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Effekter af perkutan transluminal nyreangioplastik af aterosklerotisk nyrearteriestenose hos højrisikopatienter. (DAN-PTRAII)

9. november 2026 opdateret af: University of Aarhus

Effekter af perkutan transluminal nyreangioplastik af aterosklerotisk nyrearteriestenose hos højrisikopatienter - en dansk landsdækkende randomiseret sham-kontrolleret undersøgelse.

The goal of this clinical trial is to investigate whether percutaneous transluminal renal angioplasty (PTRA) with stent placement of atherosclerotic renal artery stenosis is beneficial in high-risk patients selected according to the criteria used in the DAN-PTRAI study. The main questions the trial aims to answer are whether renal artery stenting in addition to optimal medical therapy, compared with a sham procedure and optimal medical therapy, has beneficial effects on:

  • Blood pressure (primary outcome: 24-hour ambulatory systolic blood pressure at 6 months)
  • Kidney function
  • Hospitalizations for heart failure

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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-PTRAI 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 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 the interventional 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 a sham procedure, both in addition to optimal medical therapy, on blood pressure, kidney function, and hospitalizations for heart failure.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

80

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Sebastian Nielsen, MD
  • Telefonnummer: +45 23100484
  • E-mail: sebane@rm.dk

Undersøgelse Kontakt Backup

  • Navn: Mark Reinhard, MD, PhD
  • Telefonnummer: +45 40460321
  • E-mail: markrein@rm.dk

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. One or more severe atherosclerotic renal artery stenoses defined as a stenosis ≥70% by catheter-based angiography.

  2. In addition, at least one of the following high-risk clinical syndromes:

    1. 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.
    2. 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.
    3. Hospital admissions with acute decompensated heart failure (≥2 hospitalizations for heart failure or ≥1 hospitalization 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 measurements are performed after nurse-administered medication.

Exclusion Criteria:

  • 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 with stent placement.
  • Presence of a renal artery stenosis not amenable for treatment with a stent.
  • Intolerance to any antithrombotic treatment.

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:

  1. Treatment-resistant heart failure episodes presumed caused by renovascular disease.

  2. Rapidly declining kidney function/acute kidney failure approaching the need for dialysis presumed caused by renovascular disease.

  3. 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 mmHg, or
    • a systolic translesional gradient of ≥20 mmHg, or
    • a renal fractional flow reserve (Pd/Pa) of ≤0.80

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Renal artery stenting

Percutaneous transluminal renal angioplasty with stent placement
Diagnostisk test: Catheter-based angiography

Catheter-based angiography performed in accordance with the study protocol.

Diagnostisk test: Measurement of translesional pressure gradients

Measurement of translesional pressure gradients performed in accordance with the study protocol.

Medicin: Optimal medical therapy (OMT)

Optimal medical therapy, including maximally tolerated renin-angiotensin system blockade with either an angiotensin-converting enzyme inhibitor or an angiotensin II receptor blocker.

Procedure: Renal artery stenting

Renal artery stenting performed in accordance with the study protocol.
Sham-komparator: Sham procedure

Sham procedure
Diagnostisk test: Catheter-based angiography

Catheter-based angiography performed in accordance with the study protocol.

Diagnostisk test: Measurement of translesional pressure gradients

Measurement of translesional pressure gradients performed in accordance with the study protocol.

Medicin: Optimal medical therapy (OMT)

Optimal medical therapy, including maximally tolerated renin-angiotensin system blockade with either an angiotensin-converting enzyme inhibitor or an angiotensin II receptor blocker.

Procedure: Sham (No Treatment)

Sham procedure performed in accordance with the study protocol.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in 24-hour ambulatory systolic blood pressure
Tidsramme: Baseline and 6 months

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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in estimated glomerular filtration rate (eGFR)
Tidsramme: Baseline, Day 1, Day 7, Day 21, 6 weeks, 3 months, 4.5 months, and 6 months

Defined as the between-group difference in the change in estimated glomerular filtration rate (eGFR) from baseline to 6 months.
Baseline, Day 1, Day 7, Day 21, 6 weeks, 3 months, 4.5 months, and 6 months
Change in urine albumin-to-creatinine ratio (UACR)
Tidsramme: Baseline, 3 months, and 6 months

Defined as the between-group difference in the change in urine albumin-to-creatinine ratio from baseline to 3 and 6 months.
Baseline, 3 months, and 6 months
Change in attended automated office systolic blood pressure
Tidsramme: Baseline, 3 months, and 6 months

Defined as the between-group difference in the change in attended automated office systolic blood pressure from baseline to 3 and 6 months.
Baseline, 3 months, and 6 months
Change in unattended automated office systolic blood pressure
Tidsramme: Baseline, 3 months, and 6 months

Defined as the between-group difference in the change in unattended automated office systolic blood pressure from baseline to 3 and 6 months.
Baseline, 3 months, and 6 months
Change in defined daily dose (DDD) of antihypertensive medications
Tidsramme: Baseline, 3 months, and 6 months

Defined as the between-group difference in the change in defined daily dose (DDD) of antihypertensive medications from baseline to 3 and 6 months.
Baseline, 3 months, and 6 months
Change in the number of antihypertensive medications
Tidsramme: Baseline, 3 months, and 6 months

Defined as the between-group difference in the change in the number of antihypertensive medications from baseline to 3 and 6 months.
Baseline, 3 months, and 6 months
Change in 24-hour ambulatory systolic blood pressure (corrected for changes in antihypertensive medication)
Tidsramme: Baseline, 3 months, and 6 months

Defined as the between-group difference in the change in 24-hour ambulatory systolic blood pressure from baseline to 3 and 6 months, corrected for changes in antihypertensive medication burden (1 DDD = 5 mmHg).
Baseline, 3 months, and 6 months
Number of participants with cardiovascular or kidney outcomes
Tidsramme: From baseline to 6 months

Between-group comparison of the number of participants with clinical events from baseline to 6 months.

Clinical events are defined using the same criteria as in the Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL) trial, except for progressive renal insufficiency (defined in CORAL as a reduction from baseline of 30% or more in estimated GFR).

Clinical events included in the composite endpoint from baseline to 6-month follow-up are:

  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.
From baseline to 6 months
Number of deaths from any cause
Tidsramme: From baseline to 6 months

Between-group comparison of the number of participants with death from any cause from baseline to 6 months.
From baseline to 6 months
Change in health status on 12-item Short Form Health Survey (SF-12)
Tidsramme: Baseline, 3 months, and 6 months

Defined as the between-group difference in the change in 12-item Short Form Health Survey (SF-12) scores from baseline to 3 and 6 months.

Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
Baseline, 3 months, and 6 months
Change in intrarenal resistive index
Tidsramme: Baseline and 6 months

Defined as the between-group difference in the change in intrarenal resistive index (unitless) of the affected kidney from baseline to 6 months, measured by Doppler ultrasound.

Additional renal ultrasound and Doppler parameters (kidney length, peak systolic velocity, acceleration time, renal-renal ratio, and pulsatility index) will be assessed at baseline and 6 months and compared between groups. In exploratory analyses, the association between baseline intrarenal resistive index (≥0.80 vs <0.80) and the change in 24-hour ambulatory systolic blood pressure and eGFR from baseline to 6 months will be evaluated, and the diagnostic accuracy (sensitivity and specificity) of baseline Doppler ultrasound for identifying hemodynamically significant renal artery stenosis will be assessed using invasive pressure measurement as the reference standard.
Baseline and 6 months
Change in left ventricular mass index
Tidsramme: Baseline and 6 months

Defined as the between-group difference in the change in left ventricular mass index (g/m²) from baseline to 6 months, assessed by transthoracic echocardiography.

Additional transthoracic echocardiographic parameters of cardiac systolic and diastolic function and cardiac chamber dimensions and volumes will be assessed at baseline and 6 months and compared between groups.
Baseline and 6 months
Translesional pressure ratio (Pd/Pa) across renal artery stenoses
Tidsramme: Baseline and 6 months

Defined as the distal-to-aortic pressure ratio (Pd/Pa, unitless) across the target renal artery stenosis, measured by intra-arterial pressure assessment during the endovascular procedure.

Systolic, diastolic, mean, and pulse pressure gradients (mmHg) across the target renal artery stenosis will be measured invasively during the procedure. In exploratory analyses, the association between baseline Pd/Pa and mean and systolic translesional pressure gradients and the change in 24-hour ambulatory systolic blood pressure and eGFR from baseline to 6 months will be evaluated, and whether the effect of PTRA differs according to baseline Pd/Pa will be explored.
Baseline and 6 months
Agreement between CFD-derived and invasively measured translesional pressure ratio (Pd/Pa)
Tidsramme: Baseline and 6 months

Defined as the mean difference (Bland-Altman bias, unitless) between Pd/Pa derived non-invasively from CT angiography using computational fluid dynamics (CFD) and Pd/Pa measured invasively during the endovascular procedure.

Agreement between CFD-derived and invasively measured mean and systolic translesional pressure gradients will be assessed correspondingly. In exploratory analyses, the association between CFD-derived Pd/Pa and mean and systolic translesional pressure gradients and the change in 24-hour ambulatory systolic blood pressure and eGFR from baseline to 6 months will be evaluated.
Baseline and 6 months
Change in plasma renin
Tidsramme: Baseline, 3 months, and 6 months

Defined as the between-group difference in the change in plasma renin concentration (mIU/L) from baseline to 3 and 6 months.

In exploratory analyses, the association between baseline plasma renin and the change in 24-hour ambulatory systolic blood pressure and eGFR from baseline to 6 months will be evaluated.
Baseline, 3 months, and 6 months
Change in plasma aldosterone
Tidsramme: Baseline, 3 months, and 6 months

Defined as the between-group difference in the change in plasma aldosterone concentration (pmol/L) from baseline to 3 and 6 months.

In exploratory analyses, the association between baseline plasma aldosterone and the change in 24-hour ambulatory systolic blood pressure and eGFR from baseline to 6 months will be evaluated.
Baseline, 3 months, and 6 months
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP)
Tidsramme: Baseline, 3 months, and 6 months

Defined as the between-group difference in the change in plasma NT-proBNP concentration (ng/L) from baseline to 3 and 6 months.

In exploratory analyses, the association between changes in echocardiographic parameters, including left ventricular mass index, and the change in NT-proBNP from baseline to 6 months will be evaluated to assess whether changes in NT-proBNP reflect changes in cardiac structure and function.
Baseline, 3 months, and 6 months
Proteomic profile in blood and on the angioplasty balloon
Tidsramme: Baseline and 6 months

Defined as the proteomic profile in blood and in material retrieved from the angioplasty balloon after dilation during PTRA. In exploratory analyses, the association between the proteomic profile and the change in 24-hour ambulatory systolic blood pressure and eGFR from baseline to 6 months, and the need for reintervention due to restenosis, will be evaluated. Proteomic analyses will be described in a separate analysis plan.
Baseline and 6 months
Number of serious adverse events (SAEs) during follow-up and procedure-related and postoperative adverse events within 30 days after the procedure
Tidsramme: From baseline to 6 months (SAEs); from baseline to 30 days (procedure-related and postoperative adverse events)

All SAEs occurring from baseline to 6 months, as well as procedure-related adverse events (≤24 hours) and postoperative adverse events (>24 hours) occurring within 30 days after the procedure, will be systematically recorded and compared between groups as the proportion of participants with at least one event. Events include, but are not limited to:

  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 above
From baseline to 6 months (SAEs); from baseline to 30 days (procedure-related and postoperative adverse events)
Change in split renal function of the affected kidney
Tidsramme: Baseline and 6 months

Defined as the between-group difference in the change in split renal function (%) of the affected kidney from baseline to 6 months, assessed by renography.

The change in renogram configuration (renogram grade) of the affected kidney from baseline to 6 months will be compared between groups as the proportion of participants with improvement in renogram grade. In exploratory analyses, the diagnostic accuracy (sensitivity and specificity) of baseline renography for identifying hemodynamically significant renal artery stenosis will be assessed using invasive pressure measurement as the reference standard, and the association between baseline renography with intermediate/high probability of renal artery stenosis and the change in 24-hour ambulatory systolic blood pressure and eGFR from baseline to 6 months will be evaluated.
Baseline and 6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Aarhus

Samarbejdspartnere

Odense University Hospital
Aarhus University Hospital
Aalborg University Hospital
Holbaek Sygehus
Gødstrup Hospital
The Augustinus Foundation, Denmark.
Amsterdam UMC
Novo Nordisk Foundation
Copenhagen University Hospital, Rigshospitalet

Efterforskere

  • Ledende efterforsker: Mark Reinhard, MD, PhD, Aarhus University Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

26. juni 2023

Primær færdiggørelse (Anslået)

1. juni 2027

Studieafslutning (Anslået)

1. juni 2027

Datoer for studieregistrering

Først indsendt

3. april 2023

Først indsendt, der opfyldte QC-kriterier

17. april 2023

Først opslået (Faktiske)

28. april 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • DAN-PTRAII

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