Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05747820
Status:
COMPLETED
Last Update Posted:
2024-02-13
First Post:
2023-02-08
Brief Title:
Multiparametric Assessment of Cardiac Congestion in Outpatient Worsening Heart Failure
Sponsor:
Corteria Pharmaceuticals
Organization:
Corteria Pharmaceuticals
Study Overview
Official Title:
Observational Study for Multiparametric Assessment of Cardiac Congestion in Outpatient Worsening Heart Failure EVOLUTION
Status:
COMPLETED
Status Verified Date:
2024-02
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:
EVOLUTION
Brief Summary:
This observational study is conducted to assess the evolution of multiple markers of congestion over 4 weeks after a worsening heart failure WHF event treated in an outpatient unit
Detailed Description:
This is a multicenter non-randomized observational study designed to assess the evolution of multiple markers physical echocardiographic and biomarkers of congestion in 40 patients with chronic heart failure CHF treated over 4 weeks with 40 to 120 mg daily oral furosemide after an event of WHF treated in an outpatient unit Patients at selected centers may participate in a telemetry ancillary study in which real-time continuous non-invasive measurements of physiologic parameters of heart failure will be obtained through use of a wearable medical telemetry device
Approximately 40 patients with CHF with reduced or mildly reduced left ventricular ejection fraction EF 50 who had an admission for WHF in the preceding 1-12 months and who develop symptoms of WHF over the week before presentation to an outpatient clinic will be enrolled Patients will attend five outpatient visits over the course of 4 weeks
At each visit the patients vital signs will be measured clinical assessments NYHA class jugular vein distension peripheral edema score pulmonary rales will be performed and blood samples for central assays will be obtained Detailed echocardiographic examination will be performed prior to enrolment in the first visit and at Visit 5
Biomarkers related to cardiac and renal function will be measured in blood and urine samples at each visit
Approximately 40 patients with CHF with reduced or mildly reduced left ventricular ejection fraction EF 50 who had an admission for WHF in the preceding 1-12 months and who develop symptoms of WHF over the week before presentation to an outpatient clinic will be enrolled Patients will attend five outpatient visits over the course of 4 weeks
At each visit the patients vital signs will be measured clinical assessments NYHA class jugular vein distension peripheral edema score pulmonary rales will be performed and blood samples for central assays will be obtained Detailed echocardiographic examination will be performed prior to enrolment in the first visit and at Visit 5
Biomarkers related to cardiac and renal function will be measured in blood and urine samples at each visit
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?:
None
Is an FDA AA801 Violation?:
None