At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 46 enrolled
Drug / intervention
LCZ696 +1 moredrug
Likely dose
LCZ696 orally twice dailyAI-extracted
Key inclusion· 3
- ✓Diagnosed hypertrophic cardiomyopathy with left ventricular wall thickness ≥13 mm on echocardiogram
- ✓LVEF ≥50% on echocardiogram
- ✓NYHA Class II-III symptoms, OR asymptomatic/NYHA Class I with NT-proBNP >250 pg/ml AND peak VO2 ≤80% predicted
Key exclusion· 10
- ✕Resting or provokable LVOT gradient ≥30 mm Hg
- ✕Septal reduction procedure within 3 months of screening/baseline
- ✕History of atrial fibrillation within 6 months or ICD placement for secondary prevention
- ✕Peak VO2 >80% of predicted on cardiopulmonary exercise test
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-center, Randomized, Placebo-controlled Patient and Investigator-blinded Study to Explore the Efficacy of Oral Sacubitril/Valsartan in Adult Patients With Non-obstructive Hypertrophic Cardiomyopathy (nHCM)
In Brief
A Phase 2 clinical trial evaluating LCZ696 and Placebo for Cardiomyopathy, Hypertrophic. Completed, enrolled 46 participants across 18 sites in 6 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiomyopathy, Hypertrophic
CountriesGermany, Greece, South Korea, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedNov 2019
Enrollment StartJan 2020
Primary CompletionAug 2023
TodayJul 2026
First PostedNov 15, 2019
Enrollment StartJan 8, 2020
Primary CompletionAug 22, 2023
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 6.6 years ago
Interventions
LCZ696drug
LCZ696 orally twice daily
Placebodrug
placebo