Recruiting

Heart Failure Phenotypes

Sponsor:

Massachusetts General Hospital

Code:

NCT03480633

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

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

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 Normal Ejection Fraction

Heart Failure With Reduced Ejection Fraction

Heart Failure, Right Sided

Heart Failure With Mid Range Ejection Fraction

Cardiovascular Risk Factor

Study ID

NCT03480633

Start date

Apr 7, 2016

Status verified date

Dec, 2025

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Oct 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

3000 participants

Anticipated

Interventions and Outcome Measures

Arms

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%.

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Abbie Macher, BS

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

Laura Stockhausen, BS

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

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Principal Investigator:

Hanna Gaggin, MD, MPH

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Aug 31, 2026

Last verified

Dec, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-08-31.