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Biomechanical Precision Medicine Registry for Patients With and Without Heart Failure

Biomechanical Precision Medicine Registry for Patients With and Without Heart Failure

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

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.

Eligibility

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 details
    Heart Failure With Normal Ejection Fraction
    Heart Failure With Reduced Ejection Fraction
    Heart Failure
    Right Sided
    Heart Failure With Mid Range Ejection Fraction
    Cardiovascular Risk Factor

NCT03480633

Massachusetts General Hospital

10 June 2024

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