A Prospective Danish National Registry of PTRA in Patients With Renovascular Hypertension (DAN-PTRA)

A Prospective Danish National Registry of Percutaneous Transluminal Renal Angioplasty in Patients With Renovascular Hypertension

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

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Kidney Diseases; Renal Artery Obstruction; Hypertension, Renovascular
• Intervention / Treatment: Device: Percutaneous transluminal renal angioplasty

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Mark Reinhard, PhD; Phone Number: +45 7845 2455; Email: m.reinhard@dadlnet.dk
• Study Contact Backup: Name: Kent L Christensen, MD, DMSc; Phone Number: +45 7845 2455; Email: klc@dadlnet.dk

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Recruiting
    • Aalborg University Hospital
    • Contact: Niels Henrik Buus, MD, DMSc; Phone Number: +45 9766 3725; Email: n.buus@rn.dk
    • Principal Investigator: Niels Henrik Buus, MD, DMSc
  • Aarhus N, Denmark, 8200
    • Recruiting
    • Aarhus University Hospital
    • Contact: Kent L Christensen, MD, DMSc; Phone Number: +45 7845 2455; Email: klc@dadlnet.dk
    • Contact: Mark Reinhard, MD, PhD; Phone Number: +45 4046 0321; Email: m.reinhard@dadlnet.dk
    • Principal Investigator: Mark Reinhard, MD, PhD
    • Principal Investigator: Kent L Christensen, MD, DMSc
  • Glostrup, Denmark, 2600
    • Recruiting
    • Glostrup University Hospital/ Rigshospitalet
    • Contact: Ulrik B Andersen, MD; Phone Number: +45 3863 3863; Email: ulrik.bjoern.andersen@regionh.dk
    • Contact: Jørgen Jeppesen, MD, DMSc; Phone Number: +45 3863 3863; Email: Joergen.Jeppesen.01@regionh.dk
    • Principal Investigator: Ulrik B Andersen, MD
    • Principal Investigator: Jørgen Jeppesen, MD, DMSc
  • Holbaek, Denmark, 4300
    • Recruiting
    • Holbaek Hospital
    • Contact: Michael H Olsen, MD, DMSc; Email: michael.olsen@dadlnet.dk
    • Principal Investigator: Michael H Olsen, MD, DMSc
  • Odense C, Denmark, 5000
    • Recruiting
    • Odense University Hospital
    • Contact: Karoline Schousboe, MD, PhD; Phone Number: +45 5142 6110; Email: Karoline.Schousboe@rsyd.dk
    • Contact: Ib Abildgaard, MD, DMSc; Phone Number: +45 6611 3333; Email: Ib.Abildgaard@rsyd.dk
    • Principal Investigator: Karoline Schousboe, MD, PhD
    • Principal Investigator: Ib Abildgaard, MD, DMSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

High-risk patients with renal artery stenosis

Description

Eligibility criteria

1. True resistant hypertension (≥ 3 antihypertensive drugs including a diuretic, if tolerated, and each prescribed at optimal doses) and uncontrolled blood pressure confirmed by 24-hour ambulatory blood pressure monitoring. The 24-hour ambulatory blood pressure monitoring is performed after nurse-administered medication and blood pressure measurements are performed hourly. If the average 24-hour ambulatory systolic blood pressure is ≥ 130 mmHg the patient can be evaluated for renal artery stenosis.
2. Hypertension and intolerance or side effects of the antihypertensive treatment. Hypertension is confirmed by 24-hour ambulatory blood pressure monitoring. The 24-hour ambulatory blood pressure monitoring is performed after nurse-administered medication and blood pressure measurements are performed hourly. If the average 24-hour ambulatory systolic blood pressure is ≥ 130 mmHg the patient can be evaluated for renal artery stenosis.
3. Progressive renal insufficiency (a reduction in eGFR > 5 ml/min/1,73 m2 per year) in patients with bilateral renal artery stenosis or in patients with renal artery stenosis and only one kidney.
4. Recurrent heart failure/pulmonary edema and resistant hypertension (≥ 3 antihypertensive drugs including a diuretic, if tolerated, and each prescribed at optimal doses) that may not be attributed to non-compliance, reduced left heart ventricular ejection fraction/heart valve disease or other obvious explanations (atrial fibrillation, fever, hyperthyroidism etc.). If the average 24-hour ambulatory systolic blood pressure is ≥ 130 mmHg after nurse-administered medication the patient can be evaluated for renal artery stenosis.
5. Younger patients (< 40 years) with hypertension (24-hour ambulatory blood pressure monitoring ≥ 130/80 mmHg after nurse-administered medication )

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

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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; 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.	Measured 24 months post-PTRA

Secondary Outcome Measures

Outcome Measure	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	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; 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	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); 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	Measured at 3, 12, 24, 36, 48 and 60 months

Collaborators and Investigators

• Sponsor: University of Aarhus

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): January 1, 2025
• Study Completion (Anticipated): January 1, 2030

Study Registration Dates

• First Submitted: May 9, 2016
• First Submitted That Met QC Criteria: May 10, 2016
• First Posted (Estimate): May 12, 2016

Study Record Updates

• Last Update Posted (Actual): November 7, 2022
• Last Update Submitted That Met QC Criteria: November 4, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Arterial Occlusive Diseases; Urologic Diseases; Hypertension, Renal; Hypertension; Cardiovascular Diseases; Kidney Diseases; Renal Artery Obstruction; Hypertension, Renovascular
• Other Study ID Numbers: DAN-PTRA