Hypertension Clinical Trial
— TELNEBOfficial title:
Comparative Study of the Effects of Telmisartan and Nebivolol on 24-h Ambulatory Blood Pressure and Arterial Stiffness in Patients With Arterial Hypertension
Τhe effectiveness of newer angiotensin-II receptor blockers and cardioselective
beta-adrenergic blockers in treatment of arterial hypertension and in improvement of
arterial stiffness has been established in previous studies among the hypertensive
population. The present study is a comparison of the performance of two drugs, telmisartan
and nebivolol, in 24h ambulatory blood pressure values and in the degree of arterial
stiffness of patients with stage I arterial hypertension.
Measurements will be carried out with the use of 24-h ambulatory blood pressure measurement
devices and the method of pulse-wave velocity analysis. The effects of telmisartan and
nebivolol are going to be compared for a total time period of 12 months.
The aim of this project is to determine whether the expected decrease in arterial stiffness
of subjects with stage I arterial hypertension can be attributed to the blood pressure fall
solely, or to other factors as well. These factors are possibly dependent on the action of
these drugs on the renin-angiotensin II-aldosterone system (RAAS) or on peripheral
vasodilatory actions.
The present study is going to be the first comparative test of the anti-hypertensive effects
of the two pharmaceutical substances in 12 months' time, and of the elimination of total
cardiovascular risk in terms of primary prevention of cardiovascular attacks.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | January 2017 |
Est. primary completion date | January 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: The final selection of the sample of 80 patients diagnosed with stage
I arterial hypertension will be based on the ABPM results (24h SBP/DBP = 130/80 mm Hg). Exclusion Criteria: Patients who present with normal ABPM values at the end of the 3-month period will be excluded from the study. Subjects diagnosed with white-coat hypertension [increased office BP values (SBP/DBP = 140/90 mm Hg) combined with normal ABPM values (24h SBP/DBP < 130/80 mm Hg)] will also be excluded from the study. All subjects with contra-indications for submission of drugs used in the research protocol are going to be excluded from the study. The following categories of patients will not participate in the research: renal failure, hepatic failure, renal artery stenosis, bronchial asthma, vasoconstrictive (Prinzmetal's) angina, hypertrophic cardiomyopathy, aortic valve stenosis, mitral valve stenosis, sinus tachycardia, sinus bradycardia, sick sinus syndrome, Wolff-Parkinson-White syndrome, chronic atrial fibrillation, second and third degree atrioventricular block, right heart failure due to pulmonary hypertension, pheochromocytoma, peripheral artery disease. Pregnant and nursing women will be excluded from the study (history and pregnancy test). |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Greece | Hypertension-ABPM Center 3rd department of Internal Medicine | Thessaloniki |
Lead Sponsor | Collaborator |
---|---|
Aristotle University Of Thessaloniki |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in 24h blood pressure | Change in 24h BP values in patients with stage I arterial hypertension treated with telmisartan and nebivolol | 1,6,12 months | No |
Primary | Change from baseline in arterial stiffness | Change in arterial stiffness in patients with stage I arterial hypertension treated with telmisartan and nebivolol | 1,6,12 months | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT04591808 -
Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia
|
Phase 3 | |
Recruiting |
NCT04515303 -
Digital Intervention Participation in DASH
|
||
Completed |
NCT05433233 -
Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension
|
N/A | |
Completed |
NCT05491642 -
A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses
|
Phase 1 | |
Completed |
NCT03093532 -
A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Completed |
NCT05529147 -
The Effects of Medication Induced Blood Pressure Reduction on Cerebral Hemodynamics in Hypertensive Frail Elderly
|
||
Recruiting |
NCT06363097 -
Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
|
||
Recruiting |
NCT05976230 -
Special Drug Use Surveillance of Entresto Tablets (Hypertension)
|
||
Completed |
NCT06008015 -
A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" Under Fed Conditions in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT05387174 -
Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period
|
N/A | |
Completed |
NCT04082585 -
Total Health Improvement Program Research Project
|
||
Recruiting |
NCT05121337 -
Groceries for Black Residents of Boston to Stop Hypertension Among Adults Without Treated Hypertension
|
N/A | |
Withdrawn |
NCT04922424 -
Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men
|
Phase 1 | |
Active, not recruiting |
NCT05062161 -
Sleep Duration and Blood Pressure During Sleep
|
N/A | |
Completed |
NCT05087290 -
LOnger-term Effects of COVID-19 INfection on Blood Vessels And Blood pRessure (LOCHINVAR)
|
||
Not yet recruiting |
NCT05038774 -
Educational Intervention for Hypertension Management
|
N/A | |
Completed |
NCT05621694 -
Exploring Oxytocin Response to Meditative Movement
|
N/A | |
Completed |
NCT05688917 -
Green Coffee Effect on Metabolic Syndrome
|
N/A | |
Recruiting |
NCT05575453 -
OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure
|
N/A |