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

  1. Unilaterally (one or two kidneys)
  2. 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

    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 30% or more in eGFR)
    7. 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)

    1. all cause mortality
    2. rupture, dissection, perforation or occlusion of renal artery
    3. critical bleeding (need of blood transfusion)
    4. embolization
    5. significant loss of kidney function (reduction from baseline of 30% or more in eGFR)
    6. ipsilateral nephrectomy
    7. pseudoaneurysm formation
    8. 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