Candesartan Cilexetil in Heart Failure Assessment of Reduction in Mortality and Morbidity (CHARM Preserved)
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
NCT00634712
Brief Title
Candesartan Cilexetil in Heart Failure Assessment of Reduction in Mortality and Morbidity (CHARM Preserved)
Official Title
Candesartan Cilexetil in Heart Failure Assessment of Reduction in Mortality and Morbidity. Clinical Study of Candesartan in Patients With Heart Failure and Preserved Left Ventricular Systolic Function
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
June 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 preserved 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
734 (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
, 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
Cardiovascular mortality or hospitalisation for management of congestive heart failure, or non fatal MI
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Dr Salim Yusuf
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
33301080
Citation
Shen L, Jhund PS, Anand IS, Carson PE, Desai AS, Granger CB, Kober L, Komajda M, McKelvie RS, Pfeffer MA, Solomon SD, Swedberg K, Zile MR, McMurray JJV. Developing and validating models to predict sudden death and pump failure death in patients with heart failure and preserved ejection fraction. Clin Res Cardiol. 2021 Aug;110(8):1234-1248. doi: 10.1007/s00392-020-01786-8. Epub 2020 Dec 10.
Results Reference
derived
PubMed Identifier
31370950
Citation
Tromp J, Shen L, Jhund PS, Anand IS, Carson PE, Desai AS, Granger CB, Komajda M, McKelvie RS, Pfeffer MA, Solomon SD, Kober L, Swedberg K, Zile MR, Pitt B, Lam CSP, McMurray JJV. Age-Related Characteristics and Outcomes of Patients With Heart Failure With Preserved Ejection Fraction. J Am Coll Cardiol. 2019 Aug 6;74(5):601-612. doi: 10.1016/j.jacc.2019.05.052.
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
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
Learn more about this trial
Candesartan Cilexetil in Heart Failure Assessment of Reduction in Mortality and Morbidity (CHARM Preserved)
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