Effect of Carvedilol on Exercise Performance in Fontan Patients
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02946892 |
Recruitment Status :
Completed
First Posted : October 27, 2016
Results First Posted : January 22, 2021
Last Update Posted : January 22, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Single Ventricle Fontan | Drug: Carvedilol Drug: Placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 26 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Effect of Carvedilol on Exercise Performance in Fontan Patients |
Actual Study Start Date : | November 2016 |
Actual Primary Completion Date : | December 2019 |
Actual Study Completion Date : | January 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Carvedilol
Study participants will receive carvedilol for 12 weeks
|
Drug: Carvedilol
Carvedilol will be given for 12 weeks and then an exercise test will be performed
Other Name: Coreg |
Experimental: Placebo
Study participants will receive placebo (sugar pill) for 12 weeks
|
Drug: Placebo
Placebo will be given for 12 weeks and then an exercise test will be performed
Other Name: Carvedilol Placebo |
- Change in Peak Oxygen Uptake From Baseline Peak Oxygen Uptake [ Time Frame: on week 12 and week 30 of the study ]during exercise test on week 12 and week 30
- Change in Peak Heart Rate [ Time Frame: on week 12 and week 30 of the study ]during exercise test on week 12 and week 30
- Change in Oxygen Uptake at Anaerobic Threshold [ Time Frame: on week 12 and week 30 of the study ]during exercise test on week 12 and week 30

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Ages Eligible for Study: | 10 Years to 35 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Active and/or chronic protein losing enteropathy or plastic bronchitis (on inhaled medication to control the plastic bronchitis).
- Hypoalbuminemia defined as serum albumin <2.0g/dL
- Renal dysfunction defined as serum creatinine >2.0mg/dL
- Hepatic dysfunction defined as serum AST and/or ALT> 3 times upper limit of normal (approximately 120 IU/L however, will vary depending on age),
- Significant anemia or polycythemia defined as hemoglobin >18gm/dL or hemoglobin <7gm/dL
- Severely elevated serum BNP defined as BNP>300pg/ml

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02946892
United States, Texas | |
University of Texas Southwestern | |
Dallas, Texas, United States, 75390 |
Documents provided by Ryan Butts, University of Texas Southwestern Medical Center:
Responsible Party: | Ryan Butts, ASSOC PROFESSOR, PD-Cardiology, University of Texas Southwestern Medical Center |
ClinicalTrials.gov Identifier: | NCT02946892 |
Other Study ID Numbers: |
062016-101 |
First Posted: | October 27, 2016 Key Record Dates |
Results First Posted: | January 22, 2021 |
Last Update Posted: | January 22, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Univentricular Heart Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases Congenital Abnormalities Carvedilol Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents |
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