Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID03480633

Preserved vs. Reduced Ejection Fraction Biomarker Registry and Precision Medicine Database for Ambulatory Heart Failure Patients (PREFER-HF) Study

Led by Massachusetts General Hospital · Updated on 2025-12-09

3000

Participants Needed

1

Research Sites

78 weeks

Total Duration

On this page

Sponsors

M

Massachusetts General Hospital

Lead Sponsor

R

Roche Diagnostics GmbH

Collaborating Sponsor

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years and older
  • 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%
Not Eligible

You will not qualify if you...

  • End stage renal disease requiring dialysis

AI-Screening

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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

Trial Site Locations

Total: 1 location

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

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Research Team

A

Abbie Macher, BS

L

Laura Stockhausen, BS

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.

Andrew Abboud, Austin Nguonly, Asher Bean...

https://pubmed.ncbi.nlm.nih.gov/34663746