Effect of the Known Antihypertensive Drug Telmisartan on... | NCT00559286

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

NCT00559286

Sponsor

RWTH Aachen University

Status

Terminated

Last Update Posted

Jan 29, 2009Estimated

Enrollment

40Estimated

Phase

Phase 4

Conditions

Arterial Hypertension
Diabetes Mellitus Type 2 IRC or NIR

Interventions

Telmisartan

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EUDRA CT No 2007-002765-12

Status Module

Record Verification Date

Jan 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

logistic reasons, patients could not be recruited

Expanded Access Info

Start Date

Dec 2007

Primary Completion Date

Jan 2009Actual

Completion Date

Jan 2009Actual

First Submitted Date

Nov 15, 2007

First Submission Date that Met QC Criteria

Nov 15, 2007

First Posted Date

Nov 16, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 28, 2009

Last Update Posted Date

Jan 29, 2009Estimated

Name	Class
CTCA	UNKNOWN
Heidelberg University	OTHER
Bayer	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Telmisartan	Drug	application of 80mg or 20mg Telmisartan per day for 30 days	A B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Malte Kelm, MD, Univ.Prof.	Department of Cardiology, Angiology, Pulmonary Diseases and cardiologic critical care	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital		Aachen	North Rhine-Westphalia	52074	Germany

ID	Term
D006973	Hypertension

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D000077333	Telmisartan

Ancestor Terms

ID	Term
D001713	Biphenyl Compounds
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

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Browse Branches

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