Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-25 @ 4:47 PM
Study NCT ID:
NCT05834803
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2023-04-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Percutaneous Transluminal Renal Angioplasty of Atherosclerotic Renal Artery Stenosis in High-Risk Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006978', 'term': 'Hypertension, Renovascular'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006977', 'term': 'Hypertension, Renal'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A Danish Nationwide (3-center) Randomized and Sham-Controlled Study.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-08', 'studyFirstSubmitDate': '2023-04-03', 'studyFirstSubmitQcDate': '2023-04-17', 'lastUpdatePostDateStruct': {'date': '2024-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in 24-hour ambulatory systolic blood pressure.', 'timeFrame': '6 months after PTRA/sham', 'description': 'Changes in 24-hour ambulatory systolic blood pressure from baseline to 6 months after renal artery stenting compared with optimal medical treatment alone in patients with 24-hour ambulatory average systolic blood pressure ≥150 mmHg at baseline.'}], 'secondaryOutcomes': [{'measure': 'Changes in kidney function.', 'timeFrame': '6 months after PTRA/sham', 'description': 'Changes in kidney function (estimated glomerular filtration rate) from baseline to 6 months after renal artery stenting compared with optimal medical treatment alone.'}, {'measure': 'Changes in antihypertensive treatment (defined daily doses).', 'timeFrame': '6 months after PTRA/sham', 'description': 'Changes in antihypertensive treatment (defined daily doses) from baseline to 6 months after renal artery stenting compared with optimal medical treatment alone.'}, {'measure': 'Changes in 24-hour ambulatory systolic blood pressure (statistically adjusted for treatment changes).', 'timeFrame': '6 months after PTRA/sham', 'description': 'Changes in 24-hour ambulatory systolic blood pressure from baseline to 6 months after renal artery stenting compared with optimal medical treatment alone in patients with 24-hour ambulatory average systolic blood pressure ≥150 mmHg at baseline. Changes in systolic blood pressure will be adjusted for changes in the defined daily doses (DDD) of antihypertensive medications, where a change of 1DDD equals a change of 5 mmHg in the systolic blood pressure.'}, {'measure': 'Number of participants with cardiovascular and kidney outcomes.', 'timeFrame': '6 months after PTRA/sham', 'description': 'Clinical events included in the composite end point from baseline to 6-month follow-up:\n\n1. death from cardiovascular causes\n2. death from renal causes\n3. stroke\n4. myocardial infarction\n5. hospitalization for congestive heart failure\n6. progressive renal insufficiency (a reduction from baseline of 50% or more in estimated GFR)\n7. permanent renal-replacement therapy\n\nClinical 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).\n\nOnly the first event per participant is included in the composite.'}, {'measure': 'Number of deaths from any cause.', 'timeFrame': '6 months after PTRA/sham', 'description': 'Death from any cause from baseline to 6 months after renal artery stenting compared with optimal medical treatment alone.'}, {'measure': 'Health status on 12-Item Short Form Survey (SF-12).', 'timeFrame': '6 months after PTRA/sham', 'description': '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.\n\nScores range from 0 to 100, with higher scores indicating better physical and mental health functioning.'}, {'measure': 'Number of participants with procedure-related major adverse events (MAE) <30 days of PTRA/sham.', 'timeFrame': '<30 days after PTRA/sham', 'description': 'Number of participants with procedure-related MAEs including:\n\n1. all cause mortality\n2. rupture, dissection, perforation or occlusion of renal artery\n3. critical bleeding (need of blood transfusion)\n4. embolization\n5. significant loss of kidney function (reduction from baseline of 50% or more in eGFR)\n6. permanent renal-replacement therapy\n7. ipsilateral nephrectomy\n8. access complications requiring treatment: bleeding, pseudoaneurysm or thrombosis\n9. stent thrombosis after renal artery stenting'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Renovascular Hypertension', 'Renovascular Hypertension With Renal Failure', 'Heart Failure', 'Renal Artery Stenosis Atherosclerotic', 'Percutaneous Transluminal Angioplasty']}, 'referencesModule': {'references': [{'pmid': '35322677', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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:\n\n* Blood pressure\n* Kidney function\n* Hospitalizations for heart failure', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. One or more severe atherosclerotic renal artery stenoses defined as a stenosis ≥70% by catheter-based angiography.\n2. In addition, at least one of the following high-risk clinical syndromes:\n\n 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.\n 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.\n 3. 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.\n\nAll 24-hour ambulatory blood pressure monitorings are performed after nurse-administered medication.\n\nExclusion Criteria:\n\n* Unable to provide informed consent.\n* Treatment resistant heart failure episodes presumed caused by renovascular disease.\n* Rapidly declining kidney function/acute kidney failure approaching the need for dialysis presumed caused by renovascular disease.\n* Fibromuscular dysplasia or other non-atherosclerotic renal artery stenosis known to be present prior to randomization.\n* Pregnancy or unknown pregnancy status in female of childbearing potential.\n* Kidney size \\<7 cm (pole to pole length) supplied by target vessel.\n* Previous kidney transplant.\n* Previous PTRA treatment.\n* Presence of a renal artery stenosis not amenable for treatment with a stent.\n\nPatients 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.\n\nPatients treated with renal artery stenting without randomization in the study period include patients with:\n\n1. Treatment resistant heart failure episodes presumed caused by renovascular disease.\n2. Rapidly declining kidney function/acute kidney failure approaching the need for dialysis presumed caused by renovascular disease.\n3. 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:\n\n * a mean translesional gradient of ≥10 mm Hg, or\n * a systolic translesional gradient of ≥20 mm Hg, or\n * a renal fractional flow reserve (Pd/Pa) of ≤0.8'}, 'identificationModule': {'nctId': 'NCT05834803', 'acronym': 'DAN-PTRAII', 'briefTitle': 'Effects of Percutaneous Transluminal Renal Angioplasty of Atherosclerotic Renal Artery Stenosis in High-Risk Patients.', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Effects of Percutaneous Transluminal Renal Angioplasty of Atherosclerotic Renal Artery Stenosis in High-Risk Patients - a Danish Nationwide Randomized Sham-Controlled Study.', 'orgStudyIdInfo': {'id': 'DAN-PTRAII'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Renal artery stenting', 'description': 'Percutaneous transluminal renal angioplasty with stent placement.', 'interventionNames': ['Procedure: Renal artery stenting']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham treatment', 'description': 'Sham treatment.', 'interventionNames': ['Procedure: Sham treatment']}], 'interventions': [{'name': 'Renal artery stenting', 'type': 'PROCEDURE', 'description': 'Optimal medical therapy and percutaneous transluminal renal angioplasty with stent placement.', 'armGroupLabels': ['Renal artery stenting']}, {'name': 'Sham treatment', 'type': 'PROCEDURE', 'description': 'Optimal medical therapy and sham treatment.', 'armGroupLabels': ['Sham treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus N', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Sebastian Nielsen, MD', 'role': 'CONTACT', 'email': 'sebane@rm.dk'}], 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.20367, 'lon': 10.17317}}, {'zip': '2100', 'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Jonas P Eiberg, MD, PhD', 'role': 'CONTACT', 'email': 'jonas.peter.eiberg@regionh.dk'}], 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '5000', 'city': 'Odense C', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Steen Bonnema, MD, DMSc', 'role': 'CONTACT', 'email': 'steen.bonnema@rsyd.dk'}], 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.40841, 'lon': 10.39538}}], 'centralContacts': [{'name': 'Sebastian Nielsen, MD', 'role': 'CONTACT', 'email': 'sebane@rm.dk', 'phone': '+45 40460321'}, {'name': 'Mark Reinhard, MD, PhD', 'role': 'CONTACT', 'email': 'm.reinhard@dadlnet.dk', 'phone': '+45 40460321'}], 'overallOfficials': [{'name': 'Mark Reinhard, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aarhus University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aarhus University Hospital', 'class': 'OTHER'}, {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, {'name': 'Odense University Hospital', 'class': 'OTHER'}, {'name': 'Amsterdam UMC', 'class': 'OTHER'}, {'name': 'The Novo Nordic Foundation', 'class': 'OTHER'}, {'name': 'The Augustinus Foundation, Denmark.', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}