HypertensionPhase 4ANDORRANCT02539810
Renal Artery Stenting in Patients With Documented Resistant Hypertension and Atherosclerotic Renal Artery Stenosis (ANDORRA)
A Phase 4 study testing Renal artery Angioplasty plus stenting. and Anti hypertensive, statin and antiplatelet medication. in people with Hypertension and Hypertension Resistant to Conventional Therapy, run by Assistance Publique - Hôpitaux de Paris at 15 sites in France.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Hypertension, Hypertension Resistant to Conventional Therapy, Angiographically Proven Grade III Unilateral or Bilateral Atherosclerotic Renal Artery Stenosis (ARAS) Greater Than or Equal to 60 Percent
- What is being tested?
- Renal artery Angioplasty plus stenting. and Anti hypertensive, statin and antiplatelet medication.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 15 sitesFrance
- Study dates
- Sep 2015to Jul 2017
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 40 to 80 Years
- Men or women
- Supine office BP ≥ 140 and/or 90 mmHg at screening despite a stable medication regimen including full tolerated doses of 3 or more anti-hypertensive treatments of different classes, including a diuretic.
- Unilateral or bilateral ARAS of a main renal artery ≥60% diagnosed by renal CT- angiogram (or MR-angiogram if there is a contraindication to perform CT) performed in the year before
- One or two functional kidney(s) ≥ 70 mm in pole-to-pole length
- eGFR ≥ 20 ml/min/1.73 m² (MDRD formula)
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- Signed informed consent
- Social insurance coverage
- RH confirmed by daytime ABPM ≥ 135 or 85 mmHg after 1 month treatment with SOMT at Visit V1.
- Unilateral or bilateral ARAS of a main renal artery ≥ 60% confirmed on renal angiogram by Quantitative Vascular Analysis (QVA)
- Increase in plasma creatinine < 30% after 4-week SOMT
Who cannot join
- Fibromuscular dysplasia of renal artery or other non-atherosclerotic renal artery stenosis
- Other secondary form of hypertension excluded on the basis of a clinical, hormonological and/or imaging work-up
- Restenosis after a previous renal angioplasty or stenting
- Only a stenosis of an accessory renal artery supplying <1/2 of the ipsilateral renal parenchyma
- Additional indication of ARAS stenting (Malignant hypertension, ≥ 30% increase in plasma creatinine after renin angiotensin system (RAS) blocker or after RAS blocker and diuretic administration, flash pulmonary edema)
- Kidney pole-to-pole length < 70 mm
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- Vascular disease precluding access for stenting
- Abrupt vessel closure or dissection after diagnostic angiography
- Contraindication to renal artery stenting according the notice for use of the stents
- eGFR < 20 ml/min/1.73 m² (MDRD)
- History of transient ischemic accident (TIA) or cerebrovascular accident (CVA) during the 3 months prior to visit 1
- History of acute heart failure or heart failure (NYHA class III-IV) within the 3 months prior to visit 1
- History of myocardial infarction, unstable angina, coronary bypass or percutaneous coronary angioplasty during the 3 months prior to visit 1
- Abdominal aortic aneurysm with indication for surgery or EVAR (Endovascular Aneurysm Repair)
- Known history of cholesterol embolism
- Brachial circumference of ≥ 42 cm
- Severe contrast media allergy, not amenable to pre-treatment
- Allergy to aspirin or clopidogrel
- Atrial fibrillation
- Comorbid condition causing life expectancy ≤ 3 years
- Unlikely to co-operate in the study and/or poor compliance anticipated by the investigator
- Participant not affiliated to the French social security
- Pregnancy or breastfeeding
- Guardianship for incapacity
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
France15 sites
Hopital Saint Andre - CHU Bordeaux
Bordeaux, Gironde, 33075
CHU Clermont-Ferrand
Clermont-Ferrand, Puy-de-Dome, 63000
Hopital Arthur Gardiner
Dinard, Ille-et-Vilaine, 35800
Groupe Hospitalier Mutualiste
Grenoble, Isere, 38028
Hopital Michallon - CHU Grenoble
La Tronche, Isere, 38700
Hopital Cardiologique - CHRU Lille
Lille, Nord, 59037
Hopital de la Croix-Rousse - CHU Lyon
Lyon, Rhone, 69004
Hopital Lapeyronie - CHU Montpellier
Montpellier, Herault, 34295
Hopital Pasteur
Nice, Alpes-Maritimes, 06002
Hopital de la Pitie Salpetriere
Paris, 75013
Hopital Europeen Georges Pompidou (HEGP)
Paris, 75015
Hopital Pontchaillou - CHU Rennes
Rennes, Ille-et-Vilaine, 35033
Hopital Rangueil - CHU Toulouse
Toulouse, Haute-Garonne, 31059
Institut Lorrain du Cœur et des Vaisseaux Louis Mathieu
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54500
Hopital de Brabois
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54511
About this study
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%.
Read the detailed description
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.
- Conditions
- Hypertension, Hypertension Resistant to Conventional Therapy, Angiographically Proven Grade III Unilateral or Bilateral Atherosclerotic Renal Artery Stenosis (ARAS) Greater Than or Equal to 60 Percent
- Being tested
- Renal artery Angioplasty plus stenting., Anti hypertensive, statin and antiplatelet medication.
- Medical subject headings
- Hypertension, Hypertension Resistant to Conventional Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal artery Angioplasty plus stenting.Device
Also called RA Stent
renal artery stenting
Anti hypertensive, statin and antiplatelet medication.Drug
Also called SOMT
Slow release indapamide 1.5 mg/d (or furosemide 40 mg/d if eGFR is < 30 mL/min/1.73m²) + irbesartan 300 mg/d + amlodipine 10 mg/d + aspirin 75 mg/d (or clopidogrel 75 mg/d in case of allergy or gastrointestinal intolerance to aspirin) + atorvastatin 20 mg/d. After randomization, bisoprolol 10 mg/d, prazosin 5 mg/d, and rilmenidine 1 mg/d and spironolactone 12.5 to 25 mg/d, will be sequentially added from months two to five in both groups if home blood pressure remains more than or equal to 135/85 mm Hg.
| Study group | Role | What they receive |
|---|---|---|
| Renal artery stenting | Experimental | Renal artery angioplasty plus stenting and standardized and optimized medication regimen.
Patients are treated with renal artery stenting plus a standardized optimal medical treatment, including the antihypertensive treatment which is adapted every month starting two month after randomization on the basis of home BP monitoring results at follow-up visits. Receives: Device: Renal artery Angioplasty plus stenting.; Drug: Anti hypertensive, statin and antiplatelet medication. |
| standardized and optimized medication regimen | Active comparator | Patients are treated with a standardized optimal medical treatment including the antihypertensive treatment which is adapted every month starting two month after randomization on the basis of home BP monitoring results at follow-up visits. Receives: Drug: Anti hypertensive, statin and antiplatelet medication. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in diurnal systolic blood pressure assessed by ambulatory BP monitoring (ABPM)
Measured: Baseline to 6 months
Secondary outcomes (11)
Adverse events of renal artery stenting
Measured: Baseline to 12 months
Change in average 24-hour and nighttime Systolic Blood Pressure by ABPM
Measured: Baseline to 12 months
Change in average 24-hour, daytime and nighttime diastolic Blood Pressure by ABPM
Measured: Baseline to 12 months
Change in Systolic/diastolic Blood Pressure by home blood pressure monitoring
Measured: Baseline to 12 months
Change in office Systolic/diastolic Blood Pressure
Measured: Baseline to 12 months
Antihypertensive medication score
Measured: Baseline to 12 months
Detection of the drugs in urine by LC-MS/MS
Measured: Baseline to 12 months
Renal artery restenosis in patients of the stenting group assessed by duplex ultrasound and/or renal CTA
Measured: Baseline to 12 months
Adverse cardiovascular (CV) events
Measured: Baseline to 12 months
Change in plasma creatinine and eGFR
Measured: Baseline to 12 months
Clinical renal events: renal death, progressive renal insufficiency (i.e. need for dialysis), need for permanent renal replacement therapy, need of target vessel stenting in the SOMT group (number of crossovers)
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2016
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Michel AZIZI, Principal investigator, HEGP - APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02539810
- Sponsor's protocol ID
- P140914
- Other IDs
- P140914
- Acronym
- ANDORRA
- Status last verified
- Jan 2018
- First submitted
- 28 Jul 2015
- Last updated
- 26 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02539810
- Acronym / sponsor ID
- ANDORRA / P140914
- Conditions
- Hypertension, Hypertension Resistant to Conventional Therapy, Angiographically Proven Grade III Unilateral or Bilateral Atherosclerotic Renal Artery Stenosis (ARAS) Greater Than or Equal to 60 Percent
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Sep 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 3 Sep 2015 (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 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%.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renal artery stenting | Experimental | Device: Renal artery Angioplasty plus stenting., Drug: Anti hypertensive, statin and antiplatelet medication.Renal artery angioplasty plus stenting and standardized and optimized medication regimen. Patients are treated with renal artery stenting plus a standardized optimal medical treatment, including the antihypertensive treatment which is adapted every month starting two month after randomization on the basis of home BP monitoring results at follow-up visits. |
| standardized and optimized medication regimen | Active comparator | Drug: Anti hypertensive, statin and antiplatelet medication.Patients are treated with a standardized optimal medical treatment including the antihypertensive treatment which is adapted every month starting two month after randomization on the basis of home BP monitoring results at follow-up visits. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age: 40 to 80 Years
- Men or women
- Supine office BP ≥ 140 and/or 90 mmHg at screening despite a stable medication regimen including full tolerated doses of 3 or more anti-hypertensive treatments of different classes, including a diuretic.
- Unilateral or bilateral ARAS of a main renal artery ≥60% diagnosed by renal CT- angiogram (or MR-angiogram if there is a contraindication to perform CT) performed in the year before
- One or two functional kidney(s) ≥ 70 mm in pole-to-pole length
Key exclusion criteria (24 listed)
- Fibromuscular dysplasia of renal artery or other non-atherosclerotic renal artery stenosis
- Other secondary form of hypertension excluded on the basis of a clinical, hormonological and/or imaging work-up
- Restenosis after a previous renal angioplasty or stenting
- Only a stenosis of an accessory renal artery supplying <1/2 of the ipsilateral renal parenchyma
- Additional indication of ARAS stenting (Malignant hypertension, ≥ 30% increase in plasma creatinine after renin angiotensin system (RAS) blocker or after RAS blocker and diuretic administration, flash pulmonary edema)
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 |
|---|---|---|
| Renal artery Angioplasty plus stenting.Also: RA Stentrenal artery stenting | Device | Renal artery stenting |
| Anti hypertensive, statin and antiplatelet medication.Also: SOMTSlow release indapamide 1.5 mg/d (or furosemide 40 mg/d if eGFR is < 30 mL/min/1.73m²) + irbesartan 300 mg/d + amlodipine 10 mg/d + aspirin 75 mg/d (or clopidogrel 75 mg/d in case of allergy or gastrointestinal intolerance to aspirin) + atorvastatin 20 mg/d. After randomization, bisoprolol 10 mg/d, prazosin 5 mg/d, and rilmenidine 1 mg/d and spironolactone 12.5 to 25 mg/d, will be sequentially added from months two to five in both groups if home blood pressure remains more than or equal to 135/85 mm Hg. | Drug | Renal artery stenting, standardized and optimized medication regimen |
Primary outcome
Mean change in diurnal systolic blood pressure assessed by ambulatory BP monitoring (ABPM)
Time frame: Baseline to 6 months
11 secondary outcomes
Adverse events of renal artery stenting
Time frame: Baseline to 12 months
Change in average 24-hour and nighttime Systolic Blood Pressure by ABPM
Time frame: Baseline to 12 months
Change in average 24-hour, daytime and nighttime diastolic Blood Pressure by ABPM
Time frame: Baseline to 12 months
Change in Systolic/diastolic Blood Pressure by home blood pressure monitoring
Time frame: Baseline to 12 months
Change in office Systolic/diastolic Blood Pressure
Time frame: Baseline to 12 months
Antihypertensive medication score
Time frame: Baseline to 12 months
Detection of the drugs in urine by LC-MS/MS
Time frame: Baseline to 12 months
Renal artery restenosis in patients of the stenting group assessed by duplex ultrasound and/or renal CTA
Time frame: Baseline to 12 months
Adverse cardiovascular (CV) events
Time frame: Baseline to 12 months
Change in plasma creatinine and eGFR
Time frame: Baseline to 12 months
Clinical renal events: renal death, progressive renal insufficiency (i.e. need for dialysis), need for permanent renal replacement therapy, need of target vessel stenting in the SOMT group (number of crossovers)
Time frame: Baseline to 12 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2018.
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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.
Michel AZIZI principal investigator
HEGP - APHP
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Renal artery Angioplasty plus stenting. and Anti hypertensive, statin and antiplatelet medication. in people with Hypertension and Hypertension Resistant to Conventional Therapy, run by Assistance Publique - Hôpitaux de Paris at 15 sites in France.
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 11 inclusion and 24 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 26 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France. 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. 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?
Mean change in diurnal systolic blood pressure assessed by ambulatory BP monitoring (ABPM) (time frame: Baseline to 6 months). 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 26 Jan 2018.