Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06655480
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-21
Brief Title:
Triple Combination Therapy ARNI SGLT2i MRA in Advanced HFpEF
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect on Clinical Status Structural and Functional Cardiac Parameters and Myocardial Fibrosis of Triple Combination Therapy with a Sodium-glucose Cotransporter 2 Inhibitor Angiotensin Receptorneprilysin Inhibitor and Mineralocorticoid Receptor Antagonist in Patients with Advanced HFpEF
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:
None
Brief Summary:
Patients with advanced heart failure with preserved ejection fraction HFpEF will be randomly assigned in open-label multicenter study to receive triple combination therapy with angiotensin receptorneprilysin inhibitor ARNI sodium-glucose cotransporter 2 inhibitor SGLTi mineralocorticoid receptor antagonist MRA or with individualized medical therapy SGLTi renin-angiotensin system inhibitor RASi angiotensin receptor blocker ARB or angiotensin-converting enzyme inhibitor ACE-I and will be treated for 52 weeks
Detailed Description:
HFpEF has a significant morbidity and mortality and the therapeutic options for HFpEF are limited According to the results of clinical HFpEF trials SGLTis and MRA can improve prognosis EMPEROR-preserved DELIVER FINEARTS-HF trials and ARNI can reduce the risk of hospitalization due to exacerbation of heart failure PARAGON-HF trial There is also clinical and experimental evidence of anti-inflammatory and antifibrotic effects in SGLTi MRA and ARNI However there are currently no randomized clinical trials evaluating the efficacy of the combination therapy with all these drugs in HFpEF The investigators suppose that triple combination therapy with ARNI SGLTi AMR in HFpEF will have a pronounced rapid and safe positive clinical and haemodynamic effect primarily through its effect on fibrosis and inflammation in patients with HFpEF
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