Reversing Endothelial and Diastolic Dysfunction and Improving Collagen Turnover in Diastolic Heart Failure (PREDICT)

Tracking Information
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; (submitted: January 24, 2017)	Efficacy of eplerenone [ Time Frame: 9 months ]; Improved diastolic function
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; (submitted: January 24, 2017)	Degree of change [ Time Frame: 9 months ]; degree of changes in natriuretic peptide production, endothelial function and collagen turnover
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.
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
Condition ICMJE	Diastolic Heart Failure
Intervention ICMJE	Drug: Eplerenone; Other Name: Inspra
Study Arms	Active Comparator: Eplerenone Eplerenone 25mg daily for 2 weeks Titrated to Eplerenone 50mg daily Intervention: Drug: Eplerenone; Placebo Comparator: Placebo Placebo dosed daily Intervention: Drug: Eplerenone
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Terminated
Actual Enrollment ICMJE; (submitted: January 24, 2017)	11
Original Enrollment ICMJE; (submitted: February 16, 2006)	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: Male or non-pregnant female (if female, either post-menopausal, or if of child-bearing potential, using adequate contraception e.g. hormonal or barrier methods, or surgically sterile, and not lactating); Age >/= 18 years of age; Present or prior history of symptoms of heart failure (dyspnea, fatigue) consistent with diagnosis of diastolic heart failure, following optimized medical therapy including blood pressure control with ACE inhibitors and/or beta-blockers for 2 weeks or over.; Echocardiographic evidence of preserved left ventricular systolic function (LVEF >/= 45%) and evidence of diastolic dysfunction (by transmitral inflow, pulmonary venous flow, color M-mode and/or tissue Doppler).; Signed informed consent Exclusion Criteria: The presence of any of the following will exclude a patient from study enrollment: Unwilling to participate for the 9-month duration of the study; Significant primary valvular, pulmonary or congenital cardiac disease believed to be the cause of dyspnea; Life expectancy or planned cardiac transplantation <9 months; History of hypertrophic obstructive cardiomyopathy; Unstable angina or ischemia requiring revascularization; Renal insufficiency (Cr >2.0 mg/dL in males and >1.8 mg/dl in females, or modified Cockcroft-Gault estimate of creatinine clearance <30 mL/min) at enrollment; Known hypersensitivity to spironolactone or eplerenone; Decompensated heart failure or clinical evidence of instability at the time of enrollment 9 History of hyperkalemia (>6.0 mg/dL) with spironolactone 10. Use of spironolactone or amiloride within 30 days 11. Poorly controlled seating blood pressure at the time of drug initiation: Systolic blood pressure >160 mmHg; and/or; Diastolic blood pressure >100 mmHg
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
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	Studies a U.S. FDA-regulated Drug Product: Yes Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement	Plan to Share IPD: No
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