Effects of Percutaneous Transluminal Renal Angioplasty of Atherosclerotic Renal Artery Stenosis in High-Risk Patients.
DAN-PTRAII
1 other identifier
interventional
80
1 country
3
Brief Summary
The goal of this clinical trial is to document a beneficial effect of percutaneous transluminal renal angioplasty (PTRA) of atherosclerotic renal artery stenosis in high-risk patients selected according to the criteria used in the DAN-PTRA study. The main questions the trial aims to answer are if renal artery stenting compared with optimal medical treatment alone has beneficial effects on:
- Blood pressure
- Kidney function
- Hospitalizations for heart failure
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2023
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 3, 2023
CompletedFirst Posted
Study publicly available on registry
April 28, 2023
CompletedStudy Start
First participant enrolled
June 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
April 23, 2026
March 1, 2026
3.9 years
April 3, 2023
April 20, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change in 24-hour ambulatory systolic blood pressure
Defined as the between-group difference in the change in 24-hour ambulatory systolic blood pressure from baseline to 6 months.
Baseline and 6 months
Secondary Outcomes (11)
Change in estimated glomerular filtration rate (eGFR)
Baseline, Day 1, Day 7, Day 21, 6 weeks, 3 months, 4.5 months, and 6 months
Change in attended automated office systolic blood pressure
Baseline, 3 months, and 6 months
Change in unattended automated office systolic blood pressure
Baseline, 3 months, and 6 months
Change in defined daily dose (DDD) of antihypertensive medications
Baseline, 3 months, and 6 months
Change in the number of antihypertensive medications
Baseline, 3 months, and 6 months
- +6 more secondary outcomes
Study Arms (2)
Renal artery stenting
ACTIVE COMPARATORPercutaneous transluminal renal angioplasty with stent placement
Sham procedure
SHAM COMPARATORSham procedure
Interventions
Renal artery stenting performed in accordance with the study protocol.
Optimal medical therapy, including maximally tolerated renin-angiotensin system blockade with either an angiotensin-converting enzyme inhibitor or an angiotensin II receptor blocker.
Catheter-based angiography performed in accordance with the study protocol.
Measurement of translesional pressure gradients performed in accordance with the study protocol.
Sham procedure performed in accordance with the study protocol.
Eligibility Criteria
You may qualify if:
- One or more severe atherosclerotic renal artery stenoses defined as a stenosis ≥70% by catheter-based angiography.
- In addition, at least one of the following high-risk clinical syndromes:
- Resistant hypertension with average 24-hour ambulatory systolic blood pressure ≥150 mmHg despite ≥3 antihypertensive drugs including a diuretic, if tolerated, and each prescribed at optimal doses.
- Rapidly declining kidney function with a reduction in estimated GFR of \>5 mL/min per 1.73m2 per year and average 24-hour ambulatory systolic blood pressure ≥140 mmHg despite ≥3 antihypertensive drugs including a diuretic, if tolerated, and each prescribed at optimal doses.
- Hospital admissions with acute decompensated heart failure (≥2 hospitalizations for heart failure or ≥1 hospitalizations for sudden, "flash" pulmonary edema) with no obvious explanations such as nonadherence, left ventricular ejection fraction \<40%, or valvular heart disease and average 24-hour ambulatory systolic blood pressure ≥140 mmHg despite ≥3 antihypertensive drugs including a diuretic, if tolerated, and each prescribed at optimal doses.
- All 24-hour ambulatory blood pressure monitorings are performed after nurse-administered medication.
You may not qualify if:
- Unable to provide informed consent.
- Treatment-resistant heart failure episodes presumed caused by renovascular disease.
- Rapidly declining kidney function/acute kidney failure approaching the need for dialysis presumed caused by renovascular disease.
- Fibromuscular dysplasia or other non-atherosclerotic renal artery stenosis known to be present prior to randomization.
- Pregnancy or unknown pregnancy status in female of childbearing potential.
- Kidney size \<7 cm (pole to pole length) supplied by target vessel.
- Previous kidney transplant.
- Previous PTRA treatment.
- Presence of a renal artery stenosis not amenable for treatment with a stent.
- Patients who are not eligible for randomization but treated with renal artery stenting outside the protocol are followed according to the DAN-PTRAII protocol in order to account for all PTRA treatments performed in Denmark in the study period.
- Patients treated with renal artery stenting without randomization in the study period include patients with:
- Treatment-resistant heart failure episodes presumed caused by renovascular disease.
- Rapidly declining kidney function/acute kidney failure approaching the need for dialysis presumed caused by renovascular disease.
- At least one of the listed high-risk clinical syndromes AND one or more significant atherosclerotic renal artery stenoses defined as a stenosis of 50-69% by catheter-based angiography with:
- a mean translesional gradient of ≥10 mm Hg, or
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- Aarhus University Hospitalcollaborator
- Aalborg University Hospitalcollaborator
- Gødstrup Hospitalcollaborator
- Holbaek Sygehuscollaborator
- Rigshospitalet, Denmarkcollaborator
- Odense University Hospitalcollaborator
- Amsterdam UMCcollaborator
- The Novo Nordic Foundationcollaborator
- The Augustinus Foundation, Denmark.collaborator
Study Sites (3)
Aarhus University Hospital
Aarhus N, 8200, Denmark
Rigshospitalet
Copenhagen, 2100, Denmark
Odense University Hospital
Odense C, 5000, Denmark
Related Publications (1)
Reinhard M, Schousboe K, Andersen UB, Buus NH, Rantanen JM, Bech JN, Mafi HM, Langfeldt S, Bharadwaz A, Horlyck A, Jensen MK, Jeppesen J, Olsen MH, Jacobsen IA, Bibby BM, Christensen KL. Renal Artery Stenting in Consecutive High-Risk Patients With Atherosclerotic Renovascular Disease: A Prospective 2-Center Cohort Study. J Am Heart Assoc. 2022 Apr 5;11(7):e024421. doi: 10.1161/JAHA.121.024421. Epub 2022 Mar 24.
PMID: 35322677RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Reinhard, MD, PhD
Aarhus University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Only the operator and his team will know whether the patient receives active treatment or sham treatment. The patient will wear a sleep mask and earplugs during the procedure to ensure blinding. Pressure gradient measurements will be performed in both groups.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2023
First Posted
April 28, 2023
Study Start
June 26, 2023
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
April 23, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share