Hypertension Clinical Trial
Official title:
Optimum and Stepped Care Standardised Antihypertensive Treatment With or Without Renal Artery Stenting in Patients With Documented Resistant Hypertension and Atherosclerotic Renal Artery Stenosis. ANDORRA TRIAL
The ANDORRA study is a, multicenter, prospective, open, randomized, controlled blinded endpoint trial (PROBE) comparing two treatment strategies (renal artery stenting + standardized and optimized medical treatment [SOMT] versus SOMT alone) of 12 months duration in patients with confirmed resistant hypertension (RH) and angiographically proven grade III unilateral or bilateral atherosclerotic renal artery stenosis (ARAS) ≥ 60%.
All eligible patients diagnosed with RH on office BP measurements and unilateral or bilateral
ARAS ≥60% on a non-invasive test (CT-angiogram or MR-angiogram) will receive a standardized
optimized triple antihypertensive treatment for 4 weeks. After 4 weeks, patients with
confirmed RH by ABPM (daytime ABPM ≥ 135 or 85 mmHg) and no clinically significant increase
in plasma creatinine from baseline (< 30%) will undergo a renal angiogram to confirm the
degree of ARAS ≥60% in diameter.
Immediately after the renal angiography, all patients will undergo flow fractional reserve
(FFR) measurements. Once FFR measurements have been done and all criteria are met, patients
will be randomized in the angiography room to either renal artery stenting + SOMT (stenting
group) versus SOMT (control group) whatever the results of the FFR in a 1:1 ratio. Both
groups will continue the SOMT during follow-up.
The SOMT will be prescribed from the inclusion visit until the 6 month-visit after
randomization. After randomization, the antihypertensive treatment will be adapted according
to the results of home BP (HBP) at monthly visits starting 2 months after randomization.
After the 6-month visit, the antihypertensive treatment adaptation will be left at the
discretion of the physician in charge of the patient.
;
| 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 |