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Congestive Heart FailurePhase 3NCT00634400

Candesartan in Heart Failure Assessment of Reduction in Mortality and Morbidity (CHARM Alternative)

A Phase 3 study testing Candesartan in people with Congestive Heart Failure, run by AstraZeneca.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A study to evaluate the effect of Atacand on patients with heart failure with depressed left ventricular function Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Congestive Heart Failure
What is being tested?
Candesartan
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
6,268 participants
Where
No sites listed yet
Study dates
Mar 1999to May 2003
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 18 years and older
  • All sexes
  • Adult, Older adult

Who may be able to join

  • Male or female aged 18 or above
  • Congestive Heart Failure with symptoms for more than 4 weeks before starting study
  • Provision of informed consent

Who cannot join

  • Current low blood pressure with symptoms
  • Liver disease considered significant by the study doctor
  • Pregnant or lactating females

About this study

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

A study to evaluate the effect of Atacand on patients with heart failure with depressed left ventricular function

Being tested
Candesartan, Placebo
Keywords
Congestive Heart Failure, Atacand, Candesartan
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CandesartanDrug

    Also called Atacand

  • PlaceboDrug

Study groups in NCT00634400
Study groupRoleWhat they receive
1Active comparatorNot described
Receives: Drug: Candesartan
2Placebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardiovascular mortality or hospitalisation due to congestive heart failure

    Measured: 2, 4, 6 weeks, 6 months, every 4 months thereafter until 24 months

Secondary outcomes (1)

  1. Cardiovascular mortality or hospitalisation for management of congestive heart failure, or non fatal MI

    Measured: 2, 4, 6 weeks, 6 months, every 4 months thereafter until 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2008 (estimated)
  2. Study startMar 1999
  3. Primary completionMay 2003
  4. Study completionMay 2003

Resources

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
Double blind
Enrolment
6,268 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00634400
Sponsor's protocol ID
SH-AHS-0003
Other IDs
D2454C00003
Status last verified
Jan 2011
First submitted
7 Mar 2008
Last updated
25 Jan 2011
Results posted
No
Data monitoring committee
No

Publications

  • Kondo T, Dewan P, Anand IS, Desai AS, Packer M, Zile MR, Pfeffer MA, Solomon SD, Abraham WT, Shah SJ, Lam CSP, Jhund PS, McMurray JJV. Clinical Characteristics and Outcomes in Patients With Heart Failure: Are There Thresholds and Inflection Points in Left Ventricular Ejection Fraction and Thresholds Justifying a Clinical Classification? Circulation. 2023 Aug 29;148(9):732-749. doi: 10.1161/CIRCULATIONAHA.122.063642. Epub 2023 Jun 27.

    PubMed 37366061

  • 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.

    PubMed 31982649

  • 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.

    PubMed 29431256

  • 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.

    PubMed 25326006

  • 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.

    PubMed 24874200

  • 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.

    PubMed 22093207

  • 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.

    PubMed 19196892

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Candesartan in people with Congestive Heart Failure, run by AstraZeneca.

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 3 inclusion and 3 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 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.

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?

Cardiovascular mortality or hospitalisation due to congestive heart failure (time frame: 2, 4, 6 weeks, 6 months, every 4 months thereafter until 24 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 NCT00634400, which also lists 7 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 Jan 2011.

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