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PREDICT: Eplerenone in Reversing Endothelial and Diastolic Dysfunction and Improving Collagen Turnover in Diastolic Heart Failure

2014-08-27 03:46:04 | BioPortfolio

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.

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 Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Conditions

Diastolic Heart Failure

Intervention

eplerinone

Location

The Cleveland Clinic
Cleveland
Ohio
United States
44195

Status

Completed

Source

The Cleveland Clinic

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:46:04-0400

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Heart failure caused by abnormal myocardial relaxation during DIASTOLE leading to defective cardiac filling.

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