Candesartan in Heart Failure Assessment of Reduction in Mortality and Morbidity (CHARM Alternative)
Primary Purpose
Congestive Heart Failure
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Candesartan
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Congestive Heart Failure focused on measuring Congestive Heart Failure, Atacand, Candesartan
Eligibility Criteria
Inclusion Criteria:
- Male or female aged 18 or above
- Congestive Heart Failure with symptoms for more than 4 weeks before starting study
- Provision of informed consent
Exclusion Criteria:
- Current low blood pressure with symptoms
- Liver disease considered significant by the study doctor
- Pregnant or lactating females
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Cardiovascular mortality or hospitalisation due to congestive heart failure
Secondary Outcome Measures
Cardiovascular mortality or hospitalisation for management of congestive heart failure, or non fatal MI
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00634400
Brief Title
Candesartan in Heart Failure Assessment of Reduction in Mortality and Morbidity (CHARM Alternative)
Official Title
Candesartan in Heart Fail. Assess. of Reduction in Mortality & Morbidity. Candesartan in Patients With Heart Failure Who Are ACE Inhibitor Intolerant and Have Depressed Left Ventricular Systolic Function
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
March 1999 (undefined)
Primary Completion Date
May 2003 (Actual)
Study Completion Date
May 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A study to evaluate the effect of Atacand on patients with heart failure with depressed left ventricular function
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
Congestive Heart Failure, Atacand, Candesartan
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
6268 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Candesartan
Other Intervention Name(s)
Atacand
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Cardiovascular mortality or hospitalisation due to congestive heart failure
Time Frame
2, 4, 6 weeks, 6 months, every 4 months thereafter until 24 months
Secondary Outcome Measure Information:
Title
Cardiovascular mortality or hospitalisation for management of congestive heart failure, or non fatal MI
Time Frame
2, 4, 6 weeks, 6 months, every 4 months thereafter until 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria:
Male or female aged 18 or above
Congestive Heart Failure with symptoms for more than 4 weeks before starting study
Provision of informed consent
Exclusion Criteria:
Current low blood pressure with symptoms
Liver disease considered significant by the study doctor
Pregnant or lactating females
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris Granger, MD
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
31982649
Citation
Murray EJ, Claggett BL, Granger B, Solomon SD, Hernan MA. Adherence-adjustment in placebo-controlled randomized trials: An application to the candesartan in heart failure randomized trial. Contemp Clin Trials. 2020 Mar;90:105937. doi: 10.1016/j.cct.2020.105937. Epub 2020 Jan 23.
Results Reference
derived
PubMed Identifier
29431256
Citation
Lund LH, Claggett B, Liu J, Lam CS, Jhund PS, Rosano GM, Swedberg K, Yusuf S, Granger CB, Pfeffer MA, McMurray JJV, Solomon SD. Heart failure with mid-range ejection fraction in CHARM: characteristics, outcomes and effect of candesartan across the entire ejection fraction spectrum. Eur J Heart Fail. 2018 Aug;20(8):1230-1239. doi: 10.1002/ejhf.1149. Epub 2018 Feb 12.
Results Reference
derived
PubMed Identifier
25326006
Citation
Desai AS, Claggett B, Pfeffer MA, Bello N, Finn PV, Granger CB, McMurray JJ, Pocock S, Swedberg K, Yusuf S, Solomon SD. Influence of hospitalization for cardiovascular versus noncardiovascular reasons on subsequent mortality in patients with chronic heart failure across the spectrum of ejection fraction. Circ Heart Fail. 2014 Nov;7(6):895-902. doi: 10.1161/CIRCHEARTFAILURE.114.001567. Epub 2014 Oct 17.
Results Reference
derived
PubMed Identifier
24874200
Citation
Bello NA, Claggett B, Desai AS, McMurray JJ, Granger CB, Yusuf S, Swedberg K, Pfeffer MA, Solomon SD. Influence of previous heart failure hospitalization on cardiovascular events in patients with reduced and preserved ejection fraction. Circ Heart Fail. 2014 Jul;7(4):590-5. doi: 10.1161/CIRCHEARTFAILURE.113.001281. Epub 2014 May 29.
Results Reference
derived
PubMed Identifier
22093207
Citation
Ariti CA, Cleland JG, Pocock SJ, Pfeffer MA, Swedberg K, Granger CB, McMurray JJ, Michelson EL, Ostergren J, Yusuf S. Days alive and out of hospital and the patient journey in patients with heart failure: Insights from the candesartan in heart failure: assessment of reduction in mortality and morbidity (CHARM) program. Am Heart J. 2011 Nov;162(5):900-6. doi: 10.1016/j.ahj.2011.08.003. Epub 2011 Oct 7.
Results Reference
derived
PubMed Identifier
19196892
Citation
Preiss D, Zetterstrand S, McMurray JJ, Ostergren J, Michelson EL, Granger CB, Yusuf S, Swedberg K, Pfeffer MA, Gerstein HC, Sattar N; Candesartan in Heart Failure Assessment of Reduction in Mortality and Morbidity Investigators. Predictors of development of diabetes in patients with chronic heart failure in the Candesartan in Heart Failure Assessment of Reduction in Mortality and Morbidity (CHARM) program. Diabetes Care. 2009 May;32(5):915-20. doi: 10.2337/dc08-1709. Epub 2009 Feb 5.
Results Reference
derived
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Candesartan in Heart Failure Assessment of Reduction in Mortality and Morbidity (CHARM Alternative)
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