Effect of the Known Antihypertensive Drug Telmisartan on Red Blood Cells and Circulation in the Smallest Blood Vessels

NCT00559286 | Terminated Phase 4 DMC

• 2 other identifiers: AIX-MK-01EUDRA CT No 2007-002765-12
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The hypothesis of the presented study is: Telmisartan induces an increase of eNOS activity in RBC resulting in an enhanced intravascular NO bioavailability, an ameliorated RBC deformability and a reduction of RBC and platelet aggregation. This could be a potential mechanism of the improvement of microcirculatory disorders, especially in patients with diabetes mellitus and arterial hypertension, treated with Telmisartan.

Conditions

Arterial Hypertension; Diabetes Mellitus Type 2 IRC or NIR

Keywords

perfusion; microcirculation; RBC function; NO metabolism; AT receptor blocker

Outcome Measures

Primary Outcomes (1)

• Changes in Elongation-Index (EI) Method: To determine the elongation index (EI) we use the Laser assisted optical rotational cell analyzer (Lorrca).

  after 30 days of treatment with study drug/control

Secondary Outcomes (4)

• Improvement of microcirculatory perfusion (using laser doppler measurement)

  after 30 days treatment

• Improvement of endothelial function (using ultrasound measurements during flow mediated dilation)

  after 30 days treatment

• Increase in the total blood born NO pool (using reductive gase phase chemiluminescence

  after 30 days treatment

• Decrease of RBC aggregation (using Laser assisted optical rotational cell analyzer (Lorrca)

  after 30 days of treatment

Study Arms (2)

A

EXPERIMENTAL

treatment with 80 mg Telmisartan per day for 30 days

Drug: Telmisartan

B

ACTIVE COMPARATOR

treatment with 20mg Telmisartan per day for 30 days

Drug: Telmisartan

Interventions

Telmisartan DRUG

application of 80mg or 20mg Telmisartan per day for 30 days

A; B

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 Committtees (JNC 7)
• Given informed consent

You may not qualify if:

• Serve heart failure
• Serve aortic valve stenosis or hypertrophy 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 \<100mmHg)
• hypokalemia, hyponatremia, hypercalcemia, symptomatic hyperuricemia
• inflammatory disease
• malignant disease
• previous intolerance to AT1 receptor antagonists and/or sulfonamides
• current therapy with insulin sensitizer
• current therapy with digoxin

Sponsors & Collaborators

• RWTH Aachen University: lead
• CTCA: collaborator
• Heidelberg University: collaborator
• Bayer: collaborator

Study Sites (1)

University Hospital

Aachen, North Rhine-Westphalia, 52074, Germany

Location

MeSH Terms

Conditions

Hypertension

Interventions

Telmisartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Malte Kelm, MD, Univ.Prof.

  Department of Cardiology, Angiology, Pulmonary Diseases and cardiologic critical care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 15, 2007
• First Posted: November 16, 2007
• Study Start: December 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: January 29, 2009

Record last verified: 2009-01

Locations

DE (1)