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

Primary Purpose

Diastolic Heart Failure

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Eplerenone
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diastolic Heart Failure focused on measuring diastolic heart failure, heart failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Cleveland Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Eplerenone

Placebo

Arm Description

Eplerenone 25mg daily for 2 weeks Titrated to Eplerenone 50mg daily

Placebo dosed daily

Outcomes

Primary Outcome Measures

Efficacy of eplerenone
Improved diastolic function

Secondary Outcome Measures

Degree of change
degree of changes in natriuretic peptide production, endothelial function and collagen turnover

Full Information

First Posted
February 16, 2006
Last Updated
January 26, 2017
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT00293150
Brief Title
Reversing Endothelial and Diastolic Dysfunction and Improving Collagen Turnover in Diastolic Heart Failure
Acronym
PREDICT
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Why Stopped
Lack of eligible patients
Study Start Date
September 2003 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diastolic Heart Failure
Keywords
diastolic heart failure, heart failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
Double Blind placebo vs eplerenone
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Eplerenone
Arm Type
Active Comparator
Arm Description
Eplerenone 25mg daily for 2 weeks Titrated to Eplerenone 50mg daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo dosed daily
Intervention Type
Drug
Intervention Name(s)
Eplerenone
Other Intervention Name(s)
Inspra
Primary Outcome Measure Information:
Title
Efficacy of eplerenone
Description
Improved diastolic function
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Degree of change
Description
degree of changes in natriuretic peptide production, endothelial function and collagen turnover
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
The Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Reversing Endothelial and Diastolic Dysfunction and Improving Collagen Turnover in Diastolic Heart Failure

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