Biomechanical Precision Medicine Registry for Patients With and Without Heart Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Heart Failure With Normal Ejection Fraction, Heart Failure With Reduced Ejection Fraction, Heart Failure, Right Sided, Heart Failure With Mid Range Ejection Fraction. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Preserved vs. Reduced Ejection Fraction Biomarker Registry and Precision Medicine Database for Ambulatory Heart Failure Patients (PREFER-HF) Study
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.
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.
Primary outcome measures
- Major adverse cardiovascular events (MACE) [Time frame: Time from sample collection until the date of documented event up to 60 months after the study closure.]
Secondary outcome measures (7)
- Time to event: all-cause mortality [Time frame: Time from sample collection until the date of documented event up to 60 months after the study closure.]
- Time to event: cardiovascular mortality [Time frame: Time from sample collection until the date of documented event up to 60 months after the study closure.]
- Time to event: all-cause hospitalization [Time frame: Time from sample collection until the date of documented event up to 60 months after the study closure.]
- Time to event: cardiovascular hospitalization [Time frame: Time from sample collection until the date of documented event up to 60 months after the study closure.]
- Time to event: HF hospitalization [Time frame: Time from sample collection until the date of documented event up to 60 months after the study closure.]
- Time to event: Right-sided HF [Time frame: Time from sample collection until the date of documented event up to 60 months after the study closure.]
- Time to event: acute kidney injury [Time frame: Time from sample collection until the date of documented event up to 60 months after the study closure.]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Massachusetts General Hospital — Boston
Publications
- Abboud A, Nguonly A, Bean A, Brown KJ, Chen RF, Dudzinski D, Fiseha N, Joice M, Kimaiyo D, Martin M, Taylor C, Wei K, Welch M, Zlotoff DA, Januzzi JL, Gaggin HK. Rationale and design of the preserved versus reduced ejection fraction biomarker registry and precision medicine database for ambulatory patients with heart failure (PREFER-HF) study. Open Heart. 2021 Oct;8(2):e001704. doi: 10.1136/openhr PMID 34663746
Identifiers
NCT: NCT03480633 · 2016P000339