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Heart FailurePhase 4NCT00400582

A Pharmacogenomic Study of Candesartan in Heart Failure

A Phase 4 study testing Candesartan up to 32 mg daily in people with Heart Failure, run by Montreal Heart Institute at 1 site in Canada.

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

The purpose of this study is to evaluate the impact of genetic variations on the response to candesartan in patients with heart failure who are already treated with an ACE inhibitor. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
Candesartan up to 32 mg daily
How many people
300 participants
Where
1 siteCanada
Study dates
Nov 2006to Apr 2010
Phase
Phase 4
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
  • No healthy volunteers
  • Adult, Older adult

Principal Inclusion Criteria:

  1. Male or female > or = 18 years old.
  2. Symptomatic CHF corresponding to NYHA class II-IV symptoms for at least 4 weeks prior randomization.
  3. LVEF < or = 40%
  4. Treatment with an optimal and stable dose of ACE inhibitor for at least 4 weeks prior to enrolment in the study.

Principal Exclusion Criteria:

  1. Treatment with an ARB within 8 weeks prior to randomization.
  2. Known hypersensitivity to ARBs or ACE inhibitors.
  3. Creatinine clearance < 30 ml/min or serum creatinine > 221
  4. Current serum potassium > or = 5.0 mmol/L or a history of marked ACE inhibitor or ARB induced hyperkalemia.
  5. Known bilateral renal artery stenosis.
  6. Current symptomatic hypotension and/or systolic B.P. < 90 mmHg.
  7. Decompensated heart failure described as hospitalization or I.V. administration of medication in emergency room or heart failure clinic within 4 weeks
  8. Stroke, acute coronary syndrome, PCI within the last 4 weeks before randomization.
  9. Connective tissue disease or chronic inflammatory condition
  10. Acute inflammatory process such as an infection or gout attack in the last 2 weeks.
  11. Pregnant or lactating women or women of childbearing potential who are not protected from pregnancy by an accepted method of contraception.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8

Other trials in Canada

About this study

Official title: Effect of ACE Inhibitor Plus High Dose Candesartan on BNP and Inflammation in Patients With LV Dysfunction: Impact of Renin-angiotensin-aldosterone System Genetic Polymorphisms

The purpose of this study is to evaluate the impact of genetic variations on the response to candesartan in patients with heart failure who are already treated with an ACE inhibitor.

Conditions
Heart Failure
Being tested
Candesartan up to 32 mg daily
Keywords
Heart failure, Gene polymorphism, Candesartan, ACE inhibitors, BNP, Pharmacogenomics
Medical subject headings
Heart Failure

What participants receive

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

  • Candesartan up to 32 mg dailyDrug

    Also called Atacand

    Candesartan 4 to 32 mg daily

What is being measured

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

  1. BNP and NT-proBNP

    Measured: 16 weeks

Secondary outcomes (7)

  1. Blood pressure

    Measured: 16 weeks

  2. CRP

    Measured: 16 weeks

  3. Renin

    Measured: 16 weeks

  4. Aldosterone

    Measured: 16 weeks

  5. Insulin resistance/ glucose

    Measured: 16 weeks

  6. NYHA functional class

    Measured: 16 weeks

  7. Tolerability

    Measured: 16 weeks

Timeline

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

  1. First posted17 Nov 2006 (estimated)
  2. Study startNov 2006
  3. Primary completionApr 2010
  4. Study completionApr 2010

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 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00400582
Sponsor's protocol ID
MHI 06-890
Other IDs
D2454L00003
Status last verified
Jul 2011
First submitted
15 Nov 2006
Last updated
22 Jul 2011
Results posted
No
Data monitoring committee
No

Publications

  • de Denus S, Dube MP, Fouodjio R, Huynh T, LeBlanc MH, Lepage S, Sheppard R, Giannetti N, Lavoie J, Mansour A, Provost S, Normand V, Mongrain I, Langlois M, O'Meara E, Ducharme A, Racine N, Guertin MC, Turgeon J, Phillips MS, Rouleau JL, Tardif JC, White M; CANDIID II investigators. A prospective study of the impact of AGTR1 A1166C on the effects of candesartan in patients with heart failure. Pharmacogenomics. 2018 May;19(7):599-612. doi: 10.2217/pgs-2018-0004. Epub 2018 Apr 27.

    PubMed 29701105

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Candesartan up to 32 mg daily in people with Heart Failure, run by Montreal Heart Institute at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 22 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

BNP and NT-proBNP (time frame: 16 weeks). 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 NCT00400582, which also lists 1 linked publication.

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 22 Jul 2011.

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