Ability of Metoprolol to Alter the Exercise Induced Elevation of Catecholamines

NCT00885651 | Unknown Phase 4 DMC

• 2 other identifiers: 13-5-23-9-3-8-15EudraCTnr. 2008-001908-23
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Keywords

SNP; catecholamines; metoprolole; healthy subjects; physiological stress

Outcome Measures

Primary Outcomes (1)

• Changes in stress-triggered response of catecholamines.

  2 weeks and 3 days

Secondary Outcomes (2)

• Change in stress-triggered blood pressure response.

  2 weeks and 3 days

• Change in stress-triggered pulse response.

  2 weeks and 3 days

Study Arms (2)

1

EXPERIMENTAL

Metoprolol for 10 days followed by placebo for 7 days.

Drug: Metoprolole (Selo-Zok ®); Drug: Placebo

2

PLACEBO COMPARATOR

Placebo for 7 days followed by Metoprolol for 10 days

Drug: Metoprolole (Selo-Zok ®); Drug: Placebo

Interventions

Metoprolole (Selo-Zok ®) DRUG

Tablets, 200 mg, once a day, 10 days

1; 2

Placebo DRUG

1; 2

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Kaukaser
• Healthy men
• years \< age \< 30 years
• Non-smoker
• \< BMI \< 25
• No chronic diseases
• Motor-disability that disables completement of cardio-pulmonary exercise-test.

You may not qualify if:

• 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
• mmHg \< Systolic blood pressure \< 140 mmHg

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Danish Heart Foundation: collaborator

Related Publications (1)

• 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.

  PMID: 22703382 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Henrik HP Enghusen Poulsen, MD

  Rigshospitalet, Universityhospital of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 20, 2009
• First Posted: April 22, 2009
• Study Start: September 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: December 1, 2009
• Last Updated: April 22, 2009

Record last verified: 2009-04