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

NCT02770066 | Recruiting

• 1 other identifier: DAN-PTRA
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 5

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

Conditions

Hypertension, Renovascular; Cardiovascular Diseases; Kidney Diseases; Renal Artery Obstruction

Outcome Measures

Primary Outcomes (1)

• 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 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.

  Measured 24 months post-PTRA

Secondary Outcomes (8)

• 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 (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 (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 (unadjusted and statistically adjusted for treatment changes)

  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

Interventions

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 * Antiplatelet therapy (usually standard) * Cholesterol-lowering drugs (usually standard) * Antihypertensive treatment with angiotensin-converting-enzyme inhibitor or angiotensin-receptor blocker (normally not contraindicated) * Smoking cessation, diet and physical activity (usually standard)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

High-risk patients with renal artery stenosis

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (5)

Aalborg University Hospital

Aalborg, 9000, Denmark

RECRUITING

Aarhus University Hospital

Aarhus N, 8200, Denmark

RECRUITING

Glostrup University Hospital/ Rigshospitalet

Glostrup Municipality, 2600, Denmark

RECRUITING

Holbaek Hospital

Holbæk, 4300, Denmark

RECRUITING

Odense University Hospital

Odense C, 5000, Denmark

RECRUITING

Related Publications (1)

• 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.

  PMID: 35322677 DERIVED

MeSH Terms

Conditions

Renal Artery Obstruction; Hypertension, Renovascular; Cardiovascular Diseases; Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Arterial Occlusive Diseases; Vascular Diseases; Hypertension, Renal; Hypertension

Central Study Contacts

Mark Reinhard, PhD

CONTACT

+45 7845 2455; m.reinhard@dadlnet.dk

Kent L Christensen, MD, DMSc

CONTACT

+45 7845 2455; klc@dadlnet.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 9, 2016
• First Posted: May 12, 2016
• Study Start: January 1, 2015
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2035
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

DK (5)