Effects of Heart Rate Reduction on Central Arterial Pressure in Healthy Individuals

Central Arterial Pressure Clinical Trial

Official title:

The Influence of Heart Rate Reduction Upon Central Arterial Pressure in Younger and Older Healthy Individuals

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00825123
• Other study ID #: 141/07 bayside health
• Status: Terminated
• Phase: Phase 4
• Start date: October 2008
• Est. completion date: November 8, 2011

Study information

• Verified date: November 2009
• Source: Bayside Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: November 8, 2011
• Est. primary completion date: November 8, 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

Healthy volunteers:

• aged 18 - 25 years OR

• aged >60 years

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Central Arterial Pressure

Intervention

Drug:
• Ivabradine
Ivabradine 10 mg once
• Metoprolol
Metoprolol 50 mg once
• Placebo
Lactose powder

Locations

Country	Name	City	State
Australia	The Alfred Hospital	Melbourne	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
Bayside Health	Baker IDI Heart and Diabetes Institute

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	central arterial pressure		baseline and 4 hours post treatment