Biomechanical Precision Medicine Registry for Patients With and Without Heart Failure

Recruiting

• Conditions: Heart Failure With Normal Ejection Fraction; Heart Failure With Mid Range Ejection Fraction; Heart Failure, Right Sided; Heart Failure With Reduced Ejection Fraction; Cardiovascular Risk Factor

• Registration Number: NCT03480633
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2016-04-07
• Study First Submitted: 2018-02-22
• Study First Submitted QC: 2018-03-27
• Study First Posted: 2018-03-29
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-31
• Last Update Posted: 2024-06-03
• Primary Completion: 2026-04-06
• Study Completion: 2027-10-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major adverse cardiovascular events (MACE)	Time from sample collection until the date of documented event up to 60 months after the study closure.	MACE as defined by a combined end point of all-cause mortality and HF hospitalizations.

Secondary Outcome Measures

Name	Time	Method
Time to event: acute kidney injury	Time from sample collection until the date of documented event up to 60 months after the study closure.	Medical records and phone follow-up with patients and/or their physicians will allow the investigators to ascertain vital status and any significant clinical events.
Time to event: all-cause mortality	Time from sample collection until the date of documented event up to 60 months after the study closure.	Medical records and phone follow-up with patients and/or their physicians will allow the investigators to ascertain vital status and any significant clinical events.
Time to event: cardiovascular hospitalization	Time from sample collection until the date of documented event up to 60 months after the study closure.	Medical records and phone follow-up with patients and/or their physicians will allow the investigators to ascertain vital status and any significant clinical events.
Time to event: Right-sided HF	Time from sample collection until the date of documented event up to 60 months after the study closure.	Medical records and phone follow-up with patients and/or their physicians will allow the investigators to ascertain vital status and any significant clinical events.
Time to event: cardiovascular mortality	Time from sample collection until the date of documented event up to 60 months after the study closure.	Medical records and phone follow-up with patients and/or their physicians will allow the investigators to ascertain vital status and any significant clinical events.
Time to event: all-cause hospitalization	Time from sample collection until the date of documented event up to 60 months after the study closure.	Medical records and phone follow-up with patients and/or their physicians will allow the investigators to ascertain vital status and any significant clinical events.
Time to event: HF hospitalization	Time from sample collection until the date of documented event up to 60 months after the study closure.	Medical records and phone follow-up with patients and/or their physicians will allow the investigators to ascertain vital status and any significant clinical events.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States