Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-28 @ 10:08 PM
Study NCT ID:
NCT01912534
Status:
COMPLETED
Last Update Posted:
2021-01-11
First Post:
2013-06-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Valsartan for Attenuating Disease Evolution In Early Sarcomeric HCM
Sponsor:
Carelon Research
Organization:
Study Overview
Official Title:
Valsartan for Attenuating Disease Evolution In Early Sarcomeric HCM
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VANISH
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 5P50HL112349 | NIH | None | https://reporter.nih.gov/quic… | View |