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