Effect of the Known Antihypertensive Drug Telmisartan on Red Blood Cells and Circulation in the Smallest Blood Vessels (ITEM)
Primary Purpose
Arterial Hypertension, Diabetes Mellitus Type 2 IRC or NIR
Status
Terminated
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Telmisartan
Sponsored by
About this trial
This is an interventional treatment trial for Arterial Hypertension focused on measuring perfusion, microcirculation, RBC function, NO metabolism, AT receptor blocker
Eligibility Criteria
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 Committtees (JNC 7)
- Given informed consent
Exclusion Criteria:
- 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
- known abuse of alcohol or drugs
Sites / Locations
- University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A
B
Arm Description
treatment with 80 mg Telmisartan per day for 30 days
treatment with 20mg Telmisartan per day for 30 days
Outcomes
Primary Outcome Measures
Changes in Elongation-Index (EI) Method: To determine the elongation index (EI) we use the Laser assisted optical rotational cell analyzer (Lorrca).
Secondary Outcome Measures
Improvement of microcirculatory perfusion (using laser doppler measurement)
Improvement of endothelial function (using ultrasound measurements during flow mediated dilation)
Increase in the total blood born NO pool (using reductive gase phase chemiluminescence
Decrease of RBC aggregation (using Laser assisted optical rotational cell analyzer (Lorrca)
Full Information
NCT ID
NCT00559286
First Posted
November 15, 2007
Last Updated
January 28, 2009
Sponsor
RWTH Aachen University
Collaborators
CTCA, Heidelberg University, Bayer
1. Study Identification
Unique Protocol Identification Number
NCT00559286
Brief Title
Effect of the Known Antihypertensive Drug Telmisartan on Red Blood Cells and Circulation in the Smallest Blood Vessels
Acronym
ITEM
Official Title
Influence of the Angiotensin Receptor Blocker Telmisartan on the Red Blood Cell Function and the Microcirculatory Perfusion
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Terminated
Why Stopped
logistic reasons, patients could not be recruited
Study Start Date
December 2007 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
RWTH Aachen University
Collaborators
CTCA, Heidelberg University, Bayer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Recently, it could be shown that the renin-angiotensin-system (RAS) influences different signal transduction pathways within the red blood cells (RBC). This includes the Na+/H+ exchange activity, the Ca2+-ATP-ase mediated Ca2+efflux, the erythropoietin- dependent production of RBC, the RBC deformability, RBC aggregation and the interaction of RBC and platelets. Recent studies and experiments, done by our group, focus on the oxidative and nitrosative metabolism of NO within the blood. The interactions of the RAS and endothelial NO are well known and described in detail. Based on a wide experience in this research field of NO metabolism, we characterized recently an active endothelial-type NO-synthase in RBC on the biochemical, functional and molecular level. Erythrocyte-derived NO formation serves important regulatory functions essential for adequate passage of blood through the vasculature. Here we aimed to treat patients with diabetes mellitus and arterial hypertension with Telmisartan as an angiotensin receptor antagonist. Efficacy parameters studied in this study should be: i) RBC deformability, RBC aggregation, ii) RBC dependent production of nitric oxide as well as detection of eNOS activity in RBC and iii) indices of microcirculatory perfusion. This project could broaden the view of effects of Telmisartan in the treatment of microcirculatory disorders in patients with diabetes mellitus and arterial hypertension, who exhibit a reduced NO bioavailability and RBC function.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterial Hypertension, Diabetes Mellitus Type 2 IRC or NIR
Keywords
perfusion, microcirculation, RBC function, NO metabolism, AT receptor blocker
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
treatment with 80 mg Telmisartan per day for 30 days
Arm Title
B
Arm Type
Active Comparator
Arm Description
treatment with 20mg Telmisartan per day for 30 days
Intervention Type
Drug
Intervention Name(s)
Telmisartan
Intervention Description
application of 80mg or 20mg Telmisartan per day for 30 days
Primary Outcome Measure Information:
Title
Changes in Elongation-Index (EI) Method: To determine the elongation index (EI) we use the Laser assisted optical rotational cell analyzer (Lorrca).
Time Frame
after 30 days of treatment with study drug/control
Secondary Outcome Measure Information:
Title
Improvement of microcirculatory perfusion (using laser doppler measurement)
Time Frame
after 30 days treatment
Title
Improvement of endothelial function (using ultrasound measurements during flow mediated dilation)
Time Frame
after 30 days treatment
Title
Increase in the total blood born NO pool (using reductive gase phase chemiluminescence
Time Frame
after 30 days treatment
Title
Decrease of RBC aggregation (using Laser assisted optical rotational cell analyzer (Lorrca)
Time Frame
after 30 days of treatment
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Committtees (JNC 7)
Given informed consent
Exclusion Criteria:
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
known abuse of alcohol or drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malte Kelm, MD, Univ.Prof.
Organizational Affiliation
Department of Cardiology, Angiology, Pulmonary Diseases and cardiologic critical care
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Aachen
State/Province
NRW
ZIP/Postal Code
52074
Country
Germany
12. IPD Sharing Statement
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Effect of the Known Antihypertensive Drug Telmisartan on Red Blood Cells and Circulation in the Smallest Blood Vessels
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