Central Arterial PressurePhase 4NCT00825123
Effects of Heart Rate Reduction on Central Arterial Pressure in Healthy Individuals
A Phase 4 study testing Ivabradine and Metoprolol in people with Central Arterial Pressure, run by Bayside Health at 1 site in Australia.
Trial summary
The purpose of this project is to determine the effects of slowing heart rate upon both central and peripheral blood pressures using Ivabradine. The effects of Ivabradine will be compared to Metoprolol and placebo. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Central Arterial Pressure
- What is being tested?
- Ivabradine and Metoprolol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteAustralia
- Study dates
- Oct 2008to 8 Nov 2011
- Phase
- Phase 4
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers:
- aged 18 - 25 years OR
- aged >60 years
Who cannot join
- Chronic disease
- Unable to give informed consent
- Treated or untreated systemic arterial hypertension (SBP >160mmHg and/or DBP > 90mmHg)
- Resting bradycardia (heart rate < 60 beats/minute)
- Pregnancy or active lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Heart Rate Reduction Upon Central Arterial Pressure in Younger and Older Healthy Individuals
The purpose of this project is to determine the effects of slowing heart rate upon both central and peripheral blood pressures using Ivabradine. The effects of Ivabradine will be compared to Metoprolol and placebo.
Participants will attend the hospital for 3 visits where they will be randomised to receive either Ivabradine, Metoprolol and placebo on each visit. Non-invasive measures of blood pressure will be recorded before and after consuming the study drug.
Read the detailed description
Participants will undergo three days of laboratory testing, each visit separated by at least seven days.
In order to assess each potential participant's suitability for the study based upon the relevant inclusion and exclusion criteria, the first visit will involve a medical consultation (history and physical examination), venepuncture (for full blood examination, lipid profile and biochemistry) and a 12-lead surface electrocardiogram. Baseline measurements of central and peripheral arterial and pulse wave velocity will be made at baseline, and 4 hours following the administration of either placebo, 50mg of metoprolol or a 10mg oral dose of ivabradine. The placebo will contain lactose powder.
Subjects will be randomized according to a 3-by-3 Latin square design. Central pulse pressure will be assessed using carotid artery tonometry using a non-invasive Millar Mikro-tip pressure transducer. The transducer is used to applanate the carotid artery and calibrated using brachial mean and diastolic blood pressure (automated oscillometric sphygmomanometer).
Pressure waveforms will also be recorded at the radial, brachial and femoral arteries to permit study of wave reflection at these sites.
Measurements will be taken be taken before and 4 hours following the oral administration of metoprolol/ivabradine/placebo.
Bias will be minimized by blinding both the participants and research staff responsible for data collection to the administered drug.
Any potential patient-specific confounding factors will have minimal impact, as the same participants will be studied after the administration of the three agents.
- Conditions
- Central Arterial Pressure
- Being tested
- Ivabradine, Metoprolol, Placebo
- Keywords
- healthy individuals
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvabradineDrug
Also called Coralan
Ivabradine 10 mg once
MetoprololDrug
Metoprolol 50 mg once
PlaceboDrug
Lactose powder
| Study group | Role | What they receive |
|---|---|---|
| Ivabradine | Experimental | Not described Receives: Drug: Ivabradine |
| Metoprolol | Active comparator | Not described Receives: Drug: Metoprolol |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
central arterial pressure
Measured: baseline and 4 hours post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2009 (estimated)
- Study startOct 2008
- Primary completion8 Nov 2011
- Study completion8 Nov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Arterial PressureStudies 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayside Health
- Sponsor type
- Other government
- Collaborators
- Baker Heart and Diabetes Institute
- Responsible party
- Sponsor
- Investigators
- Bronwyn A Kingwell, PhD, Principal investigator, Baker IDI Hearte & Diabetes Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00825123
- Sponsor's protocol ID
- 141/07 bayside health
- Status last verified
- Nov 2009
- First submitted
- 15 Jan 2009
- Last updated
- 17 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Heart Rate Reduction Upon Central Arterial Pressure in Younger and Older Healthy Individuals
- ClinicalTrials.gov ID
- NCT00825123
- Acronym / sponsor ID
- 141/07 bayside health
- Conditions
- Central Arterial Pressure
- Keywords
- healthy individuals
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Bayside HealthOther government
- Collaborators
- Baker Heart and Diabetes Institute
- Study start
- Oct 2008
- Primary completion
- 8 Nov 2011 (actual)
- Study completion
- 8 Nov 2011 (actual)
- First posted
- 19 Jan 2009 (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 project is to determine the effects of slowing heart rate upon both central and peripheral blood pressures using Ivabradine. The effects of Ivabradine will be compared to Metoprolol and placebo.
Participants will attend the hospital for 3 visits where they will be randomised to receive either Ivabradine, Metoprolol and placebo on each visit. Non-invasive measures of blood pressure will be recorded before and after consuming the study drug.
Detailed description
Participants will undergo three days of laboratory testing, each visit separated by at least seven days.
In order to assess each potential participant's suitability for the study based upon the relevant inclusion and exclusion criteria, the first visit will involve a medical consultation (history and physical examination), venepuncture (for full blood examination, lipid profile and biochemistry) and a 12-lead surface electrocardiogram. Baseline measurements of central and peripheral arterial and pulse wave velocity will be made at baseline, and 4 hours following the administration of either placebo, 50mg of metoprolol or a 10mg oral dose of ivabradine. The placebo will contain lactose powder.
Subjects will be randomized according to a 3-by-3 Latin square design. Central pulse pressure will be assessed using carotid artery tonometry using a non-invasive Millar Mikro-tip pressure transducer. The transducer is used to applanate the carotid artery and calibrated using brachial mean and diastolic blood pressure (automated oscillometric sphygmomanometer).
Pressure waveforms will also be recorded at the radial, brachial and femoral arteries to permit study of wave reflection at these sites.
Measurements will be taken be taken before and 4 hours following the oral administration of metoprolol/ivabradine/placebo.
Bias will be minimized by blinding both the participants and research staff responsible for data collection to the administered drug.
Any potential patient-specific confounding factors will have minimal impact, as the same participants will be studied after the administration of the three agents.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ivabradine | Experimental | Drug: Ivabradine |
| Metoprolol | Active comparator | Drug: Metoprolol |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged 18 - 25 years OR
- aged >60 years
Key exclusion criteria (5 listed)
- Chronic disease
- Unable to give informed consent
- Treated or untreated systemic arterial hypertension (SBP >160mmHg and/or DBP > 90mmHg)
- Resting bradycardia (heart rate < 60 beats/minute)
- Pregnancy or active lactation
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 |
|---|---|---|
| IvabradineAlso: CoralanIvabradine 10 mg once | Drug | Ivabradine |
| MetoprololMetoprolol 50 mg once | Drug | Metoprolol |
| PlaceboLactose powder | Drug | Placebo |
Primary outcome
central arterial pressure
Time frame: baseline and 4 hours post treatment
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2020.
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.
Bronwyn A Kingwell, PhD principal investigator
Baker IDI Hearte & Diabetes Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ivabradine and Metoprolol in people with Central Arterial Pressure, run by Bayside Health at 1 site in Australia.
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: stopped early, as of the sponsor's last update on 17 Aug 2020. 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 Australia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early. Results are not available in the source record.
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?
central arterial pressure (time frame: baseline and 4 hours post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2020; AzTrials last refreshed its copy on 8 Nov 2026.