Completed

Carvedilol and Ace Inhibitors for Improved Heart Function in Children with Moderate Heart Failure

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What is being tested

Carvedilol

Drug
Who is being recruted

Cardiovascular Diseases

+ Heart Diseases

From 3 Months to 17 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Phase 1
Interventional
See protocol details

Summary

Principal SponsorNational Center for Research Resources (NCRR)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

This study aims to explore the safety and effectiveness of using Carvedilol alongside Ace inhibitors in children with moderate heart failure. The goal is to improve the heart's pumping efficiency, specifically a measure called 'ejection fraction'. This research involves five hospitals, with Boston Children's Hospital leading the data review. The focus is on children who are already taking Ace inhibitors when they join the study. The hope is that this investigation may lead to improved care for children living with heart failure. During the study, participants receive Carvedilol in addition to their current Ace inhibitor treatment. Regular check-ups occur every 1-2 weeks, allowing the medical team to adjust the Carvedilol dosage as needed. The main goal is to observe changes in the heart's ejection fraction. Additionally, the study seeks to enhance the children's quality of life, exercise capacity, and reduce their symptoms, as reported in questionnaires.

NCT00004854
Principal SponsorNational Center for Research Resources (NCRR)
Last updated: June 24, 2005
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.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.

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.

From 3 Months to 17 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 Diseases

Criteria

4 inclusion criteria required to participate
Etiology of heart failure in Group 1 or Group 2
Moderate heart failure as evidenced by ventricular shortening fraction <= standard deviations below the mean, or ejection fraction <= 40% d) documented shortening fraction or ejection fraction that meet criteria for greater than 3 months
Standard medical therapy include ACE inhibitors plus or minus diuretics plus or minus digoxin; all efforts will made to maximize therapy prior to entry. Medication doses must be stable for 3 months prior to entry
Willingness to comply with followup testing

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 1 location

Washington University School of Medicine

St Louis, United StatesOpen Washington University School of Medicine in Google Maps
CompletedOne Study Center