Influence of the angiotensin receptor blocker Telmisartan on the red blood cell function and the microcirculatory perfusion (ITEM) - ITEM

Phase 1

• Conditions: MedDRA version: 9.1Level: LLTClassification code 10012601Term: Diabetes mellitus; arterial hypertensiondiabetes mellitus type 2; MedDRA version: 9.1Level: LLTClassification code 10020775Term: Hypertension arterial

• Registration Number: EUCTR2007-002765-12-DE
• Lead Sponsor: RWTH Aachen University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-07-06
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

Men older than 18 years
Diabetes mellitus type 2 defined according to the criteria of the American Diabetes Association
Arterial hypertension defined according to the criteria of the Joint National Committees (JNC 7)
Given informed consent
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Severe heart failure
Severe aortic valve stenosis or hypertrophic obstructive cardiomyopathy
Relevant cardiac arrhythmias
Acute myocardial infarction within the last 4 weeks
Renal failure
Bilateral renal artery stenosis
Liver diseases
Primary hyperaldosteronism
Orthostatic hypotension (systolic blood pressure < 100 mmHg)
Hypokalemia, hyponatremia, hypercalcemia, symptomatic hyperuricemia Hyponatriämie, Hyperkalziämie und symptomatische Hyerurikämie
Inflammatory disease
Malignant disease
Previous intolerance to AT1 receptor antagonists and/or sulfonamides
Current therapy with insulin sensitizer
Current therapy with digoxin
known abuse of alcohol or drugs

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The regulation intake of telmisartan results in an increase of red blood cell deformability in patients with arterial hypertension and diabetes mellitus.;Secondary Objective: The regulation intake of telmisartan results in an increase of the microcirculatory perfusion in patients with arterial hypertension and diabetes mellitus.;Primary end point(s): Increase in red blood cell deformability