Completed
REMODELA Randomized, Double-Blind, Multi-Center,Study Evaluating the Effects of Eplerenone Versus Placebo on Ventricular Remodeling in Patient's With Left Ventricular Systolic Dysfunction (EF Less Than or Equal to 35%) and Mild to Moderate Heart Failure
What is being tested
Data Collection
Who is being recruted
Cardiovascular Diseases
+ Heart Diseases
+ Heart Failure
Over 21 Years
+5 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 4
Interventional
Study Start: April 2004
Summary
Principal SponsorPfizer's Upjohn has merged with Mylan to form Viatris Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 2004
Actual date on which the first participant was enrolled.The purpose of this study is to determine if eplerenone is effective in the treatment of mild to moderate heart failure
Official TitleA Randomized, Double-Blind, Multi-Center,Study Evaluating the Effects of Eplerenone Versus Placebo on Ventricular Remodeling in Patient's With Left Ventricular Systolic Dysfunction (EF Less Than or Equal to 35%) and Mild to Moderate Heart Failure
Principal SponsorPfizer's Upjohn has merged with Mylan to form Viatris Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
250 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 21 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Cardiovascular DiseasesHeart DiseasesHeart Failure
Criteria
3 inclusion criteria required to participate
Current symptoms consistent with mild to moderate heart failure (NYHA functional class II and III)
LVEF (left ventricular ejection fraction) of <35% by equilibrium-gated RVG at screening
Therapy with an angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) and beta-blocker (BB) (unless documented intolerance) for at least 3 months duration and at dose that has not been adjusted within the previous 4 weeks
2 exclusion criteria prevent from participating
Current decompensated heart failure or heart failure hospitalization or severe heart failure (NYHA functional class IV) within 6 months of screening
Use of eplerenone or spironolactone within 30 days of randomization or for more than 7 days within the previous 6 months
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 53 locations
Suspended
Pfizer Investigational Site
Castro Valley, United StatesOpen Pfizer Investigational Site in Google MapsSuspended
Pfizer Investigational Site
San Diego, United StatesSuspended
Pfizer Investigational Site
Santa Rosa, United StatesSuspended
Pfizer Investigational Site
Walnut Creek, United StatesCompleted53 Study Centers