Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2025-12-26 @ 12:58 PM
Study NCT ID:
NCT02770066
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2016-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Danish National Registry of PTRA in Patients With Renovascular Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012078', 'term': 'Renal Artery Obstruction'}, {'id': 'D006978', 'term': 'Hypertension, Renovascular'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}], 'ancestors': [{'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': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D006977', 'term': 'Hypertension, Renal'}, {'id': 'D006973', 'term': 'Hypertension'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-01-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2035-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2016-05-09', 'studyFirstSubmitQcDate': '2016-05-10', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in 24-hour ambulatory systolic and diastolic blood pressures from baseline to 24 months after PTRA in patients with 24-hour ambulatory average systolic blood pressure ≥ 150 mmHg at baseline', 'timeFrame': 'Measured 24 months post-PTRA', 'description': 'Changes in 24-hour ambulatory systolic and diastolic blood pressures (calculated from hourly means) from baseline to 24 months after percutaneous transluminal renal angioplasty in patients with 24-hour ambulatory average systolic blood pressure ≥ 150 mmHg at baseline and with significant artery stenosis either\n\n1. Unilaterally (one or two kidneys)\n2. Bilaterally with treatment of both kidneys\n\nAll 24-hour ambulatory blood pressure measurements are performed after nurse-administered medication. Likewise, it will below be inferred that renal artery stenosis is defined as in the primary endpoint.'}], 'secondaryOutcomes': [{'measure': 'Changes in 24-hour ambulatory systolic and diastolic blood pressures from baseline to 24 months after PTRA in patients with 24-hour ambulatory average systolic blood pressure ≥ 130 mmHg at baseline', 'timeFrame': 'Measured 24 months post-PTRA', 'description': 'Changes in 24-hour ambulatory systolic and diastolic blood pressures (calculated from hourly means) from baseline to 24 months after percutaneous transluminal renal angioplasty in patients with 24-hour ambulatory average systolic blood pressure ≥ 130 mmHg at baseline and with significant artery stenosis'}, {'measure': 'Changes in 24-hour ambulatory systolic and diastolic blood pressures (statistically adjusted for treatment changes) from baseline to 24 months after PTRA in patients with 24-hour ambulatory average systolic blood pressure ≥ 150 mmHg at baseline', 'timeFrame': 'Measured 24 months post-PTRA', 'description': 'Changes in 24-hour ambulatory systolic and diastolic blood pressures (calculated from hourly means) (statistically adjusted for treatment changes) from baseline to 24 months after percutaneous transluminal renal angioplasty in patients with 24-hour ambulatory average systolic blood pressure ≥ 150 mmHg at baseline and with significant artery stenosis'}, {'measure': 'Changes in 24-hour ambulatory systolic and diastolic blood pressures (statistically adjusted for treatment changes) from baseline to 24 months after PTRA in patients with 24-hour ambulatory average systolic blood pressure ≥ 130 mmHg at baseline', 'timeFrame': 'Measured 24 months post-PTRA', 'description': 'Changes in 24-hour ambulatory systolic and diastolic blood pressures (calculated from hourly means) (statistically adjusted for treatment changes) from baseline to 24 months after percutaneous transluminal renal angioplasty in patients with 24-hour ambulatory average systolic blood pressure ≥ 130 mmHg at baseline and with significant artery stenosis'}, {'measure': 'Changes in 24-hour ambulatory systolic and diastolic blood pressures (unadjusted and statistically adjusted for treatment changes)', 'timeFrame': 'Measured at 3, 12, 36, 48 and 60 months', 'description': 'Changes in 24-hour ambulatory systolic and diastolic blood pressures (unadjusted and statistically adjusted for treatment changes) from baseline to 3, 12, 36, 48 and 60 months after PTRA in patients with 24-hour ambulatory average systolic blood pressure ≥ 150 mmHg and in patients with 24-hour ambulatory average systolic blood pressure ≥ 130 mmHg'}, {'measure': 'Change in antihypertensive treatment (defined daily doses)', 'timeFrame': 'Measured at 3, 12, 24, 36, 48 and 60 months'}, {'measure': 'Change in kidney function', 'timeFrame': 'Measured at 3, 12, 24, 36, 48 and 60 months', 'description': 'Change in estimated glomerular filtration rate (eGFR) and change in percentage side distribution measured by renography at baseline and 24 months after PTRA'}, {'measure': 'Clinical composite end point', 'timeFrame': 'Measured at 3, 12, 24, 36, 48 and 60 months', 'description': 'Clinical composite end point\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 30% or more in eGFR)\n7. permanent renal-replacement therapy\n\nOnly the first event per participant is included in the composite'}, {'measure': 'Safety composite end point (< 30 days after PTRA)', 'timeFrame': 'Measured at 3, 12, 24, 36, 48 and 60 months', 'description': 'Safety composite end point (\\< 30 days after PTRA)\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 30% or more in eGFR)\n6. ipsilateral nephrectomy\n7. pseudoaneurysm formation\n8. stent thrombosis\n\nOnly the first event per participant is included in the composite'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Renal Artery Obstruction', 'Hypertension, Renovascular', 'Cardiovascular Diseases', 'Kidney Diseases']}, 'referencesModule': {'references': [{'pmid': '35322677', 'type': 'DERIVED', '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': 'A prospective Danish national registry of percutaneous transluminal renal angioplasty (PTRA) in high-risk patients with renal artery stenosis selected on the basis of common national criteria, and with a common follow-up protocol for all three Danish centres offering PTRA'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'High-risk patients with renal artery stenosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Eligibility criteria\n\n1. True resistant hypertension (≥ 3 antihypertensive drugs including a diuretic, if tolerated, and each prescribed at optimal doses) and uncontrolled blood pressure confirmed by 24-hour ambulatory blood pressure monitoring. The 24-hour ambulatory blood pressure monitoring is performed after nurse-administered medication and blood pressure measurements are performed hourly. If the average 24-hour ambulatory systolic blood pressure is ≥ 130 mmHg the patient can be evaluated for renal artery stenosis.\n2. Hypertension and intolerance or side effects of the antihypertensive treatment. Hypertension is confirmed by 24-hour ambulatory blood pressure monitoring. The 24-hour ambulatory blood pressure monitoring is performed after nurse-administered medication and blood pressure measurements are performed hourly. If the average 24-hour ambulatory systolic blood pressure is ≥ 130 mmHg the patient can be evaluated for renal artery stenosis.\n3. Progressive renal insufficiency (a reduction in eGFR \\> 5 ml/min/1,73 m2 per year) in patients with bilateral renal artery stenosis or in patients with renal artery stenosis and only one kidney.\n4. Recurrent heart failure/pulmonary edema and resistant hypertension (≥ 3 antihypertensive drugs including a diuretic, if tolerated, and each prescribed at optimal doses) that may not be attributed to non-compliance, reduced left heart ventricular ejection fraction/heart valve disease or other obvious explanations (atrial fibrillation, fever, hyperthyroidism etc.). If the average 24-hour ambulatory systolic blood pressure is ≥ 130 mmHg after nurse-administered medication the patient can be evaluated for renal artery stenosis.\n5. Younger patients (\\< 40 years) with hypertension (24-hour ambulatory blood pressure monitoring ≥ 130/80 mmHg after nurse-administered medication )\n\nInclusion Criteria:\n\nAll of the following:\n\n1. At least one of the above eligibility criteria\n2. Duplex doppler ultrasonography or renography investigations consistent with hemodynamically significant renal artery stenosis\n3. CT angiography or renal arteriography with angiographic renal artery stenosis of ≥ 70 % reduction of the luminal diameter in at least one projection\n\nExclusion Criteria:\n\n1. If angiography/arteriography, ultrasonography or renography is consistent with bilateral significant renal artery stenosis and only one side is treated with PTRA\n2. PTRA of a renal artery supplying a kidney which pre-PTRA handles ≤ 10% of the total kidney function (with no blockage of the renin-angiotensin system) and has a kidney size \\< 7 cm (length)'}, 'identificationModule': {'nctId': 'NCT02770066', 'acronym': 'DAN-PTRA', 'briefTitle': 'A Prospective Danish National Registry of PTRA in Patients With Renovascular Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'A Prospective Danish National Registry of Percutaneous Transluminal Renal Angioplasty in Patients With Renovascular Hypertension', 'orgStudyIdInfo': {'id': 'DAN-PTRA'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Percutaneous transluminal renal angioplasty', 'type': 'DEVICE', 'description': 'Angioplasty plus stenting (angioplasty in patients with fibromuscular dysplasia)\n\nAdjuvant therapy in atherosclerotic renal artery stenosis - at the discretion of the treating physician\n\n* Antiplatelet therapy (usually standard)\n* Cholesterol-lowering drugs (usually standard)\n* Antihypertensive treatment with angiotensin-converting-enzyme inhibitor or angiotensin-receptor blocker (normally not contraindicated)\n* Smoking cessation, diet and physical activity (usually standard)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Aalborg', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Niels Henrik Buus, MD, DMSc', 'role': 'CONTACT', 'email': 'n.buus@rn.dk', 'phone': '+45 9766 3725'}, {'name': 'Niels Henrik Buus, MD, DMSc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Aalborg University Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'zip': '8200', 'city': 'Aarhus N', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Mark Reinhard, MD, PhD', 'role': 'CONTACT', 'email': 'm.reinhard@dadlnet.dk', 'phone': '+45 4046 0321'}, {'name': 'Kent L Christensen, MD, DMSc', 'role': 'CONTACT', 'email': 'klc@dadlnet.dk', 'phone': '+45 7845 2455'}, {'name': 'Mark Reinhard, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Kent L Christensen, MD, DMSc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.20367, 'lon': 10.17317}}, {'zip': '2600', 'city': 'Glostrup Municipality', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Ulrik B Andersen, MD', 'role': 'CONTACT', 'email': 'ulrik.bjoern.andersen@regionh.dk', 'phone': '+45 3863 3863'}, {'name': 'Jørgen Jeppesen, MD, DMSc', 'role': 'CONTACT', 'email': 'Joergen.Jeppesen.01@regionh.dk', 'phone': '+45 3863 3863'}, {'name': 'Ulrik B Andersen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jørgen Jeppesen, MD, DMSc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Glostrup University Hospital/ Rigshospitalet', 'geoPoint': {'lat': 55.6666, 'lon': 12.40377}}, {'zip': '4300', 'city': 'Holbæk', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Michael H Olsen, MD, DMSc', 'role': 'CONTACT', 'email': 'michael.olsen@dadlnet.dk'}, {'name': 'Michael H Olsen, MD, DMSc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Holbaek Hospital', 'geoPoint': {'lat': 55.7175, 'lon': 11.71279}}, {'zip': '5000', 'city': 'Odense C', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Karoline Schousboe, MD, PhD', 'role': 'CONTACT', 'email': 'Karoline.Schousboe@rsyd.dk', 'phone': '+45 5142 6110'}, {'name': 'Ib Abildgaard, MD, DMSc', 'role': 'CONTACT', 'email': 'Ib.Abildgaard@rsyd.dk', 'phone': '+45 6611 3333'}, {'name': 'Karoline Schousboe, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ib Abildgaard, MD, DMSc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.40841, 'lon': 10.39538}}], 'centralContacts': [{'name': 'Mark Reinhard, PhD', 'role': 'CONTACT', 'email': 'm.reinhard@dadlnet.dk', 'phone': '+45 7845 2455'}, {'name': 'Kent L Christensen, MD, DMSc', 'role': 'CONTACT', 'email': 'klc@dadlnet.dk', 'phone': '+45 7845 2455'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Mark Reinhard', 'investigatorAffiliation': 'University of Aarhus'}}}}