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Biomechanical Precision Medicine Registry for Patients With and Without Heart Failure
NCT03480633 · Massachusetts General Hospital
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Preserved vs. Reduced Ejection Fraction Biomarker Registry and Precision Medicine Database for Ambulatory Heart Failure Patients (PREFER-HF) Study
About this study
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.
Baseline 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.
Clinical 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.
Results 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.
Eligibility criteria
Inclusion criteria for patients with HF:
* 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/mL
* BNP \> 35 pg/mL
* Capillary wedge pressure ≥ 15 mmHg on right heart catheterization or CI \<2.8 L/min/m2
* LVEDP ≥ 15 mmHg
* Radiographic evidence of pulmonary edema
* Improvement in symptoms with diuretic initiation of increase
* CPET evidence of cardiac etiology of symptoms
HFpEF: LVEF ≥ 50% HFrEF: LVEF \<50%
Exclusion criteria (for all patients, including both those with HFpEF and HFrEF):
\- End stage renal disease on dialysis
Study design
Enrollment target: 3000 participants
Age groups: adult, older_adult
Timeline
Starts: 2016-04-07
Estimated completion: 2027-10-06
Last updated: 2025-12-09
Primary outcomes
- • Major adverse cardiovascular events (MACE) (Time from sample collection until the date of documented event up to 60 months after the study closure.)
Sponsor
Massachusetts General Hospital · other
With: Roche Diagnostics GmbH
Contacts & investigators
ContactAbbie Macher, BS · contact · ajmacher@mgh.harvard.edu · 617-643-6328
ContactLaura Stockhausen, BS · contact · lstockhausen@mgh.harvard.edu · 617-724-1339
InvestigatorHanna Gaggin, MD, MPH · principal_investigator, Massachusetts General Hospital
All locations (1)
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States