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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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous transluminal renal angioplasty | Device | Angioplasty plus stenting (angioplasty in patients with fibromuscular dysplasia) Adjuvant therapy in atherosclerotic renal artery stenosis - at the discretion of the treating physician
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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
All 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. | Measured 24 months post-PTRA |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Eligibility criteria
Inclusion Criteria:
All of the following:
Exclusion Criteria:
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High-risk patients with renal artery stenosis
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mark Reinhard, PhD | Contact | +45 7845 2455 | m.reinhard@dadlnet.dk | |
| Kent L Christensen, MD, DMSc | Contact | +45 7845 2455 | klc@dadlnet.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University Hospital | Recruiting | Aalborg | 9000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35322677 | Derived | 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. |
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| Measured 24 months post-PTRA |
| 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 | 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 | Measured 24 months post-PTRA |
| 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 | 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 | Measured 24 months post-PTRA |
| Changes in 24-hour ambulatory systolic and diastolic blood pressures (unadjusted and statistically adjusted for treatment changes) | 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 | Measured at 3, 12, 36, 48 and 60 months |
| Change in antihypertensive treatment (defined daily doses) | Measured at 3, 12, 24, 36, 48 and 60 months |
| Change in kidney function | Change in estimated glomerular filtration rate (eGFR) and change in percentage side distribution measured by renography at baseline and 24 months after PTRA | Measured at 3, 12, 24, 36, 48 and 60 months |
| Clinical composite end point | Clinical composite end point
Only the first event per participant is included in the composite | Measured at 3, 12, 24, 36, 48 and 60 months |
| Safety composite end point (< 30 days after PTRA) | Safety composite end point (< 30 days after PTRA)
Only the first event per participant is included in the composite | Measured at 3, 12, 24, 36, 48 and 60 months |
| Aarhus University Hospital | Recruiting | Aarhus N | 8200 | Denmark |
|
| Glostrup University Hospital/ Rigshospitalet | Recruiting | Glostrup Municipality | 2600 | Denmark |
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| Holbaek Hospital | Recruiting | Holbæk | 4300 | Denmark |
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| Odense University Hospital | Recruiting | Odense C | 5000 | Denmark |
|
| ID | Term |
|---|---|
| D012078 | Renal Artery Obstruction |
| D006978 | Hypertension, Renovascular |
| D002318 | Cardiovascular Diseases |
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D006977 | Hypertension, Renal |
| D006973 | Hypertension |
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