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NCT Number: NCT03480633

Biomechanical Precision Medicine Registry for Patients With and Without Heart Failure

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Location contact

Hanna Gaggin, MD, MPH

PRINCIPAL_INVESTIGATOR

Heather Jameson, PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

    MACE as defined by a combined end point of all-cause mortality and HF hospitalizations.

Secondary outcomes

  1. 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.

    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.

  2. 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.

    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.

  3. 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.

    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.

  4. 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.

    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.

  5. 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.

    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.

  6. 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.

    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.

  7. 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.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Abbie Macher, BS

CONTACT

[email protected]

617-643-6328

Laura Stockhausen, BS

CONTACT

[email protected]

617-724-1339

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Roche Diagnostics GmbH

Registry information

Official study title

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

Acronym: PREFER-HF

Important dates

Study start
2016
Primary completion
2026
Study completion
2027
First posted
Mar 29, 2018
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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