Biomechanical Precision Medicine Registry for Patients With and Without Heart Failure

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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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

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br>Defined as patients without a history of heart failure | |
| Heart Failure w/NormalEjectionFraction<br>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<br>Heart Failure with Reduced Ejection Fraction is defined as having a Left Ventricle Ejection Fraction of less than 50%. | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to event: all-cause mortality | 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 from sample collection until the date of documented event up to 60 months after the study closure. | 
| Time to event: cardiovascular mortality | 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 from sample collection until the date of documented event up to 60 months after the study closure. | 
| Time to event: all-cause hospitalization | 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 from sample collection until the date of documented event up to 60 months after the study closure. | 
| Time to event: cardiovascular hospitalization | 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 from sample collection until the date of documented event up to 60 months after the study closure. | 
| Time to event: HF hospitalization | 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 from sample collection until the date of documented event up to 60 months after the study closure. | 
| Time to event: Right-sided HF | 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 from sample collection until the date of documented event up to 60 months after the study closure. | 
| Time to event: acute kidney injury | 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 from sample collection until the date of documented event up to 60 months after the study closure. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart failure, Precision medicine, High risk patients, Pathophysiology, Bioregistry, Biomarkers, Heart failure etiology