Heart FailurePhase 4MEXICHONCT00885651
Ability of Metoprolol to Alter the Exercise Induced Elevation of Catecholamines
A Phase 4 study testing Metoprolole (Selo-Zok ®) in people with Heart Failure, run by Copenhagen University Hospital, Rigshospitalet.
Trial summary
Heart failure is a frequent disease in Denmark, and it is associated with very high mortality. Around 60,000 people in Denmark have heart failure, and there is about 11,000 hospitalizations every year due to this disease. From the time of diagnosis, patients survive an average of 4-5 years. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Metoprolole (Selo-Zok ®)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to Dec 2009
- 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 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Kaukaser
- Healthy men
- 18 years < age < 30 years
- Non-smoker
- 18 < BMI < 25
- No chronic diseases
- Motor-disability that disables completement of cardio-pulmonary exercise-test.
Who cannot join
- Alcohol abuse or any other abuse
- Intake of any narcotic drugs (example: cannabinoids, narcotics, stimulants of central nervous system, hypnotics, hallucinogenes)
- Any of following medication:
- astmamedication
- heartmedication
- antihistamines
Show all 17Show fewer
- antipsycotics
- NSAIDs
- rifampicine
- chinidine
- glucocorticoids
- Abnormal ECG, particularly 2. or 3. degree AV-block, sinusbradycardia, sick sinusnode-syndrome, sign of heart failure or ischemia.
- Allergy or intolerance of metoprolole
- Lactoseallergy
- 110 mmHg < Systolic blood pressure < 140 mmHg
- 60 mmHg < Diastolic blood pressure < 90 mmHg
- Bloodsucker > 11,1 mmol/L, or fasting, venous bloodsucker >= 7,0 (measured if: 7,8 < BS < 11,1)
About this study
Official title: A Randomised, Double Blinded, Crossover Study of the Influence of Metoprolol on Exercise Induced Elevation of Catecholamines in Healthy Subjects.
Heart failure is a frequent disease in Denmark, and it is associated with very high mortality. Around 60,000 people in Denmark have heart failure, and there is about 11,000 hospitalizations every year due to this disease. From the time of diagnosis, patients survive an average of 4-5 years.
A critical illness mechanism in heart failure is that these patients have high blood levels of catecholamines; epinephrine and norepinephrine, which is stress hormones from the sympathetic nervous system. Standard treatment of heart failure is with the two medical preparations betablockers and ACE-inhibitors.
Read more
It is not known what effect betablocker-treatment have on blood concentration of epinephrine and norepinephrine.
It is the purpose of this study, to investigate the effect of Selo-Zok ® (metoprolol) on the blood concentration of epinephrine and norepinephrine. This is done by creating a stress condition for the body, in this case with the bicycle test, while doing blood samples to determine the concentration of catecholamines. This will be done by 1-week treatment of tablet Selo-Zok ® followed by 1-week treatment of placebo (a substance with no medical effect). Blood samples will be taken to determine small changes in inheritance material (DNA) in the form of point mutations also called single nucleotide polymorphisms, since these changes can affect how we respond to metoprolol treatment.
- Conditions
- Heart Failure
- Being tested
- Metoprolole (Selo-Zok ®), Placebo
- Keywords
- SNP, catecholamines, metoprolole, healthy subjects, physiological stress
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metoprolole (Selo-Zok ®)Drug
Tablets, 200 mg, once a day, 10 days
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Metoprolol for 10 days followed by placebo for 7 days. Receives: Drug: Metoprolole (Selo-Zok ®); Drug: Placebo |
| 2 | Placebo comparator | Placebo for 7 days followed by Metoprolol for 10 days Receives: Drug: Metoprolole (Selo-Zok ®); Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in stress-triggered response of catecholamines.
Measured: 2 weeks and 3 days
Secondary outcomes (2)
Change in stress-triggered blood pressure response.
Measured: 2 weeks and 3 days
Change in stress-triggered pulse response.
Measured: 2 weeks and 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2009 (estimated)
- Study startSep 2008
- Primary completionAug 2009 (estimated)
- Study completionDec 2009 (estimated)
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 FailureStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Heart Foundation
- Investigators
- Henrik HP Enghusen Poulsen, MD, Principal investigator, Rigshospitalet, Universityhospital of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00885651
- Sponsor's protocol ID
- 13-5-23-9-3-8-15
- Other IDs
- EudraCTnr. 2008-001908-23
- Acronym
- MEXICHO
- Status last verified
- Apr 2009
- First submitted
- 20 Apr 2009
- Last updated
- 22 Apr 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Petersen M, Andersen JT, Jimenez-Solem E, Broedbaek K, Hjelvang BR, Henriksen T, Frandsen E, Forman JL, Torp-Pedersen C, Kober L, Poulsen HE. Effect of the Arg389Gly beta(1)-adrenoceptor polymorphism on plasma renin activity and heart rate, and the genotype-dependent response to metoprolol treatment. Clin Exp Pharmacol Physiol. 2012 Sep;39(9):779-85. doi: 10.1111/j.1440-1681.2012.05736.x.
PubMed 22703382
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double Blinded, Crossover Study of the Influence of Metoprolol on Exercise Induced Elevation of Catecholamines in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT00885651
- Acronym / sponsor ID
- MEXICHO / 13-5-23-9-3-8-15
- Conditions
- Heart Failure
- Keywords
- SNP, catecholamines, metoprolole, healthy subjects, physiological stress
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Danish Heart Foundation
- Study start
- Sep 2008
- Primary completion
- Aug 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 22 Apr 2009 (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.
Heart failure is a frequent disease in Denmark, and it is associated with very high mortality. Around 60,000 people in Denmark have heart failure, and there is about 11,000 hospitalizations every year due to this disease. From the time of diagnosis, patients survive an average of 4-5 years.
A critical illness mechanism in heart failure is that these patients have high blood levels of catecholamines; epinephrine and norepinephrine, which is stress hormones from the sympathetic nervous system. Standard treatment of heart failure is with the two medical preparations betablockers and ACE-inhibitors.
It is not known what effect betablocker-treatment have on blood concentration of epinephrine and norepinephrine.
It is the purpose of this study, to investigate the effect of Selo-Zok ® (metoprolol) on the blood concentration of epinephrine and norepinephrine. This is done by creating a stress condition for the body, in this case with the bicycle test, while doing blood samples to determine the concentration of catecholamines. This will be done by 1-week treatment of tablet Selo-Zok ® followed by 1-week treatment of placebo (a substance with no medical effect). Blood samples will be taken to determine small changes in inheritance material (DNA) in the form of point mutations also called single nucleotide polymorphisms, since these changes can affect how we respond to metoprolol treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Metoprolole (Selo-Zok ®), Drug: PlaceboMetoprolol for 10 days followed by placebo for 7 days. |
| 2 | Placebo comparator | Drug: Metoprolole (Selo-Zok ®), Drug: PlaceboPlacebo for 7 days followed by Metoprolol for 10 days |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Kaukaser
- Healthy men
- 18 years < age < 30 years
- Non-smoker
- 18 < BMI < 25
Key exclusion criteria (17 listed)
- Alcohol abuse or any other abuse
- Intake of any narcotic drugs (example: cannabinoids, narcotics, stimulants of central nervous system, hypnotics, hallucinogenes)
- Any of following medication:
- Abnormal ECG, particularly 2. or 3. degree AV-block, sinusbradycardia, sick sinusnode-syndrome, sign of heart failure or ischemia.
- Allergy or intolerance of metoprolole
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 |
|---|---|---|
| Metoprolole (Selo-Zok ®)Tablets, 200 mg, once a day, 10 days | Drug | 1, 2 |
| Placebo | Drug | 1, 2 |
Primary outcome
Changes in stress-triggered response of catecholamines.
Time frame: 2 weeks and 3 days
2 secondary outcomes
Change in stress-triggered blood pressure response.
Time frame: 2 weeks and 3 days
Change in stress-triggered pulse response.
Time frame: 2 weeks and 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2009.
- Derived from this study: PubMed 22703382Petersen M, Andersen JT, Jimenez-Solem E, Broedbaek K, Hjelvang BR, Henriksen T, Frandsen E, Forman JL, Torp-Pedersen C, Kober L, Poulsen HE. Effect of the Arg389Gly beta(1)-adrenoceptor polymorphism on plasma renin activity and heart rate, and the genotype-dependent response to metoprolol treatment. Clin Exp Pharmacol Physiol. 2012 Sep;39(9):779-85. doi: 10.1111/j.1440-1681.2012.05736.x.
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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.
Henrik HP Enghusen Poulsen, MD principal investigator
Rigshospitalet, Universityhospital of Copenhagen
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metoprolole (Selo-Zok ®) in people with Heart Failure, run by Copenhagen University Hospital, Rigshospitalet.
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 7 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 22 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Changes in stress-triggered response of catecholamines. (time frame: 2 weeks and 3 days). 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 NCT00885651, 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 Apr 2009.