Heart Failure, CongestivePhase 3NCT00038077
Reversal of Ventricular Remodeling With Toprol-XL
A Phase 3 study testing Seloken ZOK/Toprol-XL in people with Heart Failure, Congestive, run by AstraZeneca at 44 sites in United States.
Trial summary
The purpose of this study is to determine whether treatment with Toprol-XL for 12 months in asymptomatic heart failure subjects will improve their heart structure and thus prevent the progression to symptomatic disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Congestive
- What is being tested?
- Seloken ZOK/Toprol-XL
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 44 sitesUnited States
- Study dates
- Aug 2001to Sep 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of stable asymptomatic heart failure.
- Documented ejection fraction less than 0.40.
- Must be able to comply with all study procedures.
Who cannot join
- Taken B-blocker therapy for longer than 1 week within 6 months prior to randomization.
- Have heart problems that would not allow B-blocker therapy.
- Receiving B-blockers therapy for any medical reason including topical B-blockers that might cause systemic absorption (e.g., glaucoma).
- Undergone certain heart surgeries, such as, prior heart transplant or cardiomyoplasty.
- Have certain heart diseases.
- Pregnant or breast feeding.
- Unlikely to survive.
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
United States44 sites
Study site
Albuquerque, New Mexico
Study site
Auburn, Maine
Study site
Augusta, Georgia
Study site
Baltimore, Maryland
Study site
Birmingham, Alabama
Study site
Boston, Massachusetts
Study site
Buffalo, New York
Study site
Burlington, North Carolina
Study site
Chesapeake, Virginia
Study site
Clearwater, Florida
Study site
Columbus, Ohio
Study site
East Syracuse, New York
Study site
Edgewood, Kentucky
Research Site
Farmington, Connecticut
Study site
Flourtown, Pennsylvania
Study site
Green Bay, Wisconsin
Study site
Indianapolis, Indiana
Study site
Jeffersonville, Indiana
Study site
Lincoln, Rhode Island
Study site
Little Rock, Arkansas
Study site
Los Angeles, California
Study site
Melbourne, Florida
Study site
Mobile, Alabama
Study site
New Orleans, Louisiana
Study site
New York, New York
Study site
Northridge, California
Study site
Oklahoma City, Oklahoma
Study site
Omaha, Nebraska
Study site
Philadelphia, Pennsylvania
Study site
Pittsburgh, Pennsylvania
Study site
Redondo Beach, California
Study site
Riverside, California
Study site
Roanoke, Virginia
Study site
Rochester, New York
Study site
Saint Charles, Missouri
Study site
Salisbury, Maryland
Study site
Salt Lake City, Utah
Study site
Shreveport, Louisiana
Study site
St Louis, Missouri
Study site
The Bronx, New York
Study site
Tyler, Texas
Study site
Vero Beach, Florida
Study site
Wakefield, Rhode Island
Study site
Williamsville, New York
About this study
The purpose of this study is to determine whether treatment with Toprol-XL for 12 months in asymptomatic heart failure subjects will improve their heart structure and thus prevent the progression to symptomatic disease.
- Conditions
- Heart Failure, Congestive
- Being tested
- Seloken ZOK/Toprol-XL, Placebo
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seloken ZOK/Toprol-XLDrug
Also called Toprol-XL
50 mg
Seloken ZOK/Toprol-XLDrug
Also called Toprol-XL
200 mg
PlaceboDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2002 (estimated)
- Study startAug 2001
- Primary completionSep 2003
- Study completionSep 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure, CongestiveStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Double blind
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00038077
- Sponsor's protocol ID
- 276
- Other IDs
- USMET0002
- Status last verified
- Nov 2010
- First submitted
- 28 May 2002
- Last updated
- 19 Nov 2010
- Results posted
- No
Publications
Colucci WS, Kolias TJ, Adams KF, Armstrong WF, Ghali JK, Gottlieb SS, Greenberg B, Klibaner MI, Kukin ML, Sugg JE; REVERT Study Group. Metoprolol reverses left ventricular remodeling in patients with asymptomatic systolic dysfunction: the REversal of VEntricular Remodeling with Toprol-XL (REVERT) trial. Circulation. 2007 Jul 3;116(1):49-56. doi: 10.1161/CIRCULATIONAHA.106.666016. Epub 2007 Jun 18.
PubMed 17576868
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reversal of Ventricular Remodeling With Toprol-XL
- ClinicalTrials.gov ID
- NCT00038077
- Acronym / sponsor ID
- 276
- Conditions
- Heart Failure, Congestive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2001
- Primary completion
- Sep 2003 (actual)
- Study completion
- Sep 2003 (actual)
- First posted
- 29 May 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether treatment with Toprol-XL for 12 months in asymptomatic heart failure subjects will improve their heart structure and thus prevent the progression to symptomatic disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of stable asymptomatic heart failure.
- Documented ejection fraction less than 0.40.
- Must be able to comply with all study procedures.
Key exclusion criteria (7 listed)
- Taken B-blocker therapy for longer than 1 week within 6 months prior to randomization.
- Have heart problems that would not allow B-blocker therapy.
- Receiving B-blockers therapy for any medical reason including topical B-blockers that might cause systemic absorption (e.g., glaucoma).
- Undergone certain heart surgeries, such as, prior heart transplant or cardiomyoplasty.
- Have certain heart diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Seloken ZOK/Toprol-XLAlso: Toprol-XL50 mg | Drug | – |
| Seloken ZOK/Toprol-XLAlso: Toprol-XL200 mg | Drug | – |
| Placebo | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2010.
- Derived from this study: PubMed 17576868Colucci WS, Kolias TJ, Adams KF, Armstrong WF, Ghali JK, Gottlieb SS, Greenberg B, Klibaner MI, Kukin ML, Sugg JE; REVERT Study Group. Metoprolol reverses left ventricular remodeling in patients with asymptomatic systolic dysfunction: the REversal of VEntricular Remodeling with Toprol-XL (REVERT) trial. Circulation. 2007 Jul 3;116(1):49-56. doi: 10.1161/CIRCULATIONAHA.106.666016. Epub 2007 Jun 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
44 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Seloken ZOK/Toprol-XL in people with Heart Failure, Congestive, run by AstraZeneca at 44 sites in United States.
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 7 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 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00038077, 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 Nov 2010.