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Clinical study to investigate the effect of heart rate reduction with the drug ivabradine on the function of large blood vessels in patients with angina pectoris (coronary heart disease).

A randomised, placebo controlled, double blind, cross-over, single center clinical Study to investigate the effect of heart rate reduction with ivabradine on endothelial function and vascular stiffness in patients with stable coronary heart disease. -

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-001989-15-DE
Enrollment
Unknown
Registered
2012-05-18
Start date
2012-09-17
Completion date
Unknown
Last updated
2012-09-25

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

Conditions

Stable coronary heart disease. MedDRA version: 14.1 Level: LLT Classification code 10068617 Term: Coronary heart disease System Organ Class: 10007541 - Cardiac disorders

Interventions

Trade Name: Procoralan® Pharmaceutical Form: Film-coated tablet INN or Proposed INN: IVABRADINE CAS Number: 155974-00-8 Concentration unit: mg milligram(s) Concentration type: equal Concentration num

Sponsors

Universität des Saarlandes
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -Male and female patients -Age > 18 years old -Resting heart rate = 70 bpm -Sinus rhythm -Chronic stable angina pectoris -Coronary heart disease detected by coronary angiography -Written informed consent to participate in the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 35 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15

Exclusion criteria

Exclusion criteria: -Acute coronary syndrome / myocardial infarction -CAD treated best by surgical coronary bypass grafting -Stroke / TIA -Resting heart rate < 70/min -Indwelling pacemaker, AICD, metallic implants -Valvular heart disease with indication for surgical intervention -Caridac rhythm other than sinus -Uncontrolled arterial hypertension -Preexisting medication with study drug -Symptomatic PAD -Known diabetes mellitus -Pre-menopausal women

Design outcomes

Primary

MeasureTime frame
Main Objective: To test the hypothesis that heart rate reduction induced by the I(f)-channel inhibitor ivabradine improves endothelial function and central vascular compliance in patients with chronic stable coronary artery disease. ;Secondary Objective: No secondary objectives;Primary end point(s): -Aortic distensibility -Pulse wave velocity -Brachial endothelial function ;Timepoint(s) of evaluation of this end point: Evaluation of all avove mentioned Endpoints at: -Baseline -Months 6 -Month 12—

Secondary

MeasureTime frame
Secondary end point(s): No;Timepoint(s) of evaluation of this end point: Serum and Plasma markers for oxidative stress and inflammation—

Countries

Germany

Contacts

Public ContactAngelika Knoll

Universität des Saarlandes

Angelika.Knoll@uks.eu004968411623412

Outcome results

None listed

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