Biomarker and Precision Medicine Study for Adults With and Without Heart Failure
Including Different Heart Failure Types and Cardiomyopathies
Led by Massachusetts General Hospital · Updated on 2025-12-09
3000
Participants Needed
1
Research Sites
78 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are investigating different types of heart failure and cardiomyopathies, including amyloidosis, in adults aged 18 and older. This observational study aims to better understand how these heart conditions develop and progress over time by examining clinical features alongside proteomic, metabolomic, genomic, and imaging data. The goal is to improve precision medicine by matching the right treatments to the right patients to maximize benefits and reduce side effects.
Participants include those with and without heart failure, categorized into groups based on their left ventricular ejection fraction normal 50% or higher and reduced less than 50%. The study collects baseline and one-year follow-up blood samples, including DNA. Clinical data such as heart failure history, causes, other medical conditions, lab results, echocardiograms, images, and treatment details are also gathered.
During the study, researchers track major adverse cardiovascular events including death and hospitalizations related to heart failure and cardiovascular issues, as well as kidney injury. These outcomes are monitored over time up to 60 months after study closure. Participants undergo assessments at enrollment and after one year, providing valuable information to enhance understanding of heart failure subtypes and treatment effects.
CONDITIONS
Brief Title
Biomechanical Precision Medicine Registry for Patients With and Without Heart Failure
Research Team
A
Abbie Macher, BS
L
Laura Stockhausen, BS
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History of clinical symptoms consistent with heart failure
At least one supporting evidence of heart failure such as NT-proBNP > 125 pg/mL, BNP > 35 pg/mL, elevated pressure measurements, pulmonary edema on imaging, symptom improvement with diuretics, or cardiopulmonary exercise test showing cardiac cause
Heart failure with preserved ejection fraction defined as LVEF 60 50%
Heart failure with reduced ejection fraction defined as LVEF < 50%
You will not qualify if you...
End stage renal disease requiring dialysis
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Diagnostic Evaluation
Duration - At enrollment
Participants provide baseline blood samples including DNA and undergo clinical assessments to collect medical history, laboratory, echocardiographic data, and imaging.
1 visit (in-person)
Long-term Monitoring
Duration - Up to 60 months
Participants are observed over time to collect clinical outcomes including cardiovascular events, hospitalizations, and mortality up to 60 months after enrollment.
1 year follow-up visit and periodic assessments thereafter
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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Published Research Related To This Trial
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.