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Effect of Carvedilol on Exercise Performance in Fontan Patients

NCT02946892 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2021-01-22

Study results available
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Summary

This study evaluates the effect of carvedilol in patients who have undergone a Fontan heart operation. All participants will receive carvedilol and placebo for 12 weeks. Exercise tests will be performed at the end of each 12 week period.

Conditions

  • Single Ventricle
  • Fontan

Interventions

DRUG

Carvedilol

Carvedilol will be given for 12 weeks and then an exercise test will be performed

DRUG

Placebo

Placebo will be given for 12 weeks and then an exercise test will be performed

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
10 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2019-12-31
Completion
2020-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02946892 on ClinicalTrials.gov