HealthyPhase 1NCT00251602
Analysis of Atropine and Propranolol Induced Changes
A Phase 1 study testing Atropine, Propranolol and Normal Saline in people with Healthy, run by National Institute on Aging (NIA) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Atropine, Propranolol and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2003to Aug 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female volunteers
- Ages 21-40
- Body Mass Index >18.0 and <27.0
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute on Aging, Harbor Hospital
Baltimore, Maryland, 21225
About this study
Official title: Wavelet Transform and Pharmacodynamic Analysis of Atropine and Propranolol Induced Changes in Human Heart Rate Variability
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.
Read the detailed description
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
- Healthy
- Being tested
- Atropine, Propranolol, Normal Saline
- Keywords
- heart rate variability, gene response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtropineDrug
One-time 10 mcg/kg infusion over 30 minutes, followed by a 10 mcg/kg bolus
PropranololDrug
One-time 0.8mg/kg/hr infusion (maximum dose not to exceed 20mg) over 20 minutes, followed by either atropine or normal saline
Normal SalineDrug
Also called NS
One-time 0.25 ml/min infusion over 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | II ACE genotype Receives: Drug: Atropine; Drug: Propranolol |
| 2 | Experimental | ID ACE genotype Receives: Drug: Atropine; Drug: Propranolol |
| 3 | Experimental | DD ACE genotype Receives: Drug: Atropine; Drug: Propranolol |
| 4 | Placebo comparator | II ACE genotype Receives: Drug: Propranolol; Drug: Normal Saline |
| 5 | Placebo comparator | ID ACE genotype Receives: Drug: Propranolol; Drug: Normal Saline |
| 6 | Placebo comparator | DD ACE genotype Receives: Drug: Propranolol; Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in heart rate and blood pressure
Measured: every 2 minutes during drug infusions and every 10 minutes during the remainder of the study time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2005 (estimated)
- Study startMar 2003
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Shari M. Ling, MD, Principal investigator, National Institute on Aging, Clinical Research Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00251602
- Sponsor's protocol ID
- AG0059
- Status last verified
- Aug 2012
- First submitted
- 8 Nov 2005
- Last updated
- 6 Aug 2012
- Results posted
- No
Publications
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.
PubMed 6166045Craft 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.
PubMed 7733345Pagani 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.
PubMed 2874900
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wavelet Transform and Pharmacodynamic Analysis of Atropine and Propranolol Induced Changes in Human Heart Rate Variability
- ClinicalTrials.gov ID
- NCT00251602
- Acronym / sponsor ID
- AG0059
- Conditions
- Healthy
- Keywords
- heart rate variability, gene response
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Study start
- Mar 2003
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 10 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Atropine, Drug: PropranololII ACE genotype |
| 2 | Experimental | Drug: Atropine, Drug: PropranololID ACE genotype |
| 3 | Experimental | Drug: Atropine, Drug: PropranololDD ACE genotype |
| 4 | Placebo comparator | Drug: Propranolol, Drug: Normal SalineII ACE genotype |
| 5 | Placebo comparator | Drug: Propranolol, Drug: Normal SalineID ACE genotype |
| 6 | Placebo comparator | Drug: Propranolol, Drug: Normal SalineDD ACE genotype |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male and female volunteers
- Ages 21-40
- Body Mass Index >18.0 and <27.0
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtropineOne-time 10 mcg/kg infusion over 30 minutes, followed by a 10 mcg/kg bolus | Drug | 1, 2, 3 |
| PropranololOne-time 0.8mg/kg/hr infusion (maximum dose not to exceed 20mg) over 20 minutes, followed by either atropine or normal saline | Drug | 1, 2, 3, 4, 5, 6 |
| Normal SalineAlso: NSOne-time 0.25 ml/min infusion over 30 minutes | Drug | 4, 5, 6 |
Primary outcome
Changes in heart rate and blood pressure
Time frame: every 2 minutes during drug infusions and every 10 minutes during the remainder of the study time
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2012.
- Background: PubMed 6166045Akselrod 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.
- Background: PubMed 7733345Craft 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.
- Background: PubMed 2874900Pagani 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shari M. Ling, MD principal investigator
National Institute on Aging, Clinical Research Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Atropine, Propranolol and Normal Saline in people with Healthy, run by National Institute on Aging (NIA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in heart rate and blood pressure (time frame: every 2 minutes during drug infusions and every 10 minutes during the remainder of the study time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00251602, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2012.