Biomechanical Precision Medicine Registry for Patients With and Without Heart Failure

NCT ID: NCT03480633

Last Updated: 2025-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-07

Study Completion Date

2027-10-06

Brief Summary

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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

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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.

Conditions

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Control

Defined as patients without a history of heart failure

No interventions assigned to this group

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%.

No interventions assigned to this group

HeartFailure w/ReducedEjectionFraction

Heart Failure with Reduced Ejection Fraction is defined as having a Left Ventricle Ejection Fraction of less than 50%.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

\- End stage renal disease on dialysis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Roche Diagnostics GmbH

INDUSTRY

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hanna Kim Gaggin

Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hanna Gaggin, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Abbie Macher, BS

Role: CONTACT

617-643-6328

Laura Stockhausen, BS

Role: CONTACT

617-724-1339

Facility Contacts

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Heather Jameson, PhD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 34663746 (View on PubMed)

Other Identifiers

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2016P000339

Identifier Type: -

Identifier Source: org_study_id

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