Ignite Creation Date:
2024-05-06 @ 7:16 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05953831
Status:
WITHDRAWN
Last Update Posted:
2024-06-05
First Post:
2023-06-29
Brief Title:
Reverse Remodeling Effects of CDR132L in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction and Cardiac Hypertrophy
Sponsor:
Cardior Pharmaceuticals GmbH
Organization:
Cardior Pharmaceuticals GmbH
Study Overview
Official Title:
Phase 2 Multicenter Randomized Double-blind Placebo-controlled Safety and Efficacy Study of CDR132L on Reverse Cardiac Remodeling in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction and Cardiac Hypertrophy
Status:
WITHDRAWN
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Transfer of study responsibility and planning
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REMOD-REVERT
Brief Summary:
This is a Phase 2 multicenter randomized double-blind placebo-controlled study including approximately 130 randomized HF patients with heart failure with mildly reduced or preserved ejection fraction LVEF 45 to assess efficacy and safety of CDR132L on reverse remodeling In this study patients with HFpEF EF 50 or HFmrEF LVEF 45-49 will be included
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None