Study of Efficacy of Oral Sacubitril/Valsartan in Adult Patients With Non-obstructive Hypertrophi… (NCT04164732) | Clinical Trial Compass
CompletedPhase 2
Study of Efficacy of Oral Sacubitril/Valsartan in Adult Patients With Non-obstructive Hypertrophic Cardiomyopathy
United States46 participantsStarted 2020-01-08
Plain-language summary
The purpose of this study was to determine if LCZ696 can improve functional capacity (via improved peak VO2) in non-obstructive hypertrophic cardiomyopathy (HCM) patient population over the course of 50 weeks of treatment.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Diagnosed with Hypertrophic Cardiomyopathy with a left ventricular wall thickness greater than or equal to 13mm as determined by the echocardiogram obtained during the screening/baseline period
* Left ventricular ejection fraction (LVEF) greater than or equal to 50% as determined by echocardiogram obtained during the screening/baseline period
* Symptoms consistent with New York Heart Association (NYHA) Class II-III heart failure by physician assessment, or asymptomatic/NYHA Class I patients with:
* NT-proBNP blood sample levels above 250 pg/ml and
* peak VO2 of less than or equal to 80% of predicted based on age and gender as determined by cardiopulmonary exercise testing
Exclusion Criteria:
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for ≥7 days after stopping study drug
* Patients with a resting or provokable left ventricular outflow tract gradient of greater than or equal to 30mm Hg
* Septal reduction procedure within 3 months of the screening/baseline visit
* History of atrial fibrillation within 6 months of the screening/baseline visit or placement of ICD for secondary prevention
* Patients with a peak VO2 on the screening/baseline cardiopulmonary exercise test of \> 80% of predicted based on age and gender
* Patients who require treatment with ACE inhibitors, angiotensin receptor blockers (ARBs), or re…
What they're measuring
1
Change From Baseline in Peak VO2 as Measured by Cardiopulmonary Exercise Test (CPET)