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
Even with optimal medical care, patients with renovascular disease have a very high risk of cardiovascular events and an expected poor outcome. One treatment option of atherosclerotic renal artery stenosis is percutaneous transluminal renal angioplasty with stent placement. Renal artery stenting is, however, still a subject of debate as randomized trials have failed to show a benefit of this compared with optimal medical treatment alone. Following the results of the large CORAL trial in 2014, we established the national prospective DAN-PTRA study using strict and well-defined criteria to select patients for renal artery stenting. In this study, we observed a reduction in blood pressure, an improved kidney function, and a decrease in new hospital admissions due to heart failure after renal artery stenting. The DAN-PTRAII study is a nationwide high-quality randomized, sham-controlled clinical trial in patients with severe renovascular disease due to atherosclerotic renal artery stenosis. Only patients who fulfill the inclusion criteria on optimal medical treatment can enter the study and only the operator and his team will know whether the patients receive renal artery stenting or sham treatment. Participants will be followed closely for 6 months after the treatment to evaluate the effects of renal artery stenting compared with optimal medical treatment alone on blood pressure, kidney function and hospitalizations due to heart failure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
80
* Optimal medical therapy, including maximally tolerated renin-angiotensin system blockade with either an angiotensin converting enzyme inhibitor or an angiotensin II receptor blocker * Diagnostic tests: Catheter-based angiography and measurement of translesional pressure gradients * Treatment: Renal artery stenting performed according to 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 * Diagnostic tests: Catheter-based angiography and measurement of translesional pressure gradients * Treatment: Sham
Aarhus University Hospital
Aarhus N, Denmark
RECRUITINGRigshospitalet
Copenhagen, Denmark
RECRUITINGOdense University Hospital
Odense C, Denmark
RECRUITINGChange in 24-hour ambulatory systolic blood pressure.
Change in 24-hour ambulatory systolic blood pressure from baseline to 6 months after renal artery stenting compared with optimal medical therapy alone.
Time frame: Baseline and 6 months.
Change in kidney function.
Change in kidney function (estimated glomerular filtration rate) from baseline to 6 months after renal artery stenting compared with optimal medical treatment alone.
Time frame: Baseline, Day 1, Day 7, Day 21, 6 weeks, 3 months, and 6 months.
Changes in antihypertensive treatment.
Changes in antihypertensive treatment (both defined daily dose \[DDD\] and number of agents) from baseline to 6 months after renal artery stenting compared with optimal medical treatment alone.
Time frame: Baseline, 3 months, and 6 months.
Change in 24-hour ambulatory systolic blood pressure (statistically adjusted for treatment changes).
Change in 24-hour ambulatory systolic blood pressure from baseline to 6 months after renal artery stenting compared with optimal medical therapy alone, with systolic blood pressure values adjusted for changes in the defined daily doses (DDD) of antihypertensive medications. A change of 1 DDD corresponds to a 5 mmHg change in systolic blood pressure.
Time frame: Baseline, 3 months, and 6 months.
Number of participants with cardiovascular and kidney outcomes.
Clinical events from baseline to 6 months after renal artery stenting compared with optimal medical treatment alone. Clinical events are defined using the same criteria as in the Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL) study except for progressive renal insufficiency (in the CORAL study defined as a reduction from baseline of 30% or more in the estimated GFR). Clinical events included in the composite endpoint from baseline to 6-month follow-up: 1. Death from cardiovascular causes 2. Death from renal causes 3. Stroke 4. Myocardial infarction 5. Hospitalization for congestive heart failure 6. Progressive renal insufficiency (a reduction from baseline of 50% or more in estimated GFR) 7. Permanent renal-replacement therapy Only the first event per participant is included in the composite.
Time frame: From baseline to 6 months after PTRA/sham.
Number of deaths from any cause.
Death from any cause from baseline to 6 months after renal artery stenting compared with optimal medical treatment alone.
Time frame: From baseline to 6 months after PTRA/sham.
Health status on 12-Item Short Form Survey (SF-12).
Changes in 12-item short form health survey (SF-12) from baseline to 6 months after renal artery stenting compared with optimal medical treatment alone. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
Time frame: Baseline, 3 months, and 6 months.
Number of serious adverse events (SAEs), procedure-related complications, and postoperative complications.
All serious adverse events, procedure-related complications (≤ 24 hours), and postoperative complications (\> 24 hours) occurring within 30 days after the procedure will be systematically recorded, including: 1. Death from any cause 2. Rupture, dissection, occlusion, or perforation of the renal artery 3. Stent thrombosis of the PTRA-treated renal artery 4. Embolic complications affecting the kidney or peripheral circulation (upper or lower extremity depending on access site) 5. Bleeding requiring transfusion 6. Embolization or nephrectomy due to bleeding or other complications 7. Access-related complications requiring treatment: bleeding, thrombosis, or pseudoaneurysm 8. Need for acute dialysis 9. Clinical events as defined in item 5
Time frame: From baseline to 30 days after PTRA/sham.
Evaluation of Diagnostic Techniques.
As part of the study, the applicability of diagnostic techniques that remain insufficiently described in the context of renal artery stenosis will be evaluated separately according to the protocol. The following examinations will be assessed: (a) Doppler ultrasound, (b) echocardiography, (c) renography, (d) invasive pressure measurements across stenoses, (e) computational fluid dynamics (CFD) simulations, and (f) proteomics analysis.
Time frame: From baseline to 6 months after PTRA/sham.
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