Biomechanical Precision Medicine Registry for Patients With and Without Heart Failure (PREFER-HF)

Mass General Brigham

Status: Enrolling

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

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03480633

2016P000339

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

3,000 participants in 3 patient groups

Control

Description:

Defined as patients without a history of heart failure

Heart Failure w/NormalEjectionFraction

Description:

Heart Failure with Normal Ejection Fraction is defined as having a Left Ventricle Ejection Fraction of greater than or equal to 50%.

HeartFailure w/ReducedEjectionFraction

Description:

Heart Failure with Reduced Ejection Fraction is defined as having a Left Ventricle Ejection Fraction of less than 50%.