A Prospective Danish National Registry of PTRA in Patients With Renovascular Hypertension

Recruiting

• Conditions: Hypertension, Renovascular; Cardiovascular Diseases; Renal Artery Obstruction; Kidney Diseases

• Registration Number: NCT02770066
• Lead Sponsor: University of Aarhus

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 Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2016-05-09
• Study First Submitted QC: 2016-05-10
• Study First Posted: 2016-05-12
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-09
• Primary Completion: 2025-01
• Study Completion: 2030-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

All of the following:

1. At least one of the above eligibility criteria
2. Duplex doppler ultrasonography or renography investigations consistent with hemodynamically significant renal artery stenosis
3. CT angiography or renal arteriography with angiographic renal artery stenosis of ≥ 70 % reduction of the luminal diameter in at least one projection

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Exclusion Criteria

1. If angiography/arteriography, ultrasonography or renography is consistent with bilateral significant renal artery stenosis and only one side is treated with PTRA
2. 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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	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.

Secondary Outcome Measures

Name	Time	Method
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	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
Change in antihypertensive treatment (defined daily doses)	Measured at 3, 12, 24, 36, 48 and 60 months
Change in kidney function	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
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	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	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)	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
Clinical composite end point	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)	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

Trial Locations

Locations (5)

Holbaek Hospital; 🇩🇰 Holbaek, Denmark

Aalborg University Hospital; 🇩🇰 Aalborg, Denmark

Odense University Hospital; 🇩🇰 Odense C, Denmark

Aarhus University Hospital; 🇩🇰 Aarhus N, Denmark

Glostrup University Hospital/ Rigshospitalet; 🇩🇰 Glostrup, Denmark