Cardiovascular Risk Factor, Heart Failure, Right Sided, Heart Failure With Mid Range Ejection Fraction, Heart Failure With Normal Ejection Fraction, Heart Failure With Reduced Ejection Fraction
Conditions
Keywords
Heart failure, Precision medicine, High risk patients, Pathophysiology, Bioregistry, Biomarkers, Heart failure etiology
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.
Interventions
None listed
Sponsors
Massachusetts General Hospital
Roche Diagnostics GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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: 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: 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. |
| 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: 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: 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 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. |
Countries
United States
Contacts
CONTACTAbbie Macher, BS
CONTACTLaura Stockhausen, BS
PRINCIPAL_INVESTIGATORHanna Gaggin, MD, MPH
Massachusetts General Hospital
Outcome results
None listed