Effect of Carvedilol on Exercise Performance in Fontan Patients

NCT02946892 | Completed Phase 4 Results DMC

• 1 other identifier: 062016-101
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in Peak Oxygen Uptake From Baseline Peak Oxygen Uptake

  during exercise test on week 12 and week 30

  on week 12 and week 30 of the study

Secondary Outcomes (2)

• Change in Peak Heart Rate

  on week 12 and week 30 of the study

• Change in Oxygen Uptake at Anaerobic Threshold

  on week 12 and week 30 of the study

Study Arms (2)

Carvedilol

EXPERIMENTAL

Study participants will receive carvedilol for 12 weeks

Drug: Carvedilol

Placebo

EXPERIMENTAL

Study participants will receive placebo (sugar pill) for 12 weeks

Drug: Placebo

Interventions

Carvedilol DRUG

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

Also known as: Coreg

Carvedilol

Placebo DRUG

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

Also known as: Carvedilol Placebo

Placebo

Eligibility Criteria

• Age: 10 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Informed consent of parent(s) or legal guardian; informed consent or assent of subject as applicable.
• Male or female children between the ages of 10 and 35 years with congenital heart disease that has been palliated with a Fontan circulation.
• Ability of perform a maximal exercise test as defined by a respiratory exchange ratio (RER) greater than 1.0 at the time of maximal exercise

You may not qualify if:

• The use of beta blockers within 2 months of randomization
• Patients actively listed for transplantation at time of entry into the study or anticipated to undergo heart transplantation, interventional catheterization, or corrective cardiac surgery during the 7 months following entry into the study
• Sustained or symptomatic ventricular dysrhythmias uncontrolled by drug therapy or the use of an implantable defibrillator, and/or significant cardiac conduction defects, e.g., 2nd degree or 3rd degree AV block, or sick sinus syndrome, unless a functioning pacemaker is in place
• Uncorrected obstructive or severe regurgitant valve disease, nondilated cardiomyopathy, or significant systemic ventricular outflow obstruction
• Known renovascular hypertension or evidence of pulmonary hypertension (pulmonary vascular resistance \> 6 Wood units) unresponsive to vasodilator agents such as oxygen, nitroprusside, or nitric oxide
• History or current clinical evidence of moderate-to-severe fixed obstructive pulmonary disease or severe reactive airway diseases (e.g., asthma) requiring hospitalization within the past 2 years or patient currently using long-term inhaled bronchodilators
• Renal, hepatic, gastrointestinal, or biliary disorder that could impair absorption, metabolism or excretion of orally administered medication
• Concurrent terminal illness or other severe disease (e.g., active neoplasm) or other significant laboratory value(s) which, in the opinion of the investigator, could preclude participation or survival
• Endocrine disorders such as primary aldosteronism, pheochromocytoma, hyper- or hypothyroidism, insulin-dependent diabetes mellitus
• Unwillingness or inability to cooperate, or for the parents or guardians to give consent, or for the child to give assent, or any condition of sufficient severity to impair cooperation in the study
• Pregnancy or possible pregnancy at time of randomization, or female of child bearing potential who are lactating, or sexually active and not taking adequate contraceptive precautions (e.g., intrauterine device or oral contraceptives for 3 months prior to entry into the study)
• Use of an investigational drug within 30 days of randomization, or within 5 half-lives of the investigational drug (the longer period will apply)
• History of drug sensitivity or allergic reaction to alpha-blockers or ß-blockers
• Use of any of the following medications within two weeks of randomization: MAO inhibitors, Calcium channel blockers, alpha blockers, beta blockers, disopyramide, flecainide, encainide, moricizine, propafenone, sotalol, or beta adrenergic agonists
• Hospital admission for protein losing enteropathy or plastic bronchitis within 3 months of randomization

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• American Heart Association: collaborator

Study Sites (1)

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

Related Publications (1)

• Butts R, Atz AM, BaezHernandez N, Sutcliffe D, Reisch J, Mahony L. Carvedilol Does Not Improve Exercise Performance in Fontan Patients: Results of a Crossover Trial. Pediatr Cardiol. 2021 Apr;42(4):934-941. doi: 10.1007/s00246-021-02565-6. Epub 2021 Feb 14.

  PMID: 33585998 DERIVED

MeSH Terms

Conditions

Univentricular Heart

Interventions

Carvedilol

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring

Results Point of Contact

• Title: Ryan Butts
• Organization: UTSW

ryan.butts@utsouthwestern.edu

2144565822

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSOC PROFESSOR, PD-Cardiology

Study Record Dates

• First Submitted: September 23, 2016
• First Posted: October 27, 2016
• Study Start: November 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: January 1, 2020
• Last Updated: January 22, 2021
• Results First Posted: January 22, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)