Reversing Endothelial and Diastolic Dysfunction and Improving Collagen Turnover in Diastolic Heart Failure (PREDICT)
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ClinicalTrials.gov Identifier: NCT00293150 |
Recruitment Status
:
Terminated
(Lack of eligible patients)
First Posted
: February 17, 2006
Last Update Posted
: January 27, 2017
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Tracking Information | |||||
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First Submitted Date ICMJE | February 16, 2006 | ||||
First Posted Date ICMJE | February 17, 2006 | ||||
Last Update Posted Date | January 27, 2017 | ||||
Study Start Date ICMJE | September 2003 | ||||
Actual Primary Completion Date | September 2007 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Efficacy of eplerenone [ Time Frame: 9 months ] Improved diastolic function
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Original Primary Outcome Measures ICMJE | Not Provided | ||||
Change History | Complete list of historical versions of study NCT00293150 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
Degree of change [ Time Frame: 9 months ] degree of changes in natriuretic peptide production, endothelial function and collagen turnover
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Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Outcome Measures ICMJE | Not Provided | ||||
Original Other Outcome Measures ICMJE | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Reversing Endothelial and Diastolic Dysfunction and Improving Collagen Turnover in Diastolic Heart Failure | ||||
Official Title ICMJE | 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) | ||||
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 12.5 mg daily, that may titrate up to 25 mg daily) and/or 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. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 4 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Masking Description: Double Blind placebo vs eplerenone Primary Purpose: Treatment |
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Condition ICMJE | Diastolic Heart Failure | ||||
Intervention ICMJE | Drug: Eplerenone
Other Name: Inspra |
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Study Arms |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Terminated | ||||
Actual Enrollment ICMJE |
11 | ||||
Original Enrollment ICMJE |
80 | ||||
Actual Study Completion Date | September 2007 | ||||
Actual Primary Completion Date | September 2007 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:
Exclusion Criteria: The presence of any of the following will exclude a patient from study enrollment:
10. Use of spironolactone or amiloride within 30 days 11. Poorly controlled seating blood pressure at the time of drug initiation:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT00293150 | ||||
Other Study ID Numbers ICMJE | 6242 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | The Cleveland Clinic | ||||
Study Sponsor ICMJE | The Cleveland Clinic | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | The Cleveland Clinic | ||||
Verification Date | January 2017 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |