NCT00251602

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Mar 2003

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 10, 2005

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

August 6, 2012

Status Verified

August 1, 2012

Enrollment Period

9.4 years

First QC Date

November 8, 2005

Last Update Submit

August 3, 2012

Conditions

Healthy

Keywords

heart rate variabilitygene response

Outcome Measures

Primary Outcomes (1)

  • Changes in heart rate and blood pressure

    every 2 minutes during drug infusions and every 10 minutes during the remainder of the study time

Study Arms (6)

1

EXPERIMENTAL

II ACE genotype

Drug: AtropineDrug: Propranolol

2

EXPERIMENTAL

ID ACE genotype

Drug: AtropineDrug: Propranolol

3

EXPERIMENTAL

DD ACE genotype

Drug: AtropineDrug: Propranolol

4

PLACEBO COMPARATOR

II ACE genotype

Drug: PropranololDrug: Normal Saline

5

PLACEBO COMPARATOR

ID ACE genotype

Drug: PropranololDrug: Normal Saline

6

PLACEBO COMPARATOR

DD ACE genotype

Drug: PropranololDrug: Normal Saline

Interventions

AtropineDRUG

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

123
PropranololDRUG

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

123456
Normal SalineDRUG

One-time 0.25 ml/min infusion over 30 minutes

Also known as: NS
456

Eligibility Criteria

Age21 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute on Aging, Harbor Hospital

Baltimore, Maryland, 21225, United States

Location

Related Publications (3)

  • 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.

    PMID: 6166045BACKGROUND

  • 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.

    PMID: 7733345BACKGROUND

  • 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.

    PMID: 2874900BACKGROUND

MeSH Terms

Interventions

AtropinePropranololSaline Solution

Intervention Hierarchy (Ancestors)

Atropine DerivativesTropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsBelladonna AlkaloidsSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-RingPhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsPropanolsAminesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Shari M. Ling, MD

    National Institute on Aging, Clinical Research Branch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2005

First Posted

November 10, 2005

Study Start

March 1, 2003

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

August 6, 2012

Record last verified: 2012-08

Locations

US(1)