Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00293150
Status:
TERMINATED
Last Update Posted:
2017-01-27
First Post:
2006-02-16
Brief Title:
Reversing Endothelial and Diastolic Dysfunction and Improving Collagen Turnover in Diastolic Heart Failure
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Determine the Effectiveness of Eplerenone in Reversing Diastolic Dysfunction Improving Endothelial Function and Suppressing Natriuretic Peptides and Collagen Turnover in Patients With Diastolic Heart Failure PREDICT Study
Status:
TERMINATED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of eligible patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREDICT
Brief Summary:
The principle aim is to determine the efficacy of eplerenone in patients with diastolic heart failure to reverse cardiac remodeling and to improve diastolic function
Detailed Description:
The study will be a single center double-blind randomized parallel group trial enrolling a minimum of 80 patients designed to determine the efficacy of eplerenone in subjects with diastolic heart failure Prior to administration of study medication a medical history physical exam blood draw electrocardiogram 2D echocardiogram and cardiomyopathy questionnaire will be performed Subjects will then be randomized to receive either eplerenone 25 mg once daily or placebo for 2 weeks At the Week 2 visit all patients will be titrated up to the next dose 50 mg eplerenone once daily or placebo Each study arm will have 40 subjects who will participate for 9 months Follow-up assessments will be completed at 1 week 2 weeks 1 month 3 months 6 months and 9 months
Starting at the Month 1 visit any subjects with uncontrolled blood pressure will be administered add-on therapy of HCTZ starting dose of 125 mg daily that may titrate up to 25 mg daily andor amlodipine starting dose at 5 mg daily that may titrate up to 10 mg daily Any subject who receives add-on therapy must have their blood pressure checked within 2 weeks Uncontrolled blood pressure may be treated by either increasing the add-on therapy dose or increasing the add-on therapy regimen to include both add-on drugs Changes in add-on therapy require blood pressure checks within 2 weeks
Starting at the Month 1 visit any subjects with uncontrolled blood pressure will be administered add-on therapy of HCTZ starting dose of 125 mg daily that may titrate up to 25 mg daily andor amlodipine starting dose at 5 mg daily that may titrate up to 10 mg daily Any subject who receives add-on therapy must have their blood pressure checked within 2 weeks Uncontrolled blood pressure may be treated by either increasing the add-on therapy dose or increasing the add-on therapy regimen to include both add-on drugs Changes in add-on therapy require blood pressure checks within 2 weeks
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