Biomechanical Precision Medicine Registry for Patients With and Without Heart Failure

NCT03480633 | Recruiting

• 1 other identifier: 2016P000339
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure With Reduced Ejection Fraction; Heart Failure, Right Sided; Heart Failure With Mid Range Ejection Fraction; Cardiovascular Risk Factor; Heart Failure With Normal Ejection Fraction

Keywords

Heart failure; Precision medicine; High risk patients; Pathophysiology; Bioregistry; Biomarkers; Heart failure etiology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Time to event: all-cause mortality

  Time from sample collection until the date of documented event up to 60 months after the study closure.

• Time to event: cardiovascular mortality

  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 from sample collection until the date of documented event up to 60 months after the study closure.

• Time to event: cardiovascular hospitalization

  Time from sample collection until the date of documented event up to 60 months after the study closure.

• Time to event: HF hospitalization

  Time from sample collection until the date of documented event up to 60 months after the study closure.

Study Arms (3)

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%.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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%

You may not qualify if:

• \- End stage renal disease on dialysis

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Roche Diagnostics GmbH: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 34663746 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be collected at baseline as well as at 1 year follow up. At both time points, a total blood volume of up to 50 mL will be collected using EDTA and serum tubes, while patients are seated. Samples will be spun at 1800 rpm and plasma aliquoted. Samples will be frozen immediately at -80 C. For patients who opt to participate in the genetic portion of this study, buffy coat aliquoting and processing will be executed using the same blood samples.

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Hanna Gaggin, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abbie Macher, BS

CONTACT

617-643-6328; ajmacher@mgh.harvard.edu

Laura Stockhausen, BS

CONTACT

617-724-1339; lstockhausen@mgh.harvard.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 50 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: March 29, 2018
• Study Start: April 7, 2016
• Primary Completion: April 6, 2026
• Study Completion (Estimated): October 6, 2027
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)