Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06570473
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
Feasibility Trial for a Right Ventricular Failure Platform Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Feasibility Trial for the Canadian Right Ventricular AdaptiVE CRAVE Platform for Therapies Targeting Right Ventricular Failure
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CRAVE
Brief Summary:
The primary objective of the CRAVE feasibility trial is to assess the feasibility of conducting a larger CRAVE platform trial by performing a randomized trial of 30 participants with pulmonary hypertension and right ventricular dysfunction comparing empagliflozin or ranolazine plus standard of care to standard of care alone
Detailed Description:
This study is an investigator-initiated open label prospective multi-centre phase 2 randomized control trial This CRAVE feasibility trial will seek to establish the feasibility of a larger platform trial for testing multiple interventions in various domains to improve right ventricular function In this feasibility trial 30 participants with pulmonary hypertension and right heart failure with be randomized 111 to empagliflozin 10 mg daily standard of care ranolazine twice daily standard of care or standard of care alone Participant outcomes medical records review will be followed for 16 weeks after randomization
Study Oversight
Has Oversight DMC:
None
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?:
None