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Analysis of Atropine and Propranolol Induced Changes

NCT ID: NCT00251602

Last Updated: 2012-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2012-08-31

Brief Summary

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The purpose of this study is to learn the effects of genetic make up on response to the drugs atropine and propranolol, to examine how changes in heart rate and blood pressure can be measured, and to test a new statistical analysis method.

Detailed Description

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Healthy volunteers will be recruited and screened for eligibility. Participants will be placed into three possible groups based on genetic information obtained during screening. Rolling admissions will continue until at least 10 participants have been recruited for each genetic group. Participants will be randomly assigned to receive either the control (propranolol and saline) or combined drug (propranolol and atropine) treatment in a non-blinded fashion. The participant will return over one week later to receive the alternate treatment. Continuous heart rate/blood pressure data will be recorded until the end of the study period. Respiratory rate will be maintained at a fixed rate. Participants will undergo an orthostasis task, receive the drug or control infusions, and blood samples will then be obtained to determine drug concentrations at specific time intervals. Several relatively new mathematical techniques will be applied to the data.

Conditions

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Healthy

Keywords

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heart rate variability gene response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

II ACE genotype

Group Type EXPERIMENTAL

Atropine

Intervention Type DRUG

One-time 10 mcg/kg infusion over 30 minutes, followed by a 10 mcg/kg bolus

Propranolol

Intervention Type DRUG

One-time 0.8mg/kg/hr infusion (maximum dose not to exceed 20mg) over 20 minutes, followed by either atropine or normal saline

2

ID ACE genotype

Group Type EXPERIMENTAL

Atropine

Intervention Type DRUG

One-time 10 mcg/kg infusion over 30 minutes, followed by a 10 mcg/kg bolus

Propranolol

Intervention Type DRUG

One-time 0.8mg/kg/hr infusion (maximum dose not to exceed 20mg) over 20 minutes, followed by either atropine or normal saline

3

DD ACE genotype

Group Type EXPERIMENTAL

Atropine

Intervention Type DRUG

One-time 10 mcg/kg infusion over 30 minutes, followed by a 10 mcg/kg bolus

Propranolol

Intervention Type DRUG

One-time 0.8mg/kg/hr infusion (maximum dose not to exceed 20mg) over 20 minutes, followed by either atropine or normal saline

4

II ACE genotype

Group Type PLACEBO_COMPARATOR

Propranolol

Intervention Type DRUG

One-time 0.8mg/kg/hr infusion (maximum dose not to exceed 20mg) over 20 minutes, followed by either atropine or normal saline

Normal Saline

Intervention Type DRUG

One-time 0.25 ml/min infusion over 30 minutes

5

ID ACE genotype

Group Type PLACEBO_COMPARATOR

Propranolol

Intervention Type DRUG

One-time 0.8mg/kg/hr infusion (maximum dose not to exceed 20mg) over 20 minutes, followed by either atropine or normal saline

Normal Saline

Intervention Type DRUG

One-time 0.25 ml/min infusion over 30 minutes

6

DD ACE genotype

Group Type PLACEBO_COMPARATOR

Propranolol

Intervention Type DRUG

One-time 0.8mg/kg/hr infusion (maximum dose not to exceed 20mg) over 20 minutes, followed by either atropine or normal saline

Normal Saline

Intervention Type DRUG

One-time 0.25 ml/min infusion over 30 minutes

Interventions

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Atropine

One-time 10 mcg/kg infusion over 30 minutes, followed by a 10 mcg/kg bolus

Intervention Type DRUG

Propranolol

One-time 0.8mg/kg/hr infusion (maximum dose not to exceed 20mg) over 20 minutes, followed by either atropine or normal saline

Intervention Type DRUG

Normal Saline

One-time 0.25 ml/min infusion over 30 minutes

Intervention Type DRUG

Other Intervention Names

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NS

Eligibility Criteria

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Inclusion Criteria

* Healthy male and female volunteers
* Ages 21-40
* Body Mass Index \>18.0 and \<27.0

Exclusion Criteria

* History of any chronic illnesses including cardiac diseases and bleeding problems
* Drug use of any kind
* Participation in any clinical trial within the last month
* Tobacco use and/or alcohol abuse
* Use of dietary supplements and unwillingness to refrain
Minimum Eligible Age

21 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shari M. Ling, MD

Role: PRINCIPAL_INVESTIGATOR

National Institute on Aging, Clinical Research Branch

Locations

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National Institute on Aging, Harbor Hospital

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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Akselrod S, Gordon D, Ubel FA, Shannon DC, Berger AC, Cohen RJ. Power spectrum analysis of heart rate fluctuation: a quantitative probe of beat-to-beat cardiovascular control. Science. 1981 Jul 10;213(4504):220-2. doi: 10.1126/science.6166045.

Reference Type BACKGROUND
PMID: 6166045 (View on PubMed)

Craft N, Schwartz JB. Effects of age on intrinsic heart rate, heart rate variability, and AV conduction in healthy humans. Am J Physiol. 1995 Apr;268(4 Pt 2):H1441-52. doi: 10.1152/ajpheart.1995.268.4.H1441.

Reference Type BACKGROUND
PMID: 7733345 (View on PubMed)

Pagani M, Lombardi F, Guzzetti S, Rimoldi O, Furlan R, Pizzinelli P, Sandrone G, Malfatto G, Dell'Orto S, Piccaluga E, et al. Power spectral analysis of heart rate and arterial pressure variabilities as a marker of sympatho-vagal interaction in man and conscious dog. Circ Res. 1986 Aug;59(2):178-93. doi: 10.1161/01.res.59.2.178.

Reference Type BACKGROUND
PMID: 2874900 (View on PubMed)

Other Identifiers

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AG0059

Identifier Type: -

Identifier Source: org_study_id