HealthyPhase 3BRADYVASCNCT02584439
Effect of Pharmacological Heart Rate Reduction on Visco-elastic Properties of the Arterial Wall (BRADYVASC)
A Phase 3 study testing ivabradine in people with Healthy and Vascular Stiffness, run by University Hospital, Rouen at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Vascular Stiffness, Aging
- What is being tested?
- ivabradine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 3 Dec 2015to 15 Jul 2019
- Phase
- Phase 3
- 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 22Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Department of Pharmacology, Rouen university Hospital
Rouen, 76000
About this study
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.
- Conditions
- Healthy, Vascular Stiffness, Aging
- Being tested
- ivabradine, lactose capsule (placebo)
- Keywords
- ivabradine, heart rate, aging, visco-elasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ivabradineDrug
Also called Procoralan
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.
lactose capsule (placebo)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| ivabradine-placebo | Other | 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). Receives: Drug: ivabradine; Drug: lactose capsule (placebo) |
| placebo-ivabradine | Other | 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). Receives: Drug: ivabradine; Drug: lactose capsule (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in viscosity of the common carotid artery
Measured: 8 days after first administration of ivabradine or placebo
Secondary outcomes (8)
Change from baseline in diameter of the common carotid artery
Measured: 8 days after first administration of ivabradine or placebo
Change from baseline in intima-media thickness of the common carotid artery
Measured: 8 days after first administration of ivabradine or placebo
Change from baseline in carotid distensibility
Measured: 8 days after first administration of ivabradine or placebo
Change from baseline in carotid-femoral pulse wave velocity
Measured: 8 days after first administration of ivabradine or placebo
Change from baseline in plasma levels of biomarkers of endothelial function
Measured: 8 days after first administration of ivabradine or placebo
Change from baseline in peripheral and central pressures
Measured: 8 days after first administration of ivabradine or placebo
Change from baseline in Buckberg index
Measured: 8 days after first administration of ivabradine or placebo
Change from baseline in cardiac output
Measured: 8 days after first administration of ivabradine or placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study start3 Dec 2015
- Primary completion15 Jul 2019
- Study completion15 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederic Roca, MD, Principal investigator, University Hospital, RouenRobinson Joannides, MD,PhD, Study chair, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02584439
- Sponsor's protocol ID
- 2015/077/HP
- Other IDs
- 2015-002060-17, 2015
- Acronym
- BRADYVASC
- Status last verified
- Apr 2026
- First submitted
- 21 Oct 2015
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Franklin SS, Khan SA, Wong ND, Larson MG, Levy D. Is pulse pressure useful in predicting risk for coronary heart Disease? The Framingham heart study. Circulation. 1999 Jul 27;100(4):354-60. doi: 10.1161/01.cir.100.4.354.
PubMed 10421594Laurent S, Cockcroft J, Van Bortel L, Boutouyrie P, Giannattasio C, Hayoz D, Pannier B, Vlachopoulos C, Wilkinson I, Struijker-Boudier H; European Network for Non-invasive Investigation of Large Arteries. Expert consensus document on arterial stiffness: methodological issues and clinical applications. Eur Heart J. 2006 Nov;27(21):2588-605. doi: 10.1093/eurheartj/ehl254. Epub 2006 Sep 25.
PubMed 17000623Benetos A, Rudnichi A, Thomas F, Safar M, Guize L. Influence of heart rate on mortality in a French population: role of age, gender, and blood pressure. Hypertension. 1999 Jan;33(1):44-52. doi: 10.1161/01.hyp.33.1.44.
PubMed 9931080Lantelme P, Mestre C, Lievre M, Gressard A, Milon H. Heart rate: an important confounder of pulse wave velocity assessment. Hypertension. 2002 Jun;39(6):1083-7. doi: 10.1161/01.hyp.0000019132.41066.95.
PubMed 12052846Bellien J, Iacob M, Remy-Jouet I, Lucas D, Monteil C, Gutierrez L, Vendeville C, Dreano Y, Mercier A, Thuillez C, Joannides R. Epoxyeicosatrienoic acids contribute with altered nitric oxide and endothelin-1 pathways to conduit artery endothelial dysfunction in essential hypertension. Circulation. 2012 Mar 13;125(10):1266-75. doi: 10.1161/CIRCULATIONAHA.111.070680.
PubMed 22412088Fox K, Ford I, Steg PG, Tendera M, Ferrari R; BEAUTIFUL Investigators. Ivabradine for patients with stable coronary artery disease and left-ventricular systolic dysfunction (BEAUTIFUL): a randomised, double-blind, placebo-controlled trial. Lancet. 2008 Sep 6;372(9641):807-16. doi: 10.1016/S0140-6736(08)61170-8. Epub 2008 Aug 29.
PubMed 18757088Bellien J, Remy-Jouet I, Iacob M, Blot E, Mercier A, Lucas D, Dreano Y, Gutierrez L, Donnadieu N, Thuillez C, Joannides R. Impaired role of epoxyeicosatrienoic acids in the regulation of basal conduit artery diameter during essential hypertension. Hypertension. 2012 Dec;60(6):1415-21. doi: 10.1161/HYPERTENSIONAHA.112.201087. Epub 2012 Oct 22.
PubMed 23090775Reil JC, Tardif JC, Ford I, Lloyd SM, O'Meara E, Komajda M, Borer JS, Tavazzi L, Swedberg K, Bohm M. Selective heart rate reduction with ivabradine unloads the left ventricle in heart failure patients. J Am Coll Cardiol. 2013 Nov 19;62(21):1977-1985. doi: 10.1016/j.jacc.2013.07.027. Epub 2013 Aug 7.
PubMed 23933545Joannides R, Moore N, Iacob M, Compagnon P, Lerebours G, Menard JF, Thuillez C. Comparative effects of ivabradine, a selective heart rate-lowering agent, and propranolol on systemic and cardiac haemodynamics at rest and during exercise. Br J Clin Pharmacol. 2006 Feb;61(2):127-37. doi: 10.1111/j.1365-2125.2005.02544.x.
PubMed 16433867Boutouyrie P, Beaussier H, Achouba A, Laurent S; EXPLOR trialists. Destiffening effect of valsartan and atenolol: influence of heart rate and blood pressure. J Hypertens. 2014 Jan;32(1):108-14. doi: 10.1097/HJH.0000000000000014.
PubMed 24275838Tropeano AI, Boutouyrie P, Pannier B, Joannides R, Balkestein E, Katsahian S, Laloux B, Thuillez C, Struijker-Boudier H, Laurent S. Brachial pressure-independent reduction in carotid stiffness after long-term angiotensin-converting enzyme inhibition in diabetic hypertensives. Hypertension. 2006 Jul;48(1):80-6. doi: 10.1161/01.HYP.0000224283.76347.8c. Epub 2006 May 15.
PubMed 16702490Fox K, Ford I, Steg PG, Tardif JC, Tendera M, Ferrari R; SIGNIFY Investigators. Ivabradine in stable coronary artery disease without clinical heart failure. N Engl J Med. 2014 Sep 18;371(12):1091-9. doi: 10.1056/NEJMoa1406430. Epub 2014 Aug 31.
PubMed 25176136Drouin A, Gendron ME, Thorin E, Gillis MA, Mahlberg-Gaudin F, Tardif JC. Chronic heart rate reduction by ivabradine prevents endothelial dysfunction in dyslipidaemic mice. Br J Pharmacol. 2008 Jun;154(4):749-57. doi: 10.1038/bjp.2008.116. Epub 2008 Apr 14.
PubMed 18414390Williams B, Lacy PS, Thom SM, Cruickshank K, Stanton A, Collier D, Hughes AD, Thurston H, O'Rourke M; CAFE Investigators; Anglo-Scandinavian Cardiac Outcomes Trial Investigators; CAFE Steering Committee and Writing Committee. Differential impact of blood pressure-lowering drugs on central aortic pressure and clinical outcomes: principal results of the Conduit Artery Function Evaluation (CAFE) study. Circulation. 2006 Mar 7;113(9):1213-25. doi: 10.1161/CIRCULATIONAHA.105.595496. Epub 2006 Feb 13.
PubMed 16476843Bolduc V, Drouin A, Gillis MA, Duquette N, Thorin-Trescases N, Frayne-Robillard I, Des Rosiers C, Tardif JC, Thorin E. Heart rate-associated mechanical stress impairs carotid but not cerebral artery compliance in dyslipidemic atherosclerotic mice. Am J Physiol Heart Circ Physiol. 2011 Nov;301(5):H2081-92. doi: 10.1152/ajpheart.00706.2011. Epub 2011 Sep 16.
PubMed 21926346
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pharmacological Heart Rate Reduction on Visco-elastic Properties of the Arterial Wall (BRADYVASC)
- ClinicalTrials.gov ID
- NCT02584439
- Acronym / sponsor ID
- BRADYVASC / 2015/077/HP
- Conditions
- Healthy, Vascular Stiffness, Aging
- Keywords
- ivabradine, heart rate, aging, visco-elasticity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 3 Dec 2015 (actual)
- Primary completion
- 15 Jul 2019 (actual)
- Study completion
- 15 Jul 2019 (actual)
- First posted
- 22 Oct 2015 (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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ivabradine-placebo | Other | Drug: ivabradine, Drug: lactose capsule (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). |
| placebo-ivabradine | Other | Drug: ivabradine, Drug: lactose capsule (placebo)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). |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (22 listed)
- 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
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: ProcoralanIt is a cross over study with two arms : either ivabradine-placebo or placebo-ivabradine. The capsules containing the placebo or ivabradine are completely identical. | Drug | ivabradine-placebo, placebo-ivabradine |
| 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. | Drug | ivabradine-placebo, placebo-ivabradine |
Primary outcome
Change from baseline in viscosity of the common carotid artery
Time frame: 8 days after first administration of ivabradine or placebo
8 secondary outcomes
Change from baseline in diameter of the common carotid artery
Time frame: 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
Change from baseline in carotid distensibility
Time frame: 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
Change from baseline in plasma levels of biomarkers of endothelial function
Time frame: 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
Change from baseline in Buckberg index
Time frame: 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
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 17 Apr 2026.
- Background: PubMed 10421594Franklin SS, Khan SA, Wong ND, Larson MG, Levy D. Is pulse pressure useful in predicting risk for coronary heart Disease? The Framingham heart study. Circulation. 1999 Jul 27;100(4):354-60. doi: 10.1161/01.cir.100.4.354.
- Background: PubMed 17000623Laurent S, Cockcroft J, Van Bortel L, Boutouyrie P, Giannattasio C, Hayoz D, Pannier B, Vlachopoulos C, Wilkinson I, Struijker-Boudier H; European Network for Non-invasive Investigation of Large Arteries. Expert consensus document on arterial stiffness: methodological issues and clinical applications. Eur Heart J. 2006 Nov;27(21):2588-605. doi: 10.1093/eurheartj/ehl254. Epub 2006 Sep 25.
- Background: PubMed 9931080Benetos A, Rudnichi A, Thomas F, Safar M, Guize L. Influence of heart rate on mortality in a French population: role of age, gender, and blood pressure. Hypertension. 1999 Jan;33(1):44-52. doi: 10.1161/01.hyp.33.1.44.
- Background: PubMed 12052846Lantelme P, Mestre C, Lievre M, Gressard A, Milon H. Heart rate: an important confounder of pulse wave velocity assessment. Hypertension. 2002 Jun;39(6):1083-7. doi: 10.1161/01.hyp.0000019132.41066.95.
- Background: PubMed 22412088Bellien J, Iacob M, Remy-Jouet I, Lucas D, Monteil C, Gutierrez L, Vendeville C, Dreano Y, Mercier A, Thuillez C, Joannides R. Epoxyeicosatrienoic acids contribute with altered nitric oxide and endothelin-1 pathways to conduit artery endothelial dysfunction in essential hypertension. Circulation. 2012 Mar 13;125(10):1266-75. doi: 10.1161/CIRCULATIONAHA.111.070680.
- Background: PubMed 18757088Fox K, Ford I, Steg PG, Tendera M, Ferrari R; BEAUTIFUL Investigators. Ivabradine for patients with stable coronary artery disease and left-ventricular systolic dysfunction (BEAUTIFUL): a randomised, double-blind, placebo-controlled trial. Lancet. 2008 Sep 6;372(9641):807-16. doi: 10.1016/S0140-6736(08)61170-8. Epub 2008 Aug 29.
- Background: PubMed 23090775Bellien J, Remy-Jouet I, Iacob M, Blot E, Mercier A, Lucas D, Dreano Y, Gutierrez L, Donnadieu N, Thuillez C, Joannides R. Impaired role of epoxyeicosatrienoic acids in the regulation of basal conduit artery diameter during essential hypertension. Hypertension. 2012 Dec;60(6):1415-21. doi: 10.1161/HYPERTENSIONAHA.112.201087. Epub 2012 Oct 22.
- Background: PubMed 23933545Reil JC, Tardif JC, Ford I, Lloyd SM, O'Meara E, Komajda M, Borer JS, Tavazzi L, Swedberg K, Bohm M. Selective heart rate reduction with ivabradine unloads the left ventricle in heart failure patients. J Am Coll Cardiol. 2013 Nov 19;62(21):1977-1985. doi: 10.1016/j.jacc.2013.07.027. Epub 2013 Aug 7.
- Background: PubMed 16433867Joannides R, Moore N, Iacob M, Compagnon P, Lerebours G, Menard JF, Thuillez C. Comparative effects of ivabradine, a selective heart rate-lowering agent, and propranolol on systemic and cardiac haemodynamics at rest and during exercise. Br J Clin Pharmacol. 2006 Feb;61(2):127-37. doi: 10.1111/j.1365-2125.2005.02544.x.
- Background: PubMed 24275838Boutouyrie P, Beaussier H, Achouba A, Laurent S; EXPLOR trialists. Destiffening effect of valsartan and atenolol: influence of heart rate and blood pressure. J Hypertens. 2014 Jan;32(1):108-14. doi: 10.1097/HJH.0000000000000014.
- Background: PubMed 16702490Tropeano AI, Boutouyrie P, Pannier B, Joannides R, Balkestein E, Katsahian S, Laloux B, Thuillez C, Struijker-Boudier H, Laurent S. Brachial pressure-independent reduction in carotid stiffness after long-term angiotensin-converting enzyme inhibition in diabetic hypertensives. Hypertension. 2006 Jul;48(1):80-6. doi: 10.1161/01.HYP.0000224283.76347.8c. Epub 2006 May 15.
- Background: PubMed 25176136Fox K, Ford I, Steg PG, Tardif JC, Tendera M, Ferrari R; SIGNIFY Investigators. Ivabradine in stable coronary artery disease without clinical heart failure. N Engl J Med. 2014 Sep 18;371(12):1091-9. doi: 10.1056/NEJMoa1406430. Epub 2014 Aug 31.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Frederic Roca, MD principal investigator
University Hospital, Rouen
Robinson Joannides, MD,PhD study chair
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ivabradine in people with Healthy and Vascular Stiffness, run by University Hospital, Rouen at 1 site in France.
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 8 inclusion and 22 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 17 Apr 2026. 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 France. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Change from baseline in viscosity of the common carotid artery (time frame: 8 days after first administration of ivabradine or placebo). 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 NCT02584439, which also lists 18 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 17 Apr 2026.