Ignite Creation Date:
2024-05-06 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04706429
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-29
First Post:
2021-01-11
Brief Title:
The Efficacy and Mechanism of Trientine in Patients With Hypertrophic Cardiomyopathy
Sponsor:
Manchester University NHS Foundation Trust
Organization:
Manchester University NHS Foundation Trust
Study Overview
Official Title:
A Randomised Double-blind Placebo-controlled Phase 2 Evaluation of the Efficacy and Mechanism of Trientine in Patients With Hypertrophic Cardiomyopathy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-11
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:
TEMPEST
Brief Summary:
This research study has been designed to test whether a drug called trientine dihydrochloride also called Cufence reduces heart muscle thickening improves exercise capacity improves heart function and reduces abnormal heart rhythms in patients with hypertrophic cardiomyopathy HCM The study is also assessing how trientine works in HCM Participants will be prescribed either trientine or placebo for a period of 12 months
Detailed Description:
HCM is the most common inherited cardiovascular disorder It is characterised by left ventricular LV myocardial hypertrophy and fibrosis Patients can experience symptoms of effort intolerance progressive heart failure and abnormal heart rhythms There are currently no treatments that alter the natural history of HCM Patients and the cardiovascular field have identified a critical need for clinical studies of drug therapies that target HCM pathophysiological mechanisms
Trientine dihydrochloride is a copper-chelating agent licensed for Wilson disease a genetic disorder of copper excretion in which patients exhibit a cardiac phenotype that mimics HCM Proof of concept has been established through an MRC-funded study to suggest that use of trientine may also be beneficial in HCM
Trientine dihydrochloride is a copper-chelating agent licensed for Wilson disease a genetic disorder of copper excretion in which patients exhibit a cardiac phenotype that mimics HCM Proof of concept has been established through an MRC-funded study to suggest that use of trientine may also be beneficial in HCM
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-002242-17 | EUDRACT_NUMBER | None | None |
| ISRCTN57145331 | REGISTRY | None | None |
| NIHR127575 | OTHER_GRANT | NIHR EME Programme | None |