Ability of Metoprolol to Alter the Exercise Induced Eleva... | NCT00885651

Studies
Ability of Metoprolol to Alter the Exercise Induced Elevation of Catecholamines

NCT00885651

Sponsor

Rigshospitalet, Denmark

Status

Unknown status

Last Update Posted

Apr 22, 2009Estimated

Enrollment

30Estimated

Phase

Phase 4

Conditions

Heart Failure

Interventions

Metoprolole (Selo-Zok ®)
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EudraCTnr. 2008-001908-23

Status Module

Record Verification Date

Apr 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Aug 2009Estimated

Completion Date

Dec 2009Estimated

First Submitted Date

Apr 20, 2009

First Submission Date that Met QC Criteria

Apr 21, 2009

First Posted Date

Apr 22, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2009

Last Update Posted Date

Apr 22, 2009Estimated

Name	Class
Danish Heart Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Metoprolole (Selo-Zok ®)	Drug	Tablets, 200 mg, once a day, 10 days	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in stress-triggered response of catecholamines.		2 weeks and 3 days

Secondary Outcomes

Measure	Description	Time Frame
Change in stress-triggered blood pressure response.		2 weeks and 3 days
Change in stress-triggered pulse response.		2 weeks and 3 days

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Henrik HP Enghusen Poulsen, MD	Rigshospitalet, Universityhospital of Copenhagen	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22703382	Derived	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.

Type	Date	Date Unknown
Release	Aug 12, 2011
Reset	Sep 16, 2011
Release	Oct 19, 2011
Reset	Nov 23, 2011
Release	May 1, 2014
Reset	May 29, 2014

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Aug 12, 2011			Sep 16, 2011
Oct 19, 2011

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases