NCT03480633RecruitingAccepts Healthy Volunteers

Biomechanical Precision Medicine Registry for Patients With and Without Heart Failure

Massachusetts General Hospital

Start Date

4/7/2016

Completion Date

10/6/2027

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

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Conditions

Heart Failure With Normal Ejection FractionHeart Failure With Reduced Ejection FractionHeart Failure, Right SidedHeart Failure With Mid Range Ejection FractionCardiovascular Risk Factor

Locations

Massachusetts General Hospital

Boston, Massachusetts 02114

United States