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

This study has been terminated.
(Lack of eligible patients)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00293150
First Posted: February 17, 2006
Last Update Posted: January 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
The Cleveland Clinic
February 16, 2006
February 17, 2006
January 27, 2017
September 2003
September 2007   (Final data collection date for primary outcome measure)
Efficacy of eplerenone [ Time Frame: 9 months ]
Improved diastolic function
Not Provided
Complete list of historical versions of study NCT00293150 on ClinicalTrials.gov Archive Site
Degree of change [ Time Frame: 9 months ]
degree of changes in natriuretic peptide production, endothelial function and collagen turnover
Not Provided
Not Provided
Not Provided
 
Reversing Endothelial and Diastolic Dysfunction and Improving Collagen Turnover in Diastolic Heart Failure
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)
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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:
Double Blind placebo vs eplerenone
Primary Purpose: Treatment
Diastolic Heart Failure
Drug: Eplerenone
Other Name: Inspra
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
11
September 2007
September 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:

  1. 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)
  2. Age >/= 18 years of age
  3. 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.
  4. 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).
  5. Signed informed consent

Exclusion Criteria:

The presence of any of the following will exclude a patient from study enrollment:

  1. Unwilling to participate for the 9-month duration of the study
  2. Significant primary valvular, pulmonary or congenital cardiac disease believed to be the cause of dyspnea
  3. Life expectancy or planned cardiac transplantation <9 months
  4. History of hypertrophic obstructive cardiomyopathy
  5. Unstable angina or ischemia requiring revascularization
  6. 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
  7. Known hypersensitivity to spironolactone or eplerenone
  8. 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00293150
6242
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
The Cleveland Clinic
The Cleveland Clinic
Not Provided
Not Provided
The Cleveland Clinic
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP