NCT01912534

Valsartan for Attenuating Disease Evolution In Early Sarcomeric HCM

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 211 (actual)
• Sponsor: Carelon Research · Academic / Other
• Sex: All
• Age: 8 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to determine whether treatment with valsartan will have beneficial effect in early hypertrophic cardiomyopathy (HCM) by assessing many domains that reflect myocardial structure, function and biochemistry.

Detailed description

This is a multicenter, double-blind, placebo-controlled Phase II, randomized clinical trial to assess the safety and efficacy of valsartan in attenuating disease evolution in early HCM. Sarcomere mutation carriers with asymptomatic or mildly symptomatic overt disease (NYHA class I-II), and mutation carriers without left ventricular hypertrophy (LVH) will be studied.

Conditions

• Hypertrophic Cardiomyopathy

Interventions

Type	Name	Description
DRUG	Valsartan	40, 80 and 160 mg tablets of Valsartan
DRUG	Placebo	During Active Run-In, all patients take Valsartan. During maintenance, all patients are randomized to valsartan or placebo

Timeline

• Start date: 2014-03-01
• Primary completion: 2019-07-01
• Completion: 2019-07-01
• First posted: 2013-07-31
• Last updated: 2021-01-11

Locations

15 sites across 2 countries: United States, Canada