Clinical Trial: A Prospective Danish National Registry of PTRA in Patients With Renovascular Hypertension
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: A Prospective Danish National Registry of Percutaneous Transluminal Renal Angioplasty in Patients With Renovascular Hypertension
Brief Summary: 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
Detailed Summary:
Sponsor: University of Aarhus
Current Primary Outcome: 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 [ Time Frame: Measured 24 months post-PTRA ]
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
- Unilaterally (one or two kidneys)
- Bilaterally with treatment of both kidneys
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.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 [ Time Frame: Measured 24 months post-PTRA ]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
- 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 [ Time Frame: Measured 24 months post-PTRA ]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
- 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 [ Time Frame: Measured 24 months post-PTRA ]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
- Changes in 24-hour ambulatory systolic and diastolic blood pressures (unadjusted and statistically adjusted for treatment changes) [ Time Frame: Measured at 3, 12, 36, 48 and 60 months ]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
- Change in antihypertensive treatment (defined daily doses) [ Time Frame: Measured at 3, 12, 24, 36, 48 and 60 months ]
- Change in kidney function [ Time Frame: Measured at 3, 12, 24, 36, 48 and 60 months ]Change in estimated glomerular filtration rate (eGFR) and change in percentage side distribution measured by renography at baseline and 24 months after PTRA
- Clinical composite end point [ Time Frame: Measured at 3, 12, 24, 36, 48 and 60 months ]
Clinical composite end point
- death from cardiovascular causes
- death from renal causes
- stroke
- myocardial infarction
- hospitalization for congestive heart failure
- progressive renal insufficiency (a reduction from baseline of 30% or more in eGFR)
- permanent renal-replacement therapy
Only the first event per participant is included in the composite
- Safety composite end point (< 30 days after PTRA) [ Time Frame: Measured at 3, 12, 24, 36, 48 and 60 months ]
Safety composite end point (< 30 days after PTRA)
- all cause mortality
- rupture, dissection, perforation or occlusion of renal artery
- critical bleeding (need of blood transfusion)
- embolization
- significant loss of kidney function (reduction from baseline of 30% or more in eGFR)
- ipsilateral nephrectomy
- pseudoaneurysm formation
- stent thrombosis
Only the first event per participant is included in the composite
Original Secondary Outcome: Same as current
Information By: University of Aarhus
Dates:
Date Received: May 9, 2016
Date Started: January 2015
Date Completion: January 2030
Last Updated: May 10, 2016
Last Verified: May 2016