Biomechanical Precision Medicine Registry for Patients With and Without Heart Failure (PREFER-HF)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Risk Factor; Heart Failure With Reduced Ejection Fraction; Heart Failure With Normal Ejection Fraction; Heart Failure, Right Sided; Heart Failure With Mid Range Ejection Fraction

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.

• Study Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Laura Stockhausen, BS; Phone Number: 617-724-1339; Email: lstockhausen@mgh.harvard.edu
• Study Contact Backup: Name: Abbie Macher, BS; Phone Number: 617-643-6328; Email: ajmacher@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Principal Investigator: Hanna Gaggin, MD, MPH
      • Contact: Heather Jameson, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Control; Defined as patients without a history of heart failure
Heart Failure w/NormalEjectionFraction; 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; Heart Failure with Reduced Ejection Fraction is defined as having a Left Ventricle Ejection Fraction of less than 50%.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Roche Diagnostics GmbH
• Investigators: Principal Investigator: Hanna Gaggin, MD, MPH, Massachusetts General Hospital

Publications and helpful links

General 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/openhrt-2021-001704.

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2016
• Primary Completion (Estimated): April 6, 2026
• Study Completion (Estimated): October 6, 2027

Study Registration Dates

• First Submitted: February 22, 2018
• First Submitted That Met QC Criteria: March 27, 2018
• First Posted (Actual): March 29, 2018

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Heart failure; Biomarkers; Pathophysiology; Precision medicine; High risk patients; Bioregistry; Heart failure etiology
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: 2016P000339

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No