Phase II randomized, placebo-controlled, double blind clinical trial of valsartan for attenuating disease evolution in early sarcomeric HCM - VANISH

ational Heart, Lung, and Blood Institute / National Institutes of Health0 sites150 target enrollmentDecember 16, 2015

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: ational Heart, Lung, and Blood Institute / National Institutes of Health
Enrollment: 150
Status: Active, not recruiting
Last Updated: 5 years ago

No summary available.

Registry

who.int

Start Date

December 16, 2015

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

ational Heart, Lung, and Blood Institute / National Institutes of Health

•5\.2 Inclusion Criteria
•1\.All subjects must have a Pathogenic or Likely Pathogenic HCM Sarcomere Mutation
•a.The following categories of mutations are considered acceptable for subjects who have previously undergone clinical genetic testing. If results are ambiguous or testing was performed at a lab other than those listed below, they will be reviewed by the Clinical Coordinating Center to determine eligibility.
•i.Laboratory for Molecular Medicine
•1\.Pathogenic
•2\.Likely Pathogenic
•ii.Transgenomics/ PGXHealth
•1\.Disease causing
•2\.Variant, likely disease\-causing
•3\.Published, disease\-causing mutation

•5\.3Subject Exclusion Criteria
•1\.Contraindication to ARB administration, including impaired renal function, hyperkalemia (serum K\>5\.0 mmol/L), prior history of angioedema
•2\.Medical conditions associated with increased collagen turnover that may confound interpretation of biomarkers of collagen synthesis (liver, pulmonary or renal fibrosis, inflammatory states, cancer, trauma or surgery within 6 months of enrollment)
•3\.Concomitant use of Spironolactone, Lithium, Aliskren, ARB or ACE\-inhibitors.. If these drugs are in active use but not necessary for medical care, they may be discontinued and baseline studies can be performed after a 2\-week washout period.
•4\.Pregnant or breastfeeding females
•5\.Females of childbearing potential with no effective contraceptive method (including abstinence)
•6\.Uncontrolled systemic HTN \[persistent SBP\>160 and/or DBP\>90 in adult or equivalent in children (e.g. SBP\>99th or DBP\>95th percentile for sex, age, and height centile based on the American Academy of Pediatrics normal values)
•7\.Obstructive physiology, defined by resting, Valsalva\-provoked or exercise\-induced gradient \>30mmHg within the past 24 months
•8\.Prior septal myectomy or alcohol septal ablation
•9\.Known, suspected, or symptomatic coronary artery disease or evidence of prior myocardial infarction based on symptoms or cardiac imaging