Congestive Heart FailurePhase 3NCT00052026
Safety and Efficacy Study of Carvedilol to Treat Children With Congestive Heart Failure
A Phase 3 study testing carvedilol in people with Congestive Heart Failure, run by Shaddy, Robert, M.D. at 21 sites in United States.
Trial summary
The purpose of this study is to determine whether a new medicine, called carvedilol, improves symptoms and heart function in children who have congestive heart failure (diminished function of their heart muscle that pumps blood to the body). Read more about this study
- Who is it for?
- Ages 1 day to 17 years
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- carvedilol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 161 participants
- Where
- 21 sitesUnited States
- Study dates
- May 2000to Jul 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female children from birth through 17 years of age with chronic symptomatic CHF due to systemic ventricular systolic dysfunction who are receiving standard heart failure therapy will be eligible. Since adolescents with left ventricular dysfunction are very similar to adults with this disease, this study will focus recruitment in the prepubertal age group of children, including children from birth through Tanner Stage 3. The number of adolescents enrolled will be limited to approximately 10% of study enrollment. However, teenagers with single ventricles or morphologic right ventricles as systemic ventricles represent an important population that is unique to pediatric cardiology. The 10% limitation will only apply to teenagers who have dilated cardiomyopathies since these patients may be similar to young adults with dilated cardiomyopathies. Adolescents will be defined as Tanner Stage 4 through age 17.
- A diagnosis of CHF by NYHA Class II-IV (generally, children older than 5 years of age) or Ross' classification of CHF Class II-IV (12) (generally, children less than 5 years old) for at least 1 month (at least 2 weeks, for neonates) prior to screening.
- An estimated ejection fraction less than 40% in patients with systemic left ventricular dysfunction or qualitative evidence of a dilated ventricle with moderate systemic ventricular systolic dysfunction in patients with right ventricular or single ventricular physiology, documented within 4 weeks of randomization. Patients may be enrolled based on these criteria as determined by the site. However, all echocardiograms will be reviewed and interpreted by the Data Coordinating Center (DCC) at the University of Utah. Upon subsequent review by the DCC, if it is determined that either the ejection fraction is greater than or equal to 40% or the ventricular function is not moderate to severely decreased, patients will be enrolled. However, their data analysis will be based upon the findings from the DCC at the University of Utah.
- The etiology of the cardiomyopathy will include idiopathic dilated cardiomyopathy, post-viral myocarditis cardiomyopathy, anthracycline-induced cardiomyopathy, ischemic cardiomyopathies (e.g., Kawasaki's disease, repaired anomalous left coronary artery arising from the pulmonary artery, d-TGA s/p arterial switch), cardiomyopathies associated with single ventricle with ventricular systolic dysfunction, corrected transposition, etc. Excluded from enrollment will be dilated cardiomyopathies secondary to muscular dystrophies, hemoglobinopathies, HIV, carnitine deficiency, and systemic ventricular dysfunction due to ventricular outflow obstruction.
- Patients undergoing treatment for CHF with standard CHF therapy, such as diuretic, digoxin and ACE inhibitors. All patients should be receiving ACE inhibitors prior to enrollment in this study unless contraindicated or intolerant. If intolerance has been established, the patient must have been withdrawn from these drugs for at least one month prior to randomization. Other medications such as hydralazine, nitrates or amiodarone may also be used. Therapy with amiodarone should not have started or stopped within 2 months of randomization.
- All patients should be receiving diuretics prior to enrollment in this study unless contraindicated or intolerant. Patients must be in optimal fluid status prior to enrollment.
- Patients must be receiving a stable regimen of standard CHF medications for a period of at least one month (2 weeks in neonates) at the time of randomization into the study.
Who cannot join
- Patients with any of the following will be excluded from the study:
- NYHA or Ross' CHF Classification Class I (asymptomatic).
- Patients actively listed for transplantation at time of entry into the study or anticipated to undergo heart transplantation or corrective heart surgery during the 8 months following entry into the study. However, those patients in whom listing for transplantation is anticipated but may be waiting a long period of time (greater than 8 months), such as Status 2 patients, may be considered for enrollment in this 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 primary obstructive or severe regurgitative valvular disease, nondilated (restrictive) or hypertrophic cardiomyopathy, or significant systemic ventricular outflow obstruction.
- Dilated cardiomyopathies secondary to muscular dystrophies, hemoglobinopathies, HIV, carnitine deficiency, and systemic ventricular dysfunction due to ventricular outflow obstruction.
Show all 25Show fewer
- Active myocarditis.
- Unacceptable blood pressures and heart rates. Sitting (supine in infants) systolic blood pressure must be > 85 mm Hg in teens, > 75 mm Hg in school-aged children, and > 65 mm Hg in infants (12). Resting heart rate must be greater than the 2nd percentile for age (13).
- Renovascular hypertension or evidence of pulmonary hypertension (pulmonary vascular resistance index > 6 Wood units-m2) unresponsive to vasodilator agents such as oxygen, nitroprusside, or nitric oxide.
- History or current clinical evidence of moderate-to-severe obstructive pulmonary disease or reactive airway diseases (e.g., asthma) requiring therapy.
- Significant renal (serum creatinine >2.0), hepatic (serum AST and/or ALT > 3 times upper limit of normal), gastrointestinal, or biliary disorders that could impair absorption, metabolism, or excretion of orally administered medications.
- 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.
- Girls of child bearing potential who are pregnant, lactating, or sexually active and not taking adequate contraceptive precautions (e.g., IUD 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); investigational vaccines or biological agents (e.g., the monoclonal antibody Synagis), may be granted exceptions through consultation with the principal investigator and GlaxoSmithKline.
- History of drug sensitivity or allergic reaction to a-blockers or ß-blockers.
- Use of any of the following medications within two weeks of randomization:
- Monoamine oxidase (MAO) inhibitors
- Calcium entry blockers
- Alpha blockers, or labetalol
- Disopyramide, flecainide, encainide, moricizine, propafenone
- Intravenous ß-adrenergic agonists (including intravenous inotropes such as dobutamine) or intravenous vasodilator agents such as amrinone or milrinone
- Intravenous CHF medications (e.g., diuretics, digoxin)
- Treatment with b-adrenergic blockers, including sotalol or carvedilol within 2 months of randomization.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
C.S. Mott Children's Hospital
Ann Arbor, Michigan, 48109
University of Alabama
Birmingham, Alabama, 35249-6852
Children's Hospital, Boston
Boston, Massachusetts, 02115
Children's Memorial Hospital
Chicago, Illinois, 60614
UT Southwestern Medical Center
Dallas, Texas, 75235-7794
University of Colorado
Denver, Colorado, 80218
Children's Hospital of Michigan
Detroit, Michigan, 48201-2196
Texas Children's Hospital
Houston, Texas, 77030
Mattel Children's Hospital at UCLA
Los Angeles, California, 90025
Children's Hospital Los Angeles
Los Angeles, California, 90027
University of Miami
Miami, Florida, 33101
Vanderbilt Children's Hospital
Nashville, Tennessee, 37332
NYU Medical Center
New York, New York, 10016
Columbia University
New York, New York, 10032-1537
Stanford University
Palo Alto, California, 94303
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
University of Utah
Salt Lake City, Utah, 84132
Seattle Childrens Hospital and Regional Medical Center
Seattle, Washington, 98105
Washington University
St Louis, Missouri, 63110-1014
University of Southern Florida
St. Petersburg, Florida, 33701
About this study
Official title: A Multicenter, Placebo-Controlled, 8-Month Study of the Effect of Twice Daily Carvedilol in Children With Congestive Heart Failure Due to Systemic Ventricular Systolic Dysfunction
The purpose of this study is to determine whether a new medicine, called carvedilol, improves symptoms and heart function in children who have congestive heart failure (diminished function of their heart muscle that pumps blood to the body). To accomplish this, we will give carvedilol to some patients who have diminished heart function and congestive heart failure and see whether symptoms and heart function are better at the end of an 8 month period in those who received carvedilol compared to the other patients who did not receive carvedilol. We will be testing 2 different doses of carvedilol compared to no additional medicine.
Read the detailed description
Overactivity of the sympathetic nervous system is thought to contribute to the pathophysiology of congestive heart failure (CHF). Blockade of the sympathetic nervous system with β-adrenergic inhibitors could be expected to ameliorate these detrimental effects in a manner analogous to the effects of the angiotensin converting enzyme inhibitors on the overactive renin-angiotensin system.
Carvedilol may be superior to pure beta-blockers in the treatment of CHF through its mechanism of action of blocking not only β-receptors but also α-receptors, which would allow vasodilation to reduce the afterload on the failing heart. Since beta-blockers may initially produce a negative inotropic effect on the heart, long term treatment has been needed to show benefits of removal of the adrenergic stimulation. The investigators will monitor the safety and efficacy of carvedilol administration in children with chronic CHF due to systemic ventricular dysfunction.
- Conditions
- Congestive Heart Failure
- Being tested
- carvedilol, placebo
- Keywords
- Adolescent, Adrenergic alpha-Antagonists/therapeutic use, Adrenergic alpha-Antagonists/pharmacokinetics, Adrenergic alpha-Antagonists/administration & dosage, Adrenergic beta-Antagonists/therapeutic use, Adrenergic beta-Antagonists/pharmacokinetics, Adrenergic beta-Antagonists/administration & dosage, Age Factors, Carbazoles/therapeutic use, Carbazoles/administration & dosage, Child, Child, Preschool, Drug Administration Schedule, Female, Heart Failure, Congestive/etiology, Heart Failure, Congestive/drug therapy, Heart Failure, Congestive/blood, Human, Infant, Infant, Newborn
- Medical subject headings
- Heart Failure, Ventricular Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carvedilolDrug
Also called Coreg
low-dose carvedilol administered twice daily for 8 months
placeboDrug
administered twice daily for 8 months
carvedilolDrug
Also called Coreg
high-dose carvedilol administered twice daily for 8 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo Receives: Drug: placebo |
| 2 | Experimental | Low-dose carvedilol Receives: Drug: carvedilol |
| 3 | Experimental | high-dose carvedilol Receives: Drug: carvedilol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy variable is a CHF composite response.
Measured: 8 months
Secondary outcomes (1)
Selected individual components of the CHF composite of clinical outcomes
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2003 (estimated)
- Study startMay 2000
- Primary completionJun 2005
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaddy, Robert, M.D.
- Collaborators
- University of Utah
- Investigators
- Robert E. Shaddy, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00052026
- Sponsor's protocol ID
- SB 105517-321
- Status last verified
- Dec 2008
- First submitted
- 21 Jan 2003
- Last updated
- 25 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shaddy RE, Curtin EL, Sower B, Tani LY, Burr J, LaSalle B, Boucek MM, Mahony L, Hsu DT, Pahl E, Burch GH, Schlencker-Herceg R. The Pediatric Randomized Carvedilol Trial in Children with Heart Failure: rationale and design. Am Heart J. 2002 Sep;144(3):383-9. doi: 10.1067/mhj.2002.124402.
PubMed 12228773Boucek MM, Novick RJ, Bennett LE, Fiol B, Keck BM, Hosenpud JD. The Registry of the International Society of Heart and Lung Transplantation: first official pediatric report--1997. J Heart Lung Transplant. 1997 Dec;16(12):1189-206. No abstract available.
PubMed 9436131Gilbert EM, Anderson JL, Deitchman D, Yanowitz FG, O'Connell JB, Renlund DG, Bartholomew M, Mealey PC, Larrabee P, Bristow MR. Long-term beta-blocker vasodilator therapy improves cardiac function in idiopathic dilated cardiomyopathy: a double-blind, randomized study of bucindolol versus placebo. Am J Med. 1990 Mar;88(3):223-9. doi: 10.1016/0002-9343(90)90146-5.
PubMed 1968710Waagstein F, Bristow MR, Swedberg K, Camerini F, Fowler MB, Silver MA, Gilbert EM, Johnson MR, Goss FG, Hjalmarson A. Beneficial effects of metoprolol in idiopathic dilated cardiomyopathy. Metoprolol in Dilated Cardiomyopathy (MDC) Trial Study Group. Lancet. 1993 Dec 11;342(8885):1441-6. doi: 10.1016/0140-6736(93)92930-r.
PubMed 7902479Shaddy RE, Olsen SL, Bristow MR, Taylor DO, Bullock EA, Tani LY, Renlund DG. Efficacy and safety of metoprolol in the treatment of doxorubicin-induced cardiomyopathy in pediatric patients. Am Heart J. 1995 Jan;129(1):197-9. doi: 10.1016/0002-8703(95)90061-6. No abstract available.
PubMed 7817916Shaddy RE. Beta-blocker therapy in young children with congestive heart failure under consideration for heart transplantation. Am Heart J. 1998 Jul;136(1):19-21. doi: 10.1016/s0002-8703(98)70176-0.
PubMed 9665213Shaddy RE, Tani LY, Gidding SS, Pahl E, Orsmond GS, Gilbert EM, Lemes V. Beta-blocker treatment of dilated cardiomyopathy with congestive heart failure in children: a multi-institutional experience. J Heart Lung Transplant. 1999 Mar;18(3):269-74. doi: 10.1016/s1053-2498(98)00030-8.
PubMed 10328154Packer M, Bristow MR, Cohn JN, Colucci WS, Fowler MB, Gilbert EM, Shusterman NH. The effect of carvedilol on morbidity and mortality in patients with chronic heart failure. U.S. Carvedilol Heart Failure Study Group. N Engl J Med. 1996 May 23;334(21):1349-55. doi: 10.1056/NEJM199605233342101.
PubMed 8614419Bristow MR, Gilbert EM, Abraham WT, Adams KF, Fowler MB, Hershberger RE, Kubo SH, Narahara KA, Ingersoll H, Krueger S, Young S, Shusterman N. Carvedilol produces dose-related improvements in left ventricular function and survival in subjects with chronic heart failure. MOCHA Investigators. Circulation. 1996 Dec 1;94(11):2807-16. doi: 10.1161/01.cir.94.11.2807.
PubMed 8941106Olsen SL, Gilbert EM, Renlund DG, Taylor DO, Yanowitz FD, Bristow MR. Carvedilol improves left ventricular function and symptoms in chronic heart failure: a double-blind randomized study. J Am Coll Cardiol. 1995 May;25(6):1225-31. doi: 10.1016/0735-1097(95)00012-S.
PubMed 7722114Richards AM, Doughty R, Nicholls MG, Macmahon S, Ikram H, Sharpe N, Espiner EA, Frampton C, Yandle TG. Neurohumoral prediction of benefit from carvedilol in ischemic left ventricular dysfunction. Australia-New Zealand Heart Failure Group. Circulation. 1999 Feb 16;99(6):786-92. doi: 10.1161/01.cir.99.6.786.
PubMed 9989964Ross RD, Daniels SR, Schwartz DC, Hannon DW, Shukla R, Kaplan S. Plasma norepinephrine levels in infants and children with congestive heart failure. Am J Cardiol. 1987 Apr 1;59(8):911-4. doi: 10.1016/0002-9149(87)91118-0.
PubMed 3825955Bristow MR, O'Connell JB, Gilbert EM, French WJ, Leatherman G, Kantrowitz NE, Orie J, Smucker ML, Marshall G, Kelly P, et al. Dose-response of chronic beta-blocker treatment in heart failure from either idiopathic dilated or ischemic cardiomyopathy. Bucindolol Investigators. Circulation. 1994 Apr;89(4):1632-42. doi: 10.1161/01.cir.89.4.1632.
PubMed 7908610From Nadas AS, Fyler DC: Pediatric Cardiology. 3rd Ed. WB Saunders, Philadelphia, 1972.
From Harriet Lane Handbook, 14th Edition, page 132.
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Placebo-Controlled, 8-Month Study of the Effect of Twice Daily Carvedilol in Children With Congestive Heart Failure Due to Systemic Ventricular Systolic Dysfunction
- ClinicalTrials.gov ID
- NCT00052026
- Acronym / sponsor ID
- SB 105517-321
- Conditions
- Congestive Heart Failure
- Keywords
- Adolescent, Adrenergic alpha-Antagonists/therapeutic use, Adrenergic alpha-Antagonists/pharmacokinetics, Adrenergic alpha-Antagonists/administration & dosage, Adrenergic beta-Antagonists/therapeutic use, Adrenergic beta-Antagonists/pharmacokinetics, Adrenergic beta-Antagonists/administration & dosage, Age Factors
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Shaddy, Robert, M.D.
- Collaborators
- University of Utah
- Study start
- May 2000
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 23 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether a new medicine, called carvedilol, improves symptoms and heart function in children who have congestive heart failure (diminished function of their heart muscle that pumps blood to the body). To accomplish this, we will give carvedilol to some patients who have diminished heart function and congestive heart failure and see whether symptoms and heart function are better at the end of an 8 month period in those who received carvedilol compared to the other patients who did not receive carvedilol. We will be testing 2 different doses of carvedilol compared to no additional medicine.
Detailed description
Overactivity of the sympathetic nervous system is thought to contribute to the pathophysiology of congestive heart failure (CHF). Blockade of the sympathetic nervous system with β-adrenergic inhibitors could be expected to ameliorate these detrimental effects in a manner analogous to the effects of the angiotensin converting enzyme inhibitors on the overactive renin-angiotensin system.
Carvedilol may be superior to pure beta-blockers in the treatment of CHF through its mechanism of action of blocking not only β-receptors but also α-receptors, which would allow vasodilation to reduce the afterload on the failing heart. Since beta-blockers may initially produce a negative inotropic effect on the heart, long term treatment has been needed to show benefits of removal of the adrenergic stimulation. The investigators will monitor the safety and efficacy of carvedilol administration in children with chronic CHF due to systemic ventricular dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: placeboPlacebo |
| 2 | Experimental | Drug: carvedilolLow-dose carvedilol |
| 3 | Experimental | Drug: carvedilolhigh-dose carvedilol |
Who may qualify
- Ages
- 1 day to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Male or female children from birth through 17 years of age with chronic symptomatic CHF due to systemic ventricular systolic dysfunction who are receiving standard heart failure therapy will be eligible. Since adolescents with left ventricular dysfunction are very similar to adults with this disease, this study will focus recruitment in the prepubertal age group of children, including children from birth through Tanner Stage 3. The number of adolescents enrolled will be limited to approximately 10% of study enrollment. However, teenagers with single ventricles or morphologic right ventricles as systemic ventricles represent an important population that is unique to pediatric cardiology. The 10% limitation will only apply to teenagers who have dilated cardiomyopathies since these patients may be similar to young adults with dilated cardiomyopathies. Adolescents will be defined as Tanner Stage 4 through age 17.
- A diagnosis of CHF by NYHA Class II-IV (generally, children older than 5 years of age) or Ross' classification of CHF Class II-IV (12) (generally, children less than 5 years old) for at least 1 month (at least 2 weeks, for neonates) prior to screening.
- An estimated ejection fraction less than 40% in patients with systemic left ventricular dysfunction or qualitative evidence of a dilated ventricle with moderate systemic ventricular systolic dysfunction in patients with right ventricular or single ventricular physiology, documented within 4 weeks of randomization. Patients may be enrolled based on these criteria as determined by the site. However, all echocardiograms will be reviewed and interpreted by the Data Coordinating Center (DCC) at the University of Utah. Upon subsequent review by the DCC, if it is determined that either the ejection fraction is greater than or equal to 40% or the ventricular function is not moderate to severely decreased, patients will be enrolled. However, their data analysis will be based upon the findings from the DCC at the University of Utah.
- The etiology of the cardiomyopathy will include idiopathic dilated cardiomyopathy, post-viral myocarditis cardiomyopathy, anthracycline-induced cardiomyopathy, ischemic cardiomyopathies (e.g., Kawasaki's disease, repaired anomalous left coronary artery arising from the pulmonary artery, d-TGA s/p arterial switch), cardiomyopathies associated with single ventricle with ventricular systolic dysfunction, corrected transposition, etc. Excluded from enrollment will be dilated cardiomyopathies secondary to muscular dystrophies, hemoglobinopathies, HIV, carnitine deficiency, and systemic ventricular dysfunction due to ventricular outflow obstruction.
- Patients undergoing treatment for CHF with standard CHF therapy, such as diuretic, digoxin and ACE inhibitors. All patients should be receiving ACE inhibitors prior to enrollment in this study unless contraindicated or intolerant. If intolerance has been established, the patient must have been withdrawn from these drugs for at least one month prior to randomization. Other medications such as hydralazine, nitrates or amiodarone may also be used. Therapy with amiodarone should not have started or stopped within 2 months of randomization.
Key exclusion criteria (25 listed)
- NYHA or Ross' CHF Classification Class I (asymptomatic).
- Patients actively listed for transplantation at time of entry into the study or anticipated to undergo heart transplantation or corrective heart surgery during the 8 months following entry into the study. However, those patients in whom listing for transplantation is anticipated but may be waiting a long period of time (greater than 8 months), such as Status 2 patients, may be considered for enrollment in this 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 primary obstructive or severe regurgitative valvular disease, nondilated (restrictive) or hypertrophic cardiomyopathy, or significant systemic ventricular outflow obstruction.
- Dilated cardiomyopathies secondary to muscular dystrophies, hemoglobinopathies, HIV, carnitine deficiency, and systemic ventricular dysfunction due to ventricular outflow obstruction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carvedilolAlso: Coreglow-dose carvedilol administered twice daily for 8 months | Drug | 2 |
| placeboadministered twice daily for 8 months | Drug | 1 |
| carvedilolAlso: Coreghigh-dose carvedilol administered twice daily for 8 months | Drug | 3 |
Primary outcome
The primary efficacy variable is a CHF composite response.
Time frame: 8 months
1 secondary outcome
Selected individual components of the CHF composite of clinical outcomes
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Dec 2008.
- Background: PubMed 12228773Shaddy RE, Curtin EL, Sower B, Tani LY, Burr J, LaSalle B, Boucek MM, Mahony L, Hsu DT, Pahl E, Burch GH, Schlencker-Herceg R. The Pediatric Randomized Carvedilol Trial in Children with Heart Failure: rationale and design. Am Heart J. 2002 Sep;144(3):383-9. doi: 10.1067/mhj.2002.124402.
- Background: PubMed 9436131Boucek MM, Novick RJ, Bennett LE, Fiol B, Keck BM, Hosenpud JD. The Registry of the International Society of Heart and Lung Transplantation: first official pediatric report--1997. J Heart Lung Transplant. 1997 Dec;16(12):1189-206. No abstract available.
- Background: PubMed 1968710Gilbert EM, Anderson JL, Deitchman D, Yanowitz FG, O'Connell JB, Renlund DG, Bartholomew M, Mealey PC, Larrabee P, Bristow MR. Long-term beta-blocker vasodilator therapy improves cardiac function in idiopathic dilated cardiomyopathy: a double-blind, randomized study of bucindolol versus placebo. Am J Med. 1990 Mar;88(3):223-9. doi: 10.1016/0002-9343(90)90146-5.
- Background: PubMed 7902479Waagstein F, Bristow MR, Swedberg K, Camerini F, Fowler MB, Silver MA, Gilbert EM, Johnson MR, Goss FG, Hjalmarson A. Beneficial effects of metoprolol in idiopathic dilated cardiomyopathy. Metoprolol in Dilated Cardiomyopathy (MDC) Trial Study Group. Lancet. 1993 Dec 11;342(8885):1441-6. doi: 10.1016/0140-6736(93)92930-r.
- Background: PubMed 7817916Shaddy RE, Olsen SL, Bristow MR, Taylor DO, Bullock EA, Tani LY, Renlund DG. Efficacy and safety of metoprolol in the treatment of doxorubicin-induced cardiomyopathy in pediatric patients. Am Heart J. 1995 Jan;129(1):197-9. doi: 10.1016/0002-8703(95)90061-6. No abstract available.
- Background: PubMed 9665213Shaddy RE. Beta-blocker therapy in young children with congestive heart failure under consideration for heart transplantation. Am Heart J. 1998 Jul;136(1):19-21. doi: 10.1016/s0002-8703(98)70176-0.
- Background: PubMed 10328154Shaddy RE, Tani LY, Gidding SS, Pahl E, Orsmond GS, Gilbert EM, Lemes V. Beta-blocker treatment of dilated cardiomyopathy with congestive heart failure in children: a multi-institutional experience. J Heart Lung Transplant. 1999 Mar;18(3):269-74. doi: 10.1016/s1053-2498(98)00030-8.
- Background: PubMed 8614419Packer M, Bristow MR, Cohn JN, Colucci WS, Fowler MB, Gilbert EM, Shusterman NH. The effect of carvedilol on morbidity and mortality in patients with chronic heart failure. U.S. Carvedilol Heart Failure Study Group. N Engl J Med. 1996 May 23;334(21):1349-55. doi: 10.1056/NEJM199605233342101.
- Background: PubMed 8941106Bristow MR, Gilbert EM, Abraham WT, Adams KF, Fowler MB, Hershberger RE, Kubo SH, Narahara KA, Ingersoll H, Krueger S, Young S, Shusterman N. Carvedilol produces dose-related improvements in left ventricular function and survival in subjects with chronic heart failure. MOCHA Investigators. Circulation. 1996 Dec 1;94(11):2807-16. doi: 10.1161/01.cir.94.11.2807.
- Background: PubMed 7722114Olsen SL, Gilbert EM, Renlund DG, Taylor DO, Yanowitz FD, Bristow MR. Carvedilol improves left ventricular function and symptoms in chronic heart failure: a double-blind randomized study. J Am Coll Cardiol. 1995 May;25(6):1225-31. doi: 10.1016/0735-1097(95)00012-S.
- Background: PubMed 9989964Richards AM, Doughty R, Nicholls MG, Macmahon S, Ikram H, Sharpe N, Espiner EA, Frampton C, Yandle TG. Neurohumoral prediction of benefit from carvedilol in ischemic left ventricular dysfunction. Australia-New Zealand Heart Failure Group. Circulation. 1999 Feb 16;99(6):786-92. doi: 10.1161/01.cir.99.6.786.
- Background: PubMed 3825955Ross RD, Daniels SR, Schwartz DC, Hannon DW, Shukla R, Kaplan S. Plasma norepinephrine levels in infants and children with congestive heart failure. Am J Cardiol. 1987 Apr 1;59(8):911-4. doi: 10.1016/0002-9149(87)91118-0.
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Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert E. Shaddy, MD principal investigator
University of Utah
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing carvedilol in people with Congestive Heart Failure, run by Shaddy, Robert, M.D. at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary efficacy variable is a CHF composite response. (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00052026, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Dec 2008.