Ability of Metoprolol to Alter the Exercise Induced Elevation of Catecholamines

NCT ID: NCT00885651

Last Updated: 2009-04-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2009-12-31

Brief 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.

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Metoprolol for 10 days followed by placebo for 7 days.

Group Type: EXPERIMENTAL

Metoprolole (Selo-Zok ®)

Intervention Type: DRUG

Tablets, 200 mg, once a day, 10 days

Placebo

Intervention Type: DRUG

2

Placebo for 7 days followed by Metoprolol for 10 days

Group Type: PLACEBO_COMPARATOR

Metoprolole (Selo-Zok ®)

Intervention Type: DRUG

Tablets, 200 mg, once a day, 10 days

Placebo

Intervention Type: DRUG

Interventions

Metoprolole (Selo-Zok ®)

Tablets, 200 mg, once a day, 10 days

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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
• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Danish Heart Foundation

OTHER

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Morten Petersen, Department of Clinical Pharmacology, Rigshospitalet, Denmark

Principal Investigators

Henrik HP Enghusen Poulsen, MD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Universityhospital of Copenhagen

References

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.

Reference Type: DERIVED

PMID: 22703382 (View on PubMed)

Other Identifiers

EudraCTnr. 2008-001908-23

Identifier Type: -

Identifier Source: secondary_id

13-5-23-9-3-8-15

Identifier Type: -

Identifier Source: org_study_id