Effect of Pharmacological Heart Rate Reduction on Visco-elastic Properties of the Arterial Wall (BRADYVASC) (BRADYVASC)

April 13, 2026 updated by: University Hospital, Rouen

The conduit arteries exhibit a viscoelastic behavior. Visco-elasticity is partially regulated by endothelium and contributes to the optimization of the heart-vessel coupling. Aging or high resting heart rate (HR) could alter visco-elastic properties leading to increase stiffness of the conduit arteries, an independent cardiovascular risk factor, and degradation of heart-vessel coupling. Lowering HR with ivabradine could reduce these effects.

The objective of this study is to assess the effect of HR reduction by repeated administration of ivabradine on visco-elastic properties, vascular geometry and function of common carotid artery, and on cardiovascular hemodynamic in healthy subject. The influence of aging on ivabradine effects are studied too.

30 healthy volunteers aged between 25 and 65 years old, with a HR ≥ 70 bpm, will receive ivabradine or placebo during 8 days in a single center, randomized, cross-group, double blinded, placebo-controlled study. Each period of treatment will be separate by 12 to 16 days of wash-out. Each subject will participate in an exploration visit, including evaluation of visco-elastic properties, vascular geometry and function of common carotid artery, and cardiovascular hemodynamic, before and after ivabradine or placebo taking.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rouen, France, 76000
        • Department of Pharmacology, Rouen university Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy volunteers
  • Caucasian
  • Resting heart rate ≥70 bpm (mean of 3 measures after 15 minutes of rest)
  • No significant EKG abnormality
  • No significant biological abnormalities at inclusion
  • Healthy volunteers able to read and understand information letter and to give written informed consent
  • Healthy volunteers with medical insurance
  • Contraception for two months for women of childbearing age (Estrogen contraceptive or intrauterine device or tubal ligation) (NB : women with amenorrhea for more than 2 years will be considered postmenopausal)

Exclusion Criteria:

  • Subjects who don't understand french language
  • Person deprived of liberty by an administrative or judicial decision or protected adult subject (under guardianship)
  • Pregnant women, nursing mother or women without contraception
  • Healthy volunteers who participate to an other trial / participated to an other trial without drugs during the last month or a trial with drugs during the last 3 months
  • Hypersensitivity to the active substance or to any of the excipients
  • Congenital galactosemia, lactase deficiency, or glucose-galactose malabsorption
  • Body mass index (BMI) < 18 kg/m² or > 30 kg/m²
  • Severe hypotension (< 90/50 mmHg) (3 measures after 15 minutes of rest)
  • Essential or secondary Hypertension (SBP ≥140 mmHg and/or DBP ≥90 mmHg) (3 measures after 15 minutes of rest)
  • Active smoking at the day of inclusion (>5 cigarettes/day)
  • Severe hypercholesterolemia (Total cholesterol >2,5 g/L)
  • Practice sports intensively (≥ 1 hour/day)
  • Renal insufficiency (creatinine clearance ≤ 60 ml/min/1,73 m² Cockroft and Gault formula)
  • Known liver failure
  • Known heart failure or suspected heart failure (congestive episode)
  • Atrial fibrillation
  • High-grade conduction block (Sick sinus syndrome, sino-atrial block or grade 2 or 3 atrio-ventricular block)
  • Abnormal corrected QT with Bazett formula (cQT > 450 ms (men) or > 470 ms (women)).
  • Pacemaker
  • All cardiac or extra cardiac diseases, active or with sequelae, which, in the opinion of the investigator, is accompanied by a risk of cardiac or vascular consequences
  • Retinal disease
  • Taking any medication is prohibited during the study except oral contraceptive, acetaminophene or decision of the investigator. In addition, the administration of drugs listed in schedule 2 during the previous 4 weeks prohibits inclusion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: ivabradine-placebo
Volunteers will receive, at meal, ivabradine 5 mg morning and evening for the first period of treatment during 8 days (1 capsule on day 1 and then 1 capsule 2 times a day from day 2 to day 7 and 1 capsule on day 8). A wash out period (12 to 16 days) will follow this first period of treatment. of wash-out . Then, volunteers will receive, at meal, lactose capsule (placebo) morning and evening for the first period of treatment during 8 days (1 capsule on day 1 and then 1 capsule 2 times a day from day 2 to day 7 and 1 capsule on day 8).
Drug: ivabradine
It is a cross over study with two arms : either ivabradine-placebo or placebo-ivabradine. The capsules containing the placebo or ivabradine are completely identical.
Other Names:
  • Procoralan
Drug: lactose capsule (placebo)
It is a cross over study with two arms : either ivabradine-placebo or placebo-ivabradine. The capsules containing the placebo or ivabradine are completely identical.
Other: placebo-ivabradine
Volunteers will receive, at meal, lactose capsule (placebo) morning and evening for the first period of treatment during 8 days (1 capsule on day 1 and then 1 capsule 2 times a day from day 2 to day 7 and 1 capsule on day 8). A wash out period (12 to 16 days) will follow this first period of treatment. of wash-out . Then, volunteers will receive, at meal, ivabradine 5 mg morning and evening for the first period of treatment during 8 days (1 capsule on day 1 and then 1 capsule 2 times a day from day 2 to day 7 and 1 capsule on day 8).
Drug: ivabradine
It is a cross over study with two arms : either ivabradine-placebo or placebo-ivabradine. The capsules containing the placebo or ivabradine are completely identical.
Other Names:
  • Procoralan
Drug: lactose capsule (placebo)
It is a cross over study with two arms : either ivabradine-placebo or placebo-ivabradine. The capsules containing the placebo or ivabradine are completely identical.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in viscosity of the common carotid artery
Time Frame: 8 days after first administration of ivabradine or placebo
8 days after first administration of ivabradine or placebo

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in diameter of the common carotid artery
Time Frame: 8 days after first administration of ivabradine or placebo
8 days after first administration of ivabradine or placebo
Change from baseline in intima-media thickness of the common carotid artery
Time Frame: 8 days after first administration of ivabradine or placebo
8 days after first administration of ivabradine or placebo
Change from baseline in carotid distensibility
Time Frame: 8 days after first administration of ivabradine or placebo
8 days after first administration of ivabradine or placebo
Change from baseline in carotid-femoral pulse wave velocity
Time Frame: 8 days after first administration of ivabradine or placebo
8 days after first administration of ivabradine or placebo
Change from baseline in plasma levels of biomarkers of endothelial function
Time Frame: 8 days after first administration of ivabradine or placebo
8 days after first administration of ivabradine or placebo
Change from baseline in peripheral and central pressures
Time Frame: 8 days after first administration of ivabradine or placebo
8 days after first administration of ivabradine or placebo
Change from baseline in Buckberg index
Time Frame: 8 days after first administration of ivabradine or placebo
8 days after first administration of ivabradine or placebo
Change from baseline in cardiac output
Time Frame: 8 days after first administration of ivabradine or placebo
8 days after first administration of ivabradine or placebo

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

  • Principal Investigator: Frederic Roca, MD, University Hospital, Rouen
  • Study Chair: Robinson Joannides, MD,PhD, University Hospital, Rouen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2015

Primary Completion (Actual)

July 15, 2019

Study Completion (Actual)

July 15, 2019

Study Registration Dates

First Submitted

October 21, 2015

First Submitted That Met QC Criteria

October 21, 2015

First Posted (Estimated)

October 22, 2015

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015/077/HP
  • 2015-002060-17 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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