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Chronic Heart FailurePhase 3SUPPORTNCT00417222

Supplemental Benefit of Angiotensin Receptor Blocker in Hypertensive Patients With Stable Heart Failure Using Olmesartan

A Phase 3 study testing olmesartan medoxomil in people with Chronic Heart Failure, run by Tohoku University at 1 site in Japan.

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 investigate whether an angiotensin II receptor blocker (olmesartan), in addition to conventional treatment, will reduce the mortality and morbidity in hypertensive patients with stable chronic heart failure. Read more about this study

Who is it for?
Ages 20 to 79 years
Conditions the study is for
Chronic Heart Failure
What is being tested?
olmesartan medoxomil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,145 participants
Where
1 siteJapan
Study dates
Nov 2006to Dec 2013
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 20 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who meet all of the following criteria.
  • Patients with NYHA class II through IV chronic heart failure.
  • Patients who have a history of hypertension or those who have antihypertensive medications.
  • Patients who are aged 20 years or older and less than 80 years at the entry.
  • Stable patients who have angiotensin converting enzyme inhibitor and/or beta-blocker.
  • Patients who do not have angiotensin II receptor blocker.

Who cannot join

  • Patients who have renal dysfunction (serum creatinine >=3.0mg/dL) or those who are receiving chronic hemodialysis.
  • History of drug hypersensitivity to olmesartan.
  • Patients who have severe liver dysfunction.
  • History of angioedema.
  • History of malignant tumor or life-threatening illness of poor prognosis.
  • Pregnant or possibly pregnant patients.
Show all 10Show fewer
  • Cardiovascular surgery within 6months prior to the date of the entry.
  • Acute myocardial infarction within 6 months prior to the date of the entry.
  • Percutaneous coronary intervention or stent implantation within 6 months prior to the date of the entry.
  • Other patients deemed unsuitable as subjects of the study by the treating physician.

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine

    Sendai, 980-8574

Other trials in Japan

About this study

Official title: Supplemental Benefit of Angiotensin II Receptor Blocker in Hypertensive Patients With Stable Heart Failure Using Olmesartan (SUPPORT Trial)

The purpose of this study is to investigate whether an angiotensin II receptor blocker (olmesartan), in addition to conventional treatment, will reduce the mortality and morbidity in hypertensive patients with stable chronic heart failure.

Being tested
olmesartan medoxomil

What participants receive

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

  • olmesartan medoxomilDrug

    5 to 40mg P.O. daily until the end of the study

Study groups in NCT00417222
Study groupRoleWhat they receive
Olmesartan medoxomilActive comparatorolmesartan medoxomil
Receives: Drug: olmesartan medoxomil
Standard therapyNo interventionStandard therapy

What is being measured

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

  1. A composite of the following outcomes 1) all-cause death 2) nonfatal acute myocardial infarction 3) nonfatal stroke 4) hospital admission due to congestive heart failure

    All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.

    Measured: by the end of the study

Secondary outcomes (13)

  1. cardiovascular death

    All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.

    Measured: by the end of the study

  2. death due to heart failure

    All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.

    Measured: by the end of the study

  3. sudden death

    All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.

    Measured: by the end of the study

  4. acute myocardial infarction

    All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.

    Measured: by the end of the study

  5. stroke

    All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.

    Measured: by the end of the study

  6. hospital admission from any cardiovascular reasons

    All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.

    Measured: by the end of the study

  7. fatal arrhythmia or appropriate ICD discharge

    All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.

    Measured: by the end of the study

  8. new-onset diabetes

    All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.

    Measured: by the end of the study

  9. development of renal failure

    All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.

    Measured: by the end of the study

  10. new-onset atrial fibrillation

    All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.

    Measured: by the end of the study

  11. a need to modify treatment procedures for heart failure

    All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.

    Measured: by the end of the study

  12. left ventricular ejection fraction

    All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.

    Measured: by the end of the study

  13. B-type natriuretic peptide

    All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.

    Measured: by the end of the study

Timeline

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

  1. First posted29 Dec 2006 (estimated)
  2. Study startNov 2006
  3. Primary completionMar 2013
  4. Study completionDec 2013

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
None (open label)
Enrolment
1,145 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00417222
Sponsor's protocol ID
2006-179
Acronym
SUPPORT
Status last verified
May 2014
First submitted
28 Dec 2006
Last updated
19 May 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Sakata Y, Shiba N, Takahashi J, Miyata S, Nochioka K, Miura M, Takada T, Saga C, Shinozaki T, Sugi M, Nakagawa M, Sekiguchi N, Komaru T, Kato A, Fukuchi M, Nozaki E, Hiramoto T, Inoue K, Goto T, Ohe M, Tamaki K, Ibayashi S, Ishide N, Maruyama Y, Tsuji I, Shimokawa H; SUPPORT Trial Investigators; SUPPORT Trial Investigators. Clinical impacts of additive use of olmesartan in hypertensive patients with chronic heart failure: the supplemental benefit of an angiotensin receptor blocker in hypertensive patients with stable heart failure using olmesartan (SUPPORT) trial. Eur Heart J. 2015 Apr 14;36(15):915-23. doi: 10.1093/eurheartj/ehu504. Epub 2015 Jan 30.

    PubMed 25637937

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing olmesartan medoxomil in people with Chronic Heart Failure, run by Tohoku University at 1 site in Japan.

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 6 inclusion and 10 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 19 May 2014. 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 Japan. 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 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?

A composite of the following outcomes 1) all-cause death 2) nonfatal acute myocardial infarction 3) nonfatal stroke 4) hospital admission due to congestive heart failure (time frame: by the end of the study). 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 NCT00417222, 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 19 May 2014.

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