Clinical trial NCT03480633: Biomechanical Precision Medicine Registry for Patients With and Without Heart Failure
Official title: Preserved vs. Reduced Ejection Fraction Biomarker Registry and Precision Medicine Database for Ambulatory Heart Failure Patients (PREFER-HF) Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: 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
Keywords: Heart failure
Precision medicine
High risk patients
Pathophysiology
Bioregistry
Biomarkers
Heart failure etiology
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Roche Diagnostics GmbH
First posted: 2018-03-29
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be identified and screened in inpatient units, via medical records, outpatient clinics, primary physician or specialist schedules, and through Research Patient Data Registry (RPDR).

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.

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

Primary outcomes:
measure: Major adverse cardiovascular events (MACE)
timeFrame: Time from sample collection until the date of documented event up to 60 months after the study closure.
Secondary outcomes:
measure: Time to event: all-cause mortality
timeFrame: Time from sample collection until the date of documented event up to 60 months after the study closure.
measure: Time to event: cardiovascular mortality
timeFrame: Time from sample collection until the date of documented event up to 60 months after the study closure.
measure: Time to event: all-cause hospitalization
timeFrame: Time from sample collection until the date of documented event up to 60 months after the study closure.
measure: Time to event: cardiovascular hospitalization
timeFrame: Time from sample collection until the date of documented event up to 60 months after the study closure.
measure: Time to event: HF hospitalization
timeFrame: Time from sample collection until the date of documented event up to 60 months after the study closure.
measure: Time to event: Right-sided HF
timeFrame: Time from sample collection until the date of documented event up to 60 months after the study closure.
measure: Time to event: acute kidney injury
timeFrame: Time from sample collection until the date of documented event up to 60 months after the study closure.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Hanna Gaggin, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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/openhrt-2021-001704.