CardiomyopathyPhase 4NCT00806390
Prevention of Anthracycline or Trastuzumab Induced Cardiomyopathy by Metoprolol
A Phase 4 study testing Metoprolol in people with Cardiomyopathy, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
The primary objective of this study is to investigate whether giving prophylactic metoprolol prior to and during anthracycline or trastuzumab therapy will decrease the incidence of anthracycline-induced cardiomyopathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiomyopathy
- What is being tested?
- Metoprolol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Jun 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients must have confirmed malignancy for which standard regimens of anthracyclines or trastuzumab are being offered as treatment at the University of Maryland Greenebaum Cancer Center. Patients must either receive 4 cycles of anthracycline for a total dose of 240 mg/m2 or six cycles of TAC for a total dose of 300 mg/m2 or trastuzumab.
- Age > 18 years
- Ability to understand and willingness to sign a written informed consent document.
- Women of childbearing potential may participate in this study only if they have a negative pregnancy test and agree not to become pregnant during the study. Woman of childbearing potential must use an effective method of birth control such as hormonal contraceptives (oral and implant) condoms, diaphragms, spermicidal foam or jelly, surgical (hysterectomy or tubal ligation) or intrauterine device.
Who cannot join
- Patients who have established dilated or restrictive cardiomyopathy with EF < 40 %.
- Patients with severe mitral or aortic valve disease (valve area <1cm squared).
- Patients who have any contraindication to metoprolol, in particular bradycardia with HR < 50, or severe reactive pulmonary disease such as asthma. Patients who take mibefradil or psychiatric drugs (such as phenothiazines including chlorpromazine and thioridazine) will also be excluded from the study as they have serious interactions with beta-blockers
- Patients who have untreated thyroid function disorder.
- Pregnant and nursing women are excluded from this study because of potential risk for adverse events to the fetus.
- Patients with any impediment to swallowing tablets would be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: GCC0766: Prevention of Anthracycline or Trastuzumab Induced Cardiomyopathy by Metoprolol
The primary objective of this study is to investigate whether giving prophylactic metoprolol prior to and during anthracycline or trastuzumab therapy will decrease the incidence of anthracycline-induced cardiomyopathy. Patients are randomized to receive metoprolol or no treatment prior to anthracycline or trastuzumab treatment. The ejection fraction, as measured by nuclear ventriculography is measured before and after treatment.
Read the detailed description
This is a randomized, controlled exploration. Consent will be obtained from patients receiving care for cancer with anthracycline or trastuzumab at the University Of Maryland Greenebaum Cancer Center prior to initiation of anthracycline or trastuzumab treatment during the initial oncology visit.
Patients will be evaluated in the initial consultation in the oncology clinic during which time consent will be obtained, and any patient with bradycardia (HR less than 50) or other contraindication will be excluded from the study. The patients will be randomly assigned to metoprolol vs. control groups during this initial visit. Individuals in the control group will not receive any study drug where as those in the metoprolol group will be given prophylactic metoprolol prior to initiation of anthracycline or trastuzumab treatment. Metoprolol tartrate will be provided to each patient randomized to the metoprolol group.
Also at the time of the initial consultation, a baseline MUGA will be obtained for evaluation of left ventricular ejection fraction. Additionally, a post-treatment MUGA will be obtained after the final course of chemotherapy. Lastly, also at the initial visit, one vial of blood will be obtained from each patient to test for genetic polymorphisms, as described in the background section, which may contribute to the response to beta blockade in the prevention of anthracycline or trastuzumab induced cardiomyopathy.
Each participant in the metoprolol group will be started on 25 mg of metoprolol tartrate twice a day prior to initiation of the anthracycline or trastuzumab. After one week, this dose will be increased to 50 mg twice daily, if tolerated. Prior to increasing the dose, the patients will be seen in the cardiology research clinic by the study doctor and evaluated for side effects. After another week the dose will again be increased to 100 mg twice daily. The dose can be decreased at any time if side effects occur such as bradycardia with HR less than 50 or hypotension with SBP less than 90. The beta blocker will be held for two days prior to the post-treatment MUGA so as not to acutely affect heart rate, as a decrease in heart rate would be expected to increase EF14. Abrupt cessation of metoprolol tartrate will not lead to withdrawal of beta-blockade. This study will end with the post-treatment MUGA. The primary end point of this study will be the change in EF before and after anthracycline or trastuzumab treatment. A pill diary will be maintained to document compliance of study medication.
- Conditions
- Cardiomyopathy
- Being tested
- Metoprolol
- Keywords
- ejection fraction, anthracyclines, beta-adrenergic blockade, Patients receiving anthracyclines
- Medical subject headings
- Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetoprololDrug
Metroprolol tartrate titrated up
| Study group | Role | What they receive |
|---|---|---|
| Metoprolol | Active comparator | Receiving metoprolol Receives: Drug: Metoprolol |
| Control | No intervention | Not receiving metoprolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ejection Fraction by MUGA
Because of the inability to enroll an adequate number of patients, (only 15 out of a planned 50) no data analysis was collected or performed.
Measured: Pre and post anthracycline treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2008 (estimated)
- Study startJul 2008
- Primary completionJun 2012
- Study completionJun 2012
Why it stopped: Poor enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CardiomyopathyStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Gottlieb, University of Maryland, Baltimore
- Investigators
- Stephen S Gottlieb, MD, Principal investigator, University of Maryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00806390
- Sponsor's protocol ID
- HP-00040965
- Status last verified
- Feb 2022
- First submitted
- 8 Dec 2008
- Last updated
- 25 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GCC0766: Prevention of Anthracycline or Trastuzumab Induced Cardiomyopathy by Metoprolol
- ClinicalTrials.gov ID
- NCT00806390
- Acronym / sponsor ID
- HP-00040965
- Conditions
- Cardiomyopathy
- Keywords
- ejection fraction, anthracyclines, beta-adrenergic blockade, Patients receiving anthracyclines
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor enrollment
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 10 Dec 2008 (estimated)
- Results
- Posted 22 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to investigate whether giving prophylactic metoprolol prior to and during anthracycline or trastuzumab therapy will decrease the incidence of anthracycline-induced cardiomyopathy. Patients are randomized to receive metoprolol or no treatment prior to anthracycline or trastuzumab treatment. The ejection fraction, as measured by nuclear ventriculography is measured before and after treatment.
Detailed description
This is a randomized, controlled exploration. Consent will be obtained from patients receiving care for cancer with anthracycline or trastuzumab at the University Of Maryland Greenebaum Cancer Center prior to initiation of anthracycline or trastuzumab treatment during the initial oncology visit.
Patients will be evaluated in the initial consultation in the oncology clinic during which time consent will be obtained, and any patient with bradycardia (HR less than 50) or other contraindication will be excluded from the study. The patients will be randomly assigned to metoprolol vs. control groups during this initial visit. Individuals in the control group will not receive any study drug where as those in the metoprolol group will be given prophylactic metoprolol prior to initiation of anthracycline or trastuzumab treatment. Metoprolol tartrate will be provided to each patient randomized to the metoprolol group.
Also at the time of the initial consultation, a baseline MUGA will be obtained for evaluation of left ventricular ejection fraction. Additionally, a post-treatment MUGA will be obtained after the final course of chemotherapy. Lastly, also at the initial visit, one vial of blood will be obtained from each patient to test for genetic polymorphisms, as described in the background section, which may contribute to the response to beta blockade in the prevention of anthracycline or trastuzumab induced cardiomyopathy.
Each participant in the metoprolol group will be started on 25 mg of metoprolol tartrate twice a day prior to initiation of the anthracycline or trastuzumab. After one week, this dose will be increased to 50 mg twice daily, if tolerated. Prior to increasing the dose, the patients will be seen in the cardiology research clinic by the study doctor and evaluated for side effects. After another week the dose will again be increased to 100 mg twice daily. The dose can be decreased at any time if side effects occur such as bradycardia with HR less than 50 or hypotension with SBP less than 90. The beta blocker will be held for two days prior to the post-treatment MUGA so as not to acutely affect heart rate, as a decrease in heart rate would be expected to increase EF14. Abrupt cessation of metoprolol tartrate will not lead to withdrawal of beta-blockade. This study will end with the post-treatment MUGA. The primary end point of this study will be the change in EF before and after anthracycline or trastuzumab treatment. A pill diary will be maintained to document compliance of study medication.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metoprolol | Active comparator | Drug: MetoprololReceiving metoprolol |
| Control | No intervention | –Not receiving metoprolol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients must have confirmed malignancy for which standard regimens of anthracyclines or trastuzumab are being offered as treatment at the University of Maryland Greenebaum Cancer Center. Patients must either receive 4 cycles of anthracycline for a total dose of 240 mg/m2 or six cycles of TAC for a total dose of 300 mg/m2 or trastuzumab.
- Age > 18 years
- Ability to understand and willingness to sign a written informed consent document.
- Women of childbearing potential may participate in this study only if they have a negative pregnancy test and agree not to become pregnant during the study. Woman of childbearing potential must use an effective method of birth control such as hormonal contraceptives (oral and implant) condoms, diaphragms, spermicidal foam or jelly, surgical (hysterectomy or tubal ligation) or intrauterine device.
Key exclusion criteria (6 listed)
- Patients who have established dilated or restrictive cardiomyopathy with EF < 40 %.
- Patients with severe mitral or aortic valve disease (valve area <1cm squared).
- Patients who have any contraindication to metoprolol, in particular bradycardia with HR < 50, or severe reactive pulmonary disease such as asthma. Patients who take mibefradil or psychiatric drugs (such as phenothiazines including chlorpromazine and thioridazine) will also be excluded from the study as they have serious interactions with beta-blockers
- Patients who have untreated thyroid function disorder.
- Pregnant and nursing women are excluded from this study because of potential risk for adverse events to the fetus.
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 |
|---|---|---|
| MetoprololMetroprolol tartrate titrated up | Drug | Metoprolol |
Primary outcome
Ejection Fraction by MUGA
Time frame: Pre and post anthracycline treatment
Because of the inability to enroll an adequate number of patients, (only 15 out of a planned 50) no data analysis was collected or performed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Stephen S Gottlieb, MD principal investigator
University of Maryland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metoprolol in people with Cardiomyopathy, run by University of Maryland, Baltimore at 1 site 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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 25 Feb 2022. 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 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 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?
Yes. Results are posted in the registry (first posted 22 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Ejection Fraction by MUGA (time frame: Pre and post anthracycline treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2022.