Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06532019
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-27
Brief Title:
Clinical Study of Active Intervention in High-risk HFpEF Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Randomized Multicenter Clinical Trial in Heart Failure Patients With Preserved Ejection Fraction HFpEF at Intermediate and High Risk of All-cause Death
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
Based on inclusion and exclusion criteria this experiment plans to include 924 Heart Failure with Preserved Ejection FractionHFpEF patients with increased risk of all-cause death The enrolled patients will divided into usual care group n462 and targeted intervention group n462 in a 11 ratio The usual care patients will receive routine heart failure treatment Patients in targeted intervention group on top of routine therapy for heart failure will receive further therapy targeting therapy to correct hypoalbuminemia anemia or hyponatremia and try to enhance medication to lower N-terminal pro brain natriuretic peptide NT-proBNP C-reactive proteinCRP New York Heart AssociationNYHA Classification to add diuretics for patients with higher right ventricular diametersRADsmultidiscipline intervention for patients complicating chronic obstructive pulmonary diseaseCOPD and actively reperfusion for ischemic HFpEF patients The incidence of all-cause death will be compared after 3 years follow-upThe primary endpoint is the occurrence of all-cause mortality events during the follow-up period
Detailed Description:
Our newly finished study developed and validated a risk prediction model for all-cause mortality in patients with HFpEF based on real-world data The nomogram prediction model included factors such as NT-proBNP albumin age NYHA class III-IV CRP RADs hemoglobin COPD hyponatremia and Percutaneous Coronary InterventionPCI Discharged HFpEF patients with scores 20037 were found to be associated with increased risk of all-cause death up to 3 years In this trial we sought to evaluate the impact of targeted risk factors intervention post-discharge in patients with with scores 20037 on all-cause death up to 3 years
Based on inclusion and exclusion criteriaWe will enroll 924 patients with HFpEF and scores 20037 The enrolled patients will divided into a usual care group n462 and targeted intervention group n462 in a 11 ratio The usual care group patients will receive routine heart failure treatment Patients in targeted intervention group on top of routine therapy for heart failure will receive further therapy targeting therapy to correct hypoalbuminemia anemia or hyponatremia and try to enhance medication to lower NT-proBNP CRP NYHA Classification to add diuretics for patients with higher RADs multidiscipline intervention for patients complicating COPD and actively reperfusion for ischemic HFpEF patients The primary endpoint is the occurrence of all-cause mortality events during the 3 years follow-up period
Based on inclusion and exclusion criteriaWe will enroll 924 patients with HFpEF and scores 20037 The enrolled patients will divided into a usual care group n462 and targeted intervention group n462 in a 11 ratio The usual care group patients will receive routine heart failure treatment Patients in targeted intervention group on top of routine therapy for heart failure will receive further therapy targeting therapy to correct hypoalbuminemia anemia or hyponatremia and try to enhance medication to lower NT-proBNP CRP NYHA Classification to add diuretics for patients with higher RADs multidiscipline intervention for patients complicating COPD and actively reperfusion for ischemic HFpEF patients The primary endpoint is the occurrence of all-cause mortality events during the 3 years follow-up period
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