NCT00634400

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,268

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Mar 1999

Typical duration for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1999

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2003

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 13, 2008

Completed
Last Updated

January 25, 2011

Status Verified

January 1, 2011

Enrollment Period

4.2 years

First QC Date

March 7, 2008

Last Update Submit

January 24, 2011

Conditions

Congestive Heart Failure

Keywords

Congestive Heart FailureAtacandCandesartan

Outcome Measures

Primary Outcomes (1)

  • Cardiovascular mortality or hospitalisation due to congestive heart failure

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

Secondary Outcomes (1)

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

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

Study Arms (2)

1

ACTIVE COMPARATOR
Drug: Candesartan

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

CandesartanDRUG
Also known as: Atacand
1
PlaceboDRUG
2

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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.

    PMID: 37366061DERIVED

  • 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.

    PMID: 31982649DERIVED

  • 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.

    PMID: 29431256DERIVED

  • 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.

    PMID: 25326006DERIVED

  • 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.

    PMID: 24874200DERIVED

  • 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.

    PMID: 22093207DERIVED

  • 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.

    PMID: 19196892DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

candesartancandesartan cilexetil

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Chris Granger, MD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 7, 2008

First Posted

March 13, 2008

Study Start

March 1, 1999

Primary Completion

May 1, 2003

Study Completion

May 1, 2003

Last Updated

January 25, 2011

Record last verified: 2011-01