Hypertension Clinical Trial
Official title:
Effect of Aliskiren 300mg and Hydrochlorothiazide 25mg on Kidney Oxygenation in Patients With Stage 1 and 2 Hypertension: a BOLD-MRI Study
The goal of this project is to evaluate the chronic effect (8 weeks) of RASILEZ 300mg (aliskiren) on renal tissue oxygenation in patients with stage 1-2 hypertension, and to compare the chronic effect (8 weeks) of RASILEZ 300mg (aliskiren) on renal tissue oxygenation in patients with stage 1-2 hypertension with these effects with those of ESIDREX 25mg (hydrochlorothiazide).
36 patients with arterial hypertension stage 1-2 (blood pressure: 140/90 and 180/110 mm Hg)
will be included in this study and randomized to two groups of 18 patients each: one group
will receive RASILEZ 300mg (aliskiren) and one group ESIDREX 25mg (hydrochlorothiazide).
After a two week washout of antihypertensive drugs, baseline and the chronic effect (8 week
study drug) of each group will be studied with precise renal hemodynamic measurements (inulin
clearance, PAH renal plasma and blood flow, sodium and endogenous lithium excretion, plasma
renin, plasma aldosterone, urinary sodium and potassium) and assessment of renal oxygenation
with BOLD-MRI (blood oxygen level detection - magnetic resonance imaging).
Drug therapy will be started with an initial 2 weeks on Rasilez 150 mg or HCTZ 12.5 mg
followed by a titration to 300 mg Rasilez and 25 mg HCTZ if the treatment is well tolerated.
In both groups: a first baseline measurements will be performed before initiating therapy and
a second after 8 weeks of treatment (24h after last drug intake) to assess the chronic
effect.
Patients already on treatment with antihypertensive drugs can be included in this study, but
will undergo a 'wash-out' period of two weeks. After obtaining informed consent, baseline
physical examination and office blood pressure measurement will be performed. Office blood
pressure will be measured according to the guidelines of the European Society on Hypertension
and European Society of Cardiology (ESH-ESC practice guidelines) by an experienced physician.
Moreover, patients will measure their home blood pressure twice daily: after 5 minutes of
sitting quietly, three measures spaced by 1-2 minutes will be taken in the morning and in the
evening. For this purpose, an Omron 705 IT device will be provided to the participants; this
device has been widely tested in clinical practice and has been validated for use in clinical
studies (12).
Throughout the study, the participants will continue his/her regular diet. The goal should be
to keep the salt intake as stable as possible during the study, since salt intake alters the
R2* signal. Salt intake will be verified each time before BOLD-MRI measurement by a 24h urine
collection (dosing volume, creatinine- and sodium-concentration).
To complete the study we decid to test the acute effect of aliskiren 300mg and Esidrex
(hydrochlorthiazide) 25mg in 6 healthy volunteers. We will measure the cortical and medullary
R2* signal before drug intake and 3 hours after drug administration. Each participant will
take the two drugs in a randomised crossover design. A wash-out period of two week between
the two administration will be implemented.
;
| 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 |
NCT05976230 -
Special Drug Use Surveillance of Entresto Tablets (Hypertension)
|
||
| Recruiting |
NCT06363097 -
Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
|
||
| 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 | |
| Not yet recruiting |
NCT05038774 -
Educational Intervention for Hypertension Management
|
N/A | |
| Completed |
NCT05087290 -
LOnger-term Effects of COVID-19 INfection on Blood Vessels And Blood pRessure (LOCHINVAR)
|
||
| 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 |