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

NCT00293150 | Terminated Phase 4 FDA Drug

• 1 other identifier: 6242
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Diastolic Heart Failure

Keywords

diastolic heart failure; heart failure

Outcome Measures

Primary Outcomes (1)

• Efficacy of eplerenone

  Improved diastolic function

  9 months

Secondary Outcomes (1)

• Degree of change

  9 months

Study Arms (2)

Eplerenone

ACTIVE COMPARATOR

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

Drug: Eplerenone

Placebo

PLACEBO COMPARATOR

Placebo dosed daily

Drug: Eplerenone

Interventions

Eplerenone DRUG

Also known as: Inspra

Eplerenone; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• \. 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Heart Failure, Diastolic; Heart Failure

Interventions

Eplerenone

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double Blind placebo vs eplerenone
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2006
• First Posted: February 17, 2006
• Study Start: September 1, 2003
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: January 27, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)