Biomechanical Precision Medicine Registry for Patients With and Without Heart Failure
Recruiting · NCT03480633 · Observational (researchers observe without assigning treatment) · Lead sponsor: Massachusetts General Hospital
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
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
Where it is running
1 location listed across 1 US state.
- Massachusetts General Hospital - Boston, Massachusetts, United States