Status:

RECRUITING

Biomechanical Precision Medicine Registry for Patients With and Without Heart Failure

Lead Sponsor:

Massachusetts General Hospital

Collaborating Sponsors:

Roche Diagnostics GmbH

Conditions:

Heart Failure With Normal Ejection Fraction

Heart Failure With Reduced Ejection Fraction

Eligibility:

All Genders

18+ years

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 h...

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, longitudin...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    April 7 2016

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ESTIMATED

    End Date :

    October 6 2027

    Estimated Enrollment :

    3000 Patients enrolled

    Trial Details

    Trial ID

    NCT03480633

    Start Date

    April 7 2016

    End Date

    October 6 2027

    Last Update

    December 9 2025

    Active Locations (1)

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    1

    Massachusetts General Hospital

    Boston, Massachusetts, United States, 02114