Study of Efficacy of Oral Sacubitril/Valsartan in Adult Patients With Non-obstructive Hypertrophic Cardiomyopathy

• Status: Recruiting
• Trial end date: 2023-05-04
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if LCZ696 is safe, tolerable and can improve exercise capacity (via improved peak VO2) in non-obstructive HCM patient population over the course of 50 weeks of treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: LCZ 696; Sacubitril and valsartan sodium hydrate drug combination; Valsartan

Criteria

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 renin inhibitors

• Known infiltrative or storage disorder such as Fabry disease, or amyloidosis

• Known or suspected symptomatic coronary artery diseases or evidence of prior myocardial infarction

• Systolic blood pressure of <100 mmHg or symptomatic hypotension during the screening/baseline period or treatment run-in period

• Contraindication to ARB administration or prior history of angioedema

• Persistent uncontrolled hypertension

Other protocol-defined inclusion/exclusion criteria may apply