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IMbria-101 to PRovide Optimal Ventricular Energetics in HCM (IMPROVE-HCM) Trial
This study is a double-blinded phase 2 clinical trial for a medication dedicated to treating patients with non-obstructive hypertrophic cardiomyopathy.
- Diagnosis of Hypertrophic Cardiomyopathy consistent with current US and European guidelines [including maximal end-diastolic left ventricular wall thickness ≥ 15 mm (or >13 by CMR in patients with a family history of HCM or who are positive for a pathogenic sarcomere gene mutation as measured by echo in the absence of other causative loading abnormalities capable of producing the magnitude of hypertrophy observed].
- No rest, and/or provokable (by exercise), Left Ventricular Outflow Tract obstruction (LVOTO), defined as peak LVOT gradient < 30 mmHg.
- Ability to perform an upright treadmill cardiopulmonary exercise test with an RER ≥ 1.1 at screening determined by CPET core lab reading.
- History of persistent uncontrolled systemic hypertension that in the judgement of the site investigator is likely responsible exclusively for the extent of left ventricular hypertrophy.
- Septal reduction procedure (surgical myectomy or alcohol septal ablation) within 6 months prior to screening.
- Moderate or severe aortic valve stenosis and/or intrinsic mitral valve disease with associated severe mitral regurgitation.
We expect that you will be in this research study for a maximum of 22 weeks. You will be asked to come to the study site for a maximum of 4 weeks for screening, a 12 week (maximum 14-week) treatment period and a 2-week (maximum 4-week) follow up period. A total of 185 mL (approx. 12 tablespoons) of blood will be collected during the study period.