Arterial HypertensionPhase 4ITEMNCT00559286
Effect of the Known Antihypertensive Drug Telmisartan on Red Blood Cells and Circulation in the Smallest Blood Vessels
A Phase 4 study testing Telmisartan in people with Arterial Hypertension and Diabetes Mellitus Type 2 IRC or NIR, run by RWTH Aachen University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Arterial Hypertension, Diabetes Mellitus Type 2 IRC or NIR
- What is being tested?
- Telmisartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2007to Jan 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of the Angiotensin Receptor Blocker Telmisartan on the Red Blood Cell Function and the Microcirculatory Perfusion
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.
Read the 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.
- Being tested
- Telmisartan
- Keywords
- perfusion, microcirculation, RBC function, NO metabolism, AT receptor blocker
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelmisartanDrug
application of 80mg or 20mg Telmisartan per day for 30 days
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | treatment with 80 mg Telmisartan per day for 30 days Receives: Drug: Telmisartan |
| B | Active comparator | treatment with 20mg Telmisartan per day for 30 days Receives: Drug: Telmisartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Elongation-Index (EI) Method: To determine the elongation index (EI) we use the Laser assisted optical rotational cell analyzer (Lorrca).
Measured: after 30 days of treatment with study drug/control
Secondary outcomes (4)
Improvement of microcirculatory perfusion (using laser doppler measurement)
Measured: after 30 days treatment
Improvement of endothelial function (using ultrasound measurements during flow mediated dilation)
Measured: after 30 days treatment
Increase in the total blood born NO pool (using reductive gase phase chemiluminescence
Measured: after 30 days treatment
Decrease of RBC aggregation (using Laser assisted optical rotational cell analyzer (Lorrca)
Measured: after 30 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2007 (estimated)
- Study startDec 2007
- Primary completionJan 2009
- Study completionJan 2009
Why it stopped: logistic reasons, patients could not be recruited
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Collaborators
- CTCA, Heidelberg University, Bayer
- Investigators
- Malte Kelm, MD, Univ.Prof., Principal investigator, Department of Cardiology, Angiology, Pulmonary Diseases and cardiologic critical care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00559286
- Sponsor's protocol ID
- AIX-MK-01
- Other IDs
- EUDRA CT No 2007-002765-12
- Acronym
- ITEM
- Status last verified
- Jan 2009
- First submitted
- 15 Nov 2007
- Last updated
- 29 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Angiotensin Receptor Blocker Telmisartan on the Red Blood Cell Function and the Microcirculatory Perfusion
- ClinicalTrials.gov ID
- NCT00559286
- Acronym / sponsor ID
- ITEM / AIX-MK-01
- Keywords
- perfusion, microcirculation, RBC function, NO metabolism, AT receptor blocker
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: logistic reasons, patients could not be recruited
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Collaborators
- CTCA, Heidelberg University, Bayer
- Study start
- Dec 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 16 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Telmisartantreatment with 80 mg Telmisartan per day for 30 days |
| B | Active comparator | Drug: Telmisartantreatment with 20mg Telmisartan per day for 30 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (16 listed)
- Serve heart failure
- Serve aortic valve stenosis or hypertrophy obstructive cardiomyopathy
- Relevant cardiac arrhythmias
- Acute myocardial infarction within the last 4 weeks
- renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telmisartanapplication of 80mg or 20mg Telmisartan per day for 30 days | Drug | A, B |
Primary outcome
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
4 secondary outcomes
Improvement of microcirculatory perfusion (using laser doppler measurement)
Time frame: after 30 days treatment
Improvement of endothelial function (using ultrasound measurements during flow mediated dilation)
Time frame: after 30 days treatment
Increase in the total blood born NO pool (using reductive gase phase chemiluminescence
Time frame: after 30 days treatment
Decrease of RBC aggregation (using Laser assisted optical rotational cell analyzer (Lorrca)
Time frame: after 30 days of treatment
Results and safety
The study was stopped early (reason given: logistic reasons, patients could not be recruited). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malte Kelm, MD, Univ.Prof. principal investigator
Department of Cardiology, Angiology, Pulmonary Diseases and cardiologic critical care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Telmisartan in people with Arterial Hypertension and Diabetes Mellitus Type 2 IRC or NIR, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: logistic reasons, patients could not be recruited). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2009.