Effects of ivabradine on vascular function in individuals at increased risk of developing cardiovascular disease and with impaired endothelial function

Effects of ivabradine on vascular function in individuals at increased risk of developing cardiovascular disease and with impaired endothelial function An international, multicentre, randomised, double-blind, placebo-controlled study over 12 weeks.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-000215-89-IT

Enrollment

340

Registered

2013-04-23

Start date

2013-06-14

Completion date

Unknown

Last updated

2014-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular disease MedDRA version: 14.1 Level: LLT Classification code 10007648 Term: Cardiovascular disease, unspecified System Organ Class: 100000004849

Interventions

Trade Name: Procoralan Product Name: S16257 Product Code: S16257 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: IVABRADINE CAS Number: 155974-00-8 Current Sponsor code: S16257 Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Men or postmenopausal women of any ethnic origin aged between 21 and 74 years - In sinus rhythm with resting HR at least 75 bpm - At increased risk of subsequent cardiovascular disease (documented by the presence of at least two cardiovascular risk factors such as diabetes, hypertension, smoking, hypercholesterolemia) and impaired FMD (=65 years) yes F.1.3.1 Number of subjects for this age range 70

Exclusion criteria

Exclusion criteria: - Previous diagnosis of coronary heart disease - Previous diagnosis of heart failure or current clinical signs or symptoms in keeping with a diagnosis of heart failure - History of cerebrovascular or peripheral arterial disease - Uncontrolled hypertension - Chronic infectious or inflammatory disease - Chronic Obstructive Pulmonary Disease (COPD) treated with inhaled bronchodilators - Malignancy - Current therapy with nicorandil, nitrate, insulin - Contra-indication to ivabradine

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate the beneficial effect of ivabradine compared with placebo on endothelial function as measured by flow mediated dilation (FMD) of the brachial artery at 12 weeks of treatment;Secondary Objective: To investigate the effect of ivabradine compared with placebo on: - biomarkers of endothelial function and cardiovascular risk, - resting heart rate. ;Primary end point(s): Absolute percentage change in FMD of the brachial artery;Timepoint(s) of evaluation of this end point: At baseline and at the end of the study (W012)	—

Measure

Time frame

Main Objective: To demonstrate the beneficial effect of ivabradine compared with placebo on endothelial function as measured by flow mediated dilation (FMD) of the brachial artery at 12 weeks of treatment;Secondary Objective: To investigate the effect of ivabradine compared with placebo on: - biomarkers of endothelial function and cardiovascular risk, - resting heart rate. ;Primary end point(s): Absolute percentage change in FMD of the brachial artery;Timepoint(s) of evaluation of this end point: At baseline and at the end of the study (W012)

—

Secondary

Measure	Time frame
Secondary end point(s): - Change in levels of biomarkers of endothelial function and cardiovascular risk - Heart rate change;Timepoint(s) of evaluation of this end point: - At baseline and at the end of the study (W012) for the biomarkers - From baseline to the end of the study for the heart rate	—

Countries

France, Germany, Italy, Netherlands, Switzerland, United Kingdom

Contacts

Public ContactClinical Studies Department

Institut de Recherches Internationales Servier

clinicaltrials@servier.com+33155 72 43 66

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026