risk Factor",[25,26,27,28,29,30,31],"Heart failure","Precision medicine","High risk patients","Pathophysiology","Bioregistry","Biomarkers","Heart failure etiology","OBSERVATIONAL",[],{"count":35,"type":36},3000,"ESTIMATED",[],[39],{"measure":40,"description":41,"timeFrame":42},"Major adverse cardiovascular events (MACE)","MACE as defined by a combined end point of all-cause mortality and HF hospitalizations.","Time from sample collection until the date of documented event up to 60 months after the study closure.",[44,47,49,51,53,55,57],{"measure":45,"description":46,"timeFrame":42},"Time to event: all-cause mortality","Medical records and phone follow-up with patients and\u002For their physicians will allow the investigators to ascertain vital status and any significant clinical events.",{"measure":48,"description":46,"timeFrame":42},"Time to event: cardiovascular mortality",{"measure":50,"description":46,"timeFrame":42},"Time to event: all-cause hospitalization",{"measure":52,"description":46,"timeFrame":42},"Time to event: cardiovascular hospitalization",{"measure":54,"description":46,"timeFrame":42},"Time to event: HF hospitalization",{"measure":56,"description":46,"timeFrame":42},"Time to event: Right-sided HF",{"measure":58,"description":46,"timeFrame":42},"Time to event: acute kidney injury","ALL","18 Years",true,{"inclusion":63,"exclusion":73,"raw_text":74},[64,65,66,67,68,69,70,71,72],"18 years and older","History of clinical symptoms consistent with HF and at least one of the following supporting evidence of HF:","NT-proBNP \\> 125 pg\u002FmL","BNP \\> 35 pg\u002FmL","Capillary wedge pressure ≥ 15 mmHg on right heart catheterization or CI \\\u003C2.8 L\u002Fmin\u002Fm2","LVEDP ≥ 15 mmHg","Radiographic evidence of pulmonary edema","Improvement in symptoms with diuretic initiation of increase","CPET evidence of cardiac etiology of symptoms",[],"Inclusion criteria for patients with HF:\n\n* 18 years and older\n* History of clinical symptoms consistent with HF and at least one of the following supporting evidence of HF:\n\n  * NT-proBNP \\> 125 pg\u002FmL\n  * BNP \\> 35 pg\u002FmL\n  * Capillary wedge pressure ≥ 15 mmHg on right heart catheterization or CI \\\u003C2.8 L\u002Fmin\u002Fm2\n  * LVEDP ≥ 15 mmHg\n  * Radiographic evidence of pulmonary edema\n  * Improvement in symptoms with diuretic initiation of increase\n  * CPET evidence of cardiac etiology of symptoms\n\nHFpEF: LVEF ≥ 50% HFrEF: LVEF \\\u003C50%\n\nExclusion criteria (for all patients, including both those with HFpEF and HFrEF):\n\n\\- End stage renal disease on dialysis",[76,77],"ADULT","OLDER_ADULT",[79],{"facility":13,"status":8,"city":80,"state":81,"zip":82,"country":83,"contacts":84,"geoPoint":91},"Boston","Massachusetts","02114","United States",[85,88],{"name":86,"role":87},"Heather Jameson, PhD","CONTACT",{"name":89,"role":90},"Hanna Gaggin, MD, MPH","PRINCIPAL_INVESTIGATOR",{"lat":92,"lon":93},42.35843,-71.05977,[95,99],{"name":96,"role":87,"phone":97,"email":98},"Abbie Macher, BS","617-643-6328","ajmacher@mgh.harvard.edu",{"name":100,"role":87,"phone":101,"email":102},"Laura Stockhausen, BS","617-724-1339","lstockhausen@mgh.harvard.edu",[104],{"name":89,"affiliation":13,"role":90},[106],{"pmid":107,"type":108,"citation":109},"34663746","DERIVED","Abboud A, Nguonly A, Bean A, Brown KJ, Chen RF, Dudzinski D, Fiseha N, Joice M, Kimaiyo D, Martin M, Taylor C, Wei K, Welch M, Zlotoff DA, Januzzi JL, Gaggin HK. Rationale and design of the preserved versus reduced ejection fraction biomarker registry and precision medicine database for ambulatory patients with heart failure (PREFER-HF) study. Open Heart. 2021 Oct;8(2):e001704. doi: 10.1136\u002Fopenhrt-2021-001704.",[],{"nct_id":4,"conditions":112,"biomarkers":119},[113,114,115,116,117,118],"Heart Disease Risk Factors","Heart Failure","Heart failure with mid range ejection fraction","Heart failure with normal ejection fraction","Heart failure with reduced ejection fraction","Right Heart Failure",[120,121],"NPPB wt Allele","N-Terminal Fragment Brain Natriuretic Protein",{"nct_id":4,"found":61,"summary":123,"prompt_version":133},{"design":124,"status":125,"heading":126,"summary":127,"follow_up":128,"word_count":129,"commitments":130,"compensation":131,"drugs_mentioned":132},"This is an observational study, meaning no specific interventions are being tested. It plans to include up to 3000 participants.","completed","Understanding Heart Failure: A Precision Medicine Registry","This study aims to better understand different types of heart failure and how they progress. Researchers will collect information like blood samples (including DNA), medical history, and imaging data from people with and without heart failure. The goal is to find better ways to match the right treatments to the right patients, which is called precision medicine. You may be able to join if you are 18 or older and have heart failure symptoms, along with specific blood test results (NT-proBNP over 125 pg\u002FmL or BNP over 35 pg\u002FmL) or heart catheterization findings. The main thing they will be looking for is major adverse cardiovascular events (like heart attacks or strokes) up to 60 months after the study ends.","Participants will be followed for major adverse cardiovascular events for up to 60 months after the study closure.",119,"Participants will provide baseline and one-year follow-up blood samples, including DNA. Clinical characteristics, medical history, and imaging data will also be collected.","Not stated in the trial record.",[],"v2"]