Effect of heart rate and autonomic nervous system modulation on inflammatory state and peripheral vascular function in patients with type 2 diabetes. - ND

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-003773-41-IT

Enrollment

150

Registered

2008-08-01

Start date

2009-11-16

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

diabetes type 2 MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus

Interventions

Trade Name: PROCORALAN*56CPR RIV 5MG ALL/P Pharmaceutical Form: Coated tablet INN or Proposed INN: Ivabradine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pha

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Type 2 diabetes (American Diabetes Association definition) 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Cardiovascular disease Pharmacological therapy with insulin and/or Β-blockers Arterial blood pressure >140/90 mmHg Absence of informed consensus

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the effects of heart rate and autonomic nervous system modulation on inflammatory state and peripheral vascular function in patients with type 2 diabetes.;Secondary Objective: n.a.;Primary end point(s): Association of the effects of pharmacological treatments on heart rate and autonomic cardiac function with changes of inflammatory state and peripheral vascular function in patients with type 2 diabetes	—

Measure

Time frame

Main Objective: To evaluate the effects of heart rate and autonomic nervous system modulation on inflammatory state and peripheral vascular function in patients with type 2 diabetes.;Secondary Objective: n.a.;Primary end point(s): Association of the effects of pharmacological treatments on heart rate and autonomic cardiac function with changes of inflammatory state and peripheral vascular function in patients with type 2 diabetes

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Countries

Italy

Outcome results

None listed

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