Heart FailurePhase 4NCT00384566
A Comparison of the Effect of Carvedilol and Metoprolol on Airways Tone in Patients With Heart Failure
A Phase 4 study testing Carvedilol and Metoprolol in people with Heart Failure and Chronic Obstructive Airway Disease, run by The Alfred at 1 site in Australia.
Trial summary
This study looks at the effect of two drugs (carvedilol and metoprolol) which are used for patients with CHF (chronic heart failure). These agents are beta-blockers and, although effective in heart failure, may cause increases in airways tone and thus limit air getting into the lower parts of the lungs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Chronic Obstructive Airway Disease
- What is being tested?
- Carvedilol and Metoprolol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteAustralia
- Study dates
- Jun 2005to Apr 2008
- 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
Who may be able to join
- males and females over 18 years of age
- Documented CHF (NYHA class II-IV symptoms)
- Airflow obstruction defined as patients with symptomatic obstructive respiratory disease as manifest by any of the following Symptoms of wheeze, primarily attributed to airflow obstruction Requirement for intermittent or regular bronchodilator therapy FEV1 less than 70% predicted pre-salbutamol
- Confirmed written informed consent.
- Clinically indicated to receive β-blockade.
- No evidence of heart block on ECG.
- Patients will be in one of the following categories:
- Currently on carvedilol Currently on Toprol-XL or Metoprolol tartrate Currently on bisoprolol Clinically indicated to receive β adrenoceptor blockade but not currently prescribed a β-blocker.
Who cannot join
- Women lactating, pregnant or of childbearing potential not using a reliable contraceptive method.
- Patients who had received an investigational new drug within the last 4 weeks.
- Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study.
- Laboratory parameters:
- Creatinine >0.30 mmol/l Liver function tests 3x ULN
- Recent (<12 months) myocarditis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The CAMERA Study: CArvedilol MEtoprolol Respiratory Assessment Investigator Trial
This study looks at the effect of two drugs (carvedilol and metoprolol) which are used for patients with CHF (chronic heart failure).
These agents are beta-blockers and, although effective in heart failure, may cause increases in airways tone and thus limit air getting into the lower parts of the lungs. Carvedilol is more active at blocking the receptor that opens up the airways and therefore theoretically may be more likely to reduce airways tone than metoprolol, although this has never been studied in patients with heart failure, and that is the purpose of the present study.
Read more
We are looking to enrol 45 patients with heart failure and mild obstruction to the flow of air in their lungs. Patients will be randomised to either carvedilol or metoprolol (standard doses). Following a minimum of 2 weeks of therapy of study medication the patient will undergo a study day involving an assessment of their lung function, an assessment of their heart failure, a "living with heart failure" questionnaire, blood tests and blood pressure and heart rate readings.
Patients will then be crossed over to the alternate medication. Following 2 weeks on the target dose the patient will undergo their second study day which will be the same as the first.
The results obtained from each study day will be compared.
- Conditions
- Heart Failure, Chronic Obstructive Airway Disease
- Being tested
- Carvedilol, Metoprolol
- Medical subject headings
- Heart Failure, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarvedilolDrug
anit hypertensive medication
MetoprololDrug
Anti hypertensive medication
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Carvedilol |
| 2 | Active comparator | Not described Receives: Drug: Metoprolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory function
Measured: Each study visit
NYHA class with the use of the 7 point scale (Packer).
Measured: Baseline, cross over, end of study
Minnesota "living with Heart Failure" questionnaire.
Measured: Baseline, cross over, end of study
U+E
Measured: Screening, cross over, end of study
BP and HR
Measured: every visit
plasma N-terminal pro-BNP
Measured: Screening, cross over, end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2006 (estimated)
- Study startJun 2005
- Primary completionApr 2008
- Study completionApr 2008
Why it stopped: In order to join forces with another study already running which aims to answer the same question.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Alfred
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Investigators
- Henry Krum, Professor, Principal investigator, Monash University / Alfred Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00384566
- Sponsor's protocol ID
- CP-03/04
- Status last verified
- Jun 2015
- First submitted
- 5 Oct 2006
- Last updated
- 24 Jun 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CAMERA Study: CArvedilol MEtoprolol Respiratory Assessment Investigator Trial
- ClinicalTrials.gov ID
- NCT00384566
- Acronym / sponsor ID
- CP-03/04
- Conditions
- Heart Failure, Chronic Obstructive Airway Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: In order to join forces with another study already running which aims to answer the same question.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The AlfredUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- Jun 2005
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 6 Oct 2006 (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.
This study looks at the effect of two drugs (carvedilol and metoprolol) which are used for patients with CHF (chronic heart failure).
These agents are beta-blockers and, although effective in heart failure, may cause increases in airways tone and thus limit air getting into the lower parts of the lungs. Carvedilol is more active at blocking the receptor that opens up the airways and therefore theoretically may be more likely to reduce airways tone than metoprolol, although this has never been studied in patients with heart failure, and that is the purpose of the present study.
We are looking to enrol 45 patients with heart failure and mild obstruction to the flow of air in their lungs. Patients will be randomised to either carvedilol or metoprolol (standard doses). Following a minimum of 2 weeks of therapy of study medication the patient will undergo a study day involving an assessment of their lung function, an assessment of their heart failure, a "living with heart failure" questionnaire, blood tests and blood pressure and heart rate readings.
Patients will then be crossed over to the alternate medication. Following 2 weeks on the target dose the patient will undergo their second study day which will be the same as the first.
The results obtained from each study day will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Carvedilol |
| 2 | Active comparator | Drug: Metoprolol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- males and females over 18 years of age
- Documented CHF (NYHA class II-IV symptoms)
- Airflow obstruction defined as patients with symptomatic obstructive respiratory disease as manifest by any of the following Symptoms of wheeze, primarily attributed to airflow obstruction Requirement for intermittent or regular bronchodilator therapy FEV1 less than 70% predicted pre-salbutamol
- Confirmed written informed consent.
- Clinically indicated to receive β-blockade.
Key exclusion criteria (6 listed)
- Women lactating, pregnant or of childbearing potential not using a reliable contraceptive method.
- Patients who had received an investigational new drug within the last 4 weeks.
- Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study.
- Laboratory parameters:
- Creatinine >0.30 mmol/l Liver function tests 3x ULN
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 |
|---|---|---|
| Carvedilolanit hypertensive medication | Drug | 1 |
| MetoprololAnti hypertensive medication | Drug | 2 |
Primary outcome
Respiratory function
Time frame: Each study visit
NYHA class with the use of the 7 point scale (Packer).
Time frame: Baseline, cross over, end of study
Minnesota "living with Heart Failure" questionnaire.
Time frame: Baseline, cross over, end of study
U+E
Time frame: Screening, cross over, end of study
BP and HR
Time frame: every visit
plasma N-terminal pro-BNP
Time frame: Screening, cross over, end of study
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2015.
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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.
Henry Krum, Professor principal investigator
Monash University / Alfred Hospital
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 Carvedilol and Metoprolol in people with Heart Failure and Chronic Obstructive Airway Disease, run by The Alfred at 1 site in Australia.
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 8 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: withdrawn, as of the sponsor's last update on 24 Jun 2015. 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 Australia. 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 was withdrawn before enrolling participants, so there are no results.
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?
Respiratory function (time frame: Each study visit). The study lists 6 primary outcomes in all. 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 24 Jun 2015.