Renal Artery Stenting in Patients With Documented Resistant Hypertension and Atherosclerotic Renal Artery Stenosis (ANDORRA)

NCT02539810 | Terminated Phase 4

• 1 other identifier: P140914
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 15

Brief 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) and angiographically proven grade III unilateral or bilateral atherosclerotic renal artery stenosis (ARAS) ≥ 60%.

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

Outcome Measures

Primary Outcomes (1)

• Mean change in diurnal systolic blood pressure assessed by ambulatory BP monitoring (ABPM)

  Baseline to 6 months

Secondary Outcomes (11)

• Adverse events of renal artery stenting

  Baseline to 12 months

• Change in average 24-hour and nighttime Systolic Blood Pressure by ABPM

  Baseline to 12 months

• Change in average 24-hour, daytime and nighttime diastolic Blood Pressure by ABPM

  Baseline to 12 months

• Change in Systolic/diastolic Blood Pressure by home blood pressure monitoring

  Baseline to 12 months

• Change in office Systolic/diastolic Blood Pressure

  Baseline to 12 months

Study Arms (2)

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.

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.

Drug: Anti hypertensive, statin and antiplatelet medication.

Interventions

Renal artery Angioplasty plus stenting. DEVICE

renal artery stenting

Also known as: RA Stent

Renal artery stenting

Anti hypertensive, statin and antiplatelet medication. DRUG

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.

Also known as: SOMT

Renal artery stenting; standardized and optimized medication regimen

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Ministry of Health, France: collaborator

Study Sites (15)

Hopital Pasteur

Nice, Alpes-Maritimes, 06002, France

Location

Hopital Saint Andre - CHU Bordeaux

Bordeaux, Gironde, 33075, France

Location

Hopital Rangueil - CHU Toulouse

Toulouse, Haute-Garonne, 31059, France

Location

Hopital Lapeyronie - CHU Montpellier

Montpellier, Herault, 34295, France

Location

Hopital Arthur Gardiner

Dinard, Ille-et-Vilaine, 35800, France

Location

Hopital Pontchaillou - CHU Rennes

Rennes, Ille-et-Vilaine, 35033, France

Location

Groupe Hospitalier Mutualiste

Grenoble, Isere, 38028, France

Location

Hopital Michallon - CHU Grenoble

La Tronche, Isere, 38700, France

Location

Institut Lorrain du Cœur et des Vaisseaux Louis Mathieu

Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54500, France

Location

Hopital de Brabois

Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54511, France

Location

Hopital Cardiologique - CHRU Lille

Lille, Nord, 59037, France

Location

CHU Clermont-Ferrand

Clermont-Ferrand, Puy-de-Dome, 63000, France

Location

Hopital de la Croix-Rousse - CHU Lyon

Lyon, Rhone, 69004, France

Location

Hopital de la Pitie Salpetriere

Paris, 75013, France

Location

Hopital Europeen Georges Pompidou (HEGP)

Paris, 75015, France

Location

MeSH Terms

Conditions

Hypertension; Hypertension Resistant to Conventional Therapy

Interventions

Stents; Antihypertensive Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies; Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Lipid Regulating Agents

Study Officials

• Michel AZIZI

  HEGP - APHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2015
• First Posted: September 3, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: July 1, 2017
• Last Updated: January 26, 2018

Record last verified: 2018-01

Locations

FR (15)