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Effects of Percutaneous Transluminal Renal Angioplasty of Atherosclerotic Renal Artery Stenosis in High-Risk Patients. (DAN-PTRAII)

Primary Purpose

Renovascular Hypertension, Renovascular Hypertension With Renal Failure, Heart Failure

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Renal artery stenting
Sham treatment
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renovascular Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: One or more severe atherosclerotic renal artery stenoses defined as a stenosis ≥70% by catheter-based angiography. In addition, at least one of the following high-risk clinical syndromes: Resistant hypertension with average 24-hour ambulatory systolic blood pressure ≥150 mmHg despite ≥3 antihypertensive drugs including a diuretic, if tolerated, and each prescribed at optimal doses. Rapidly declining kidney function with a reduction in estimated GFR of >5 mL/min per 1.73m2 per year and average 24-hour ambulatory systolic blood pressure ≥140 mmHg despite ≥3 antihypertensive drugs including a diuretic, if tolerated, and each prescribed at optimal doses. Hospital admissions with acute decompensated heart failure (≥2 hospitalizations for heart failure or ≥1 hospitalizations for sudden, "flash" pulmonary edema) with no obvious explanations such as nonadherence, left ventricular ejection fraction <40%, or valvular heart disease and average 24-hour ambulatory systolic blood pressure ≥140 mmHg despite ≥3 antihypertensive drugs including a diuretic, if tolerated, and each prescribed at optimal doses. All 24-hour ambulatory blood pressure monitorings are performed after nurse-administered medication. Exclusion Criteria: Unable to provide informed consent. Treatment resistant heart failure episodes presumed caused by renovascular disease. Rapidly declining kidney function/acute kidney failure approaching the need for dialysis presumed caused by renovascular disease. Fibromuscular dysplasia or other non-atherosclerotic renal artery stenosis known to be present prior to randomization. Pregnancy or unknown pregnancy status in female of childbearing potential. Kidney size <7 cm (pole to pole length) supplied by target vessel. Previous kidney transplant. Presence of a renal artery stenosis not amenable for treatment with a stent. Patients who are not eligible for randomization but treated with renal artery stenting outside the protocol are followed according to the DAN-PTRAII protocol in order to account for all PTRA treatments performed in Denmark in the study period. Patients treated with renal artery stenting without randomization in the study period include patients with: Treatment resistant heart failure episodes presumed caused by renovascular disease. Rapidly declining kidney function/acute kidney failure approaching the need for dialysis presumed caused by renovascular disease. At least one of the listed high-risk clinical syndromes AND one or more significant atherosclerotic renal artery stenoses defined as a stenosis of 50-69% by catheter-based angiography with: a mean translesional gradient of ≥10 mm Hg, or a systolic translesional gradient of ≥20 mm Hg, or a renal fractional flow reserve (Pd/Pa) of ≤0.8

Sites / Locations

  • Aarhus University HospitalRecruiting
  • RigshospitaletRecruiting
  • Odense University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Renal artery stenting

Sham treatment

Arm Description

Percutaneous transluminal renal angioplasty with stent placement.

Sham treatment.

Outcomes

Primary Outcome Measures

Changes in 24-hour ambulatory systolic blood pressure.
Changes in 24-hour ambulatory systolic blood pressure from baseline to 6 months after renal artery stenting compared with optimal medical treatment alone in patients with 24-hour ambulatory average systolic blood pressure ≥150 mmHg at baseline.

Secondary Outcome Measures

Changes in kidney function.
Changes in kidney function (estimated glomerular filtration rate) from baseline to 6 months after renal artery stenting compared with optimal medical treatment alone.
Changes in antihypertensive treatment (defined daily doses).
Changes in antihypertensive treatment (defined daily doses) from baseline to 6 months after renal artery stenting compared with optimal medical treatment alone.
Changes in 24-hour ambulatory systolic blood pressure (statistically adjusted for treatment changes).
Changes in 24-hour ambulatory systolic blood pressure from baseline to 6 months after renal artery stenting compared with optimal medical treatment alone in patients with 24-hour ambulatory average systolic blood pressure ≥150 mmHg at baseline. Changes in systolic blood pressure will be adjusted for changes in the defined daily doses (DDD) of antihypertensive medications, where a change of 1DDD equals a change of 5 mmHg in the systolic blood pressure.
Number of participants with cardiovascular and kidney outcomes.
Clinical events included in the composite end point from baseline to 6-month follow-up: death from cardiovascular causes death from renal causes stroke myocardial infarction hospitalization for congestive heart failure progressive renal insufficiency (a reduction from baseline of 50% or more in estimated GFR) permanent renal-replacement therapy Clinical events are defined using the same criteria as in the Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL) study except for progressive renal insufficiency (in the CORAL study defined as a reduction from baseline of 30% or more in the estimated GFR). Only the first event per participant is included in the composite.
Number of deaths from any cause.
Death from any cause from baseline to 6 months after renal artery stenting compared with optimal medical treatment alone.
Health status on 12-Item Short Form Survey (SF-12).
Changes in 12-item short form health survey (SF-12) from baseline to 6 months after renal artery stenting compared with optimal medical treatment alone. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
Number of participants with procedure-related major adverse events (MAE) <30 days of PTRA/sham.
Number of participants with procedure-related MAEs including: 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 50% or more in eGFR) permanent renal-replacement therapy ipsilateral nephrectomy access complications requiring treatment: bleeding, pseudoaneurysm or thrombosis stent thrombosis after renal artery stenting

Full Information

First Posted
April 3, 2023
Last Updated
May 1, 2023
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital, Rigshospitalet, Denmark, Odense University Hospital, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), The Novo Nordic Foundation, The Augustinus Foundation, Denmark.
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1. Study Identification

Unique Protocol Identification Number
NCT05834803
Brief Title
Effects of Percutaneous Transluminal Renal Angioplasty of Atherosclerotic Renal Artery Stenosis in High-Risk Patients.
Acronym
DAN-PTRAII
Official Title
Effects of Percutaneous Transluminal Renal Angioplasty of Atherosclerotic Renal Artery Stenosis in High-Risk Patients - a Danish Nationwide Randomized Sham-Controlled Study.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Anticipated)
Primary Completion Date
May 1, 2027 (Anticipated)
Study Completion Date
May 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital, Rigshospitalet, Denmark, Odense University Hospital, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), The Novo Nordic Foundation, The Augustinus Foundation, Denmark.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this clinical trial is to document a beneficial effect of percutaneous transluminal renal angioplasty (PTRA) of atherosclerotic renal artery stenosis in high-risk patients selected according to the criteria used in the DAN-PTRA study. The main questions the trial aims to answer are if renal artery stenting compared with optimal medical treatment alone has beneficial effects on: Blood pressure Kidney function Hospitalizations for heart failure
Detailed Description
Even with optimal medical care, patients with renovascular disease have a very high risk of cardiovascular events and an expected poor outcome. One treatment option of atherosclerotic renal artery stenosis is percutaneous transluminal renal angioplasty with stent placement. Renal artery stenting is, however, still a subject of debate as randomized trials have failed to show a benefit of this compared with optimal medical treatment alone. Following the results of the large CORAL trial in 2014, we established the national prospective DAN-PTRA study using strict and well-defined criteria to select patients for renal artery stenting. In this study, we observed a reduction in blood pressure, an improved kidney function, and a decrease in new hospital admissions due to heart failure after renal artery stenting. The DAN-PTRAII study is a nationwide high-quality randomized, sham-controlled clinical trial in patients with severe renovascular disease due to atherosclerotic renal artery stenosis. Only patients who fulfill the inclusion criteria on optimal medical treatment can enter the study and only the operator and his team will know whether the patients receive renal artery stenting or sham treatment. Participants will be followed closely for 6 months after the treatment to evaluate the effects of renal artery stenting compared with optimal medical treatment alone on blood pressure, kidney function and hospitalizations due to heart failure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renovascular Hypertension, Renovascular Hypertension With Renal Failure, Heart Failure, Renal Artery Stenosis Atherosclerotic, Percutaneous Transluminal Angioplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A Danish Nationwide (3-center) Randomized and Sham-Controlled Study.
Masking
ParticipantCare ProviderInvestigator
Masking Description
Only the operator and his team will know whether the patient receives active treatment or sham treatment. The patient will wear a sleep mask and earplugs during the procedure to ensure blinding. Pressure gradient measurements will be performed in both groups.
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Renal artery stenting
Arm Type
Active Comparator
Arm Description
Percutaneous transluminal renal angioplasty with stent placement.
Arm Title
Sham treatment
Arm Type
Sham Comparator
Arm Description
Sham treatment.
Intervention Type
Procedure
Intervention Name(s)
Renal artery stenting
Intervention Description
Optimal medical therapy and percutaneous transluminal renal angioplasty with stent placement.
Intervention Type
Procedure
Intervention Name(s)
Sham treatment
Intervention Description
Optimal medical therapy and sham treatment.
Primary Outcome Measure Information:
Title
Changes in 24-hour ambulatory systolic blood pressure.
Description
Changes in 24-hour ambulatory systolic blood pressure from baseline to 6 months after renal artery stenting compared with optimal medical treatment alone in patients with 24-hour ambulatory average systolic blood pressure ≥150 mmHg at baseline.
Time Frame
6 months after PTRA/sham
Secondary Outcome Measure Information:
Title
Changes in kidney function.
Description
Changes in kidney function (estimated glomerular filtration rate) from baseline to 6 months after renal artery stenting compared with optimal medical treatment alone.
Time Frame
6 months after PTRA/sham
Title
Changes in antihypertensive treatment (defined daily doses).
Description
Changes in antihypertensive treatment (defined daily doses) from baseline to 6 months after renal artery stenting compared with optimal medical treatment alone.
Time Frame
6 months after PTRA/sham
Title
Changes in 24-hour ambulatory systolic blood pressure (statistically adjusted for treatment changes).
Description
Changes in 24-hour ambulatory systolic blood pressure from baseline to 6 months after renal artery stenting compared with optimal medical treatment alone in patients with 24-hour ambulatory average systolic blood pressure ≥150 mmHg at baseline. Changes in systolic blood pressure will be adjusted for changes in the defined daily doses (DDD) of antihypertensive medications, where a change of 1DDD equals a change of 5 mmHg in the systolic blood pressure.
Time Frame
6 months after PTRA/sham
Title
Number of participants with cardiovascular and kidney outcomes.
Description
Clinical events included in the composite end point from baseline to 6-month follow-up: death from cardiovascular causes death from renal causes stroke myocardial infarction hospitalization for congestive heart failure progressive renal insufficiency (a reduction from baseline of 50% or more in estimated GFR) permanent renal-replacement therapy Clinical events are defined using the same criteria as in the Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL) study except for progressive renal insufficiency (in the CORAL study defined as a reduction from baseline of 30% or more in the estimated GFR). Only the first event per participant is included in the composite.
Time Frame
6 months after PTRA/sham
Title
Number of deaths from any cause.
Description
Death from any cause from baseline to 6 months after renal artery stenting compared with optimal medical treatment alone.
Time Frame
6 months after PTRA/sham
Title
Health status on 12-Item Short Form Survey (SF-12).
Description
Changes in 12-item short form health survey (SF-12) from baseline to 6 months after renal artery stenting compared with optimal medical treatment alone. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
Time Frame
6 months after PTRA/sham
Title
Number of participants with procedure-related major adverse events (MAE) <30 days of PTRA/sham.
Description
Number of participants with procedure-related MAEs including: 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 50% or more in eGFR) permanent renal-replacement therapy ipsilateral nephrectomy access complications requiring treatment: bleeding, pseudoaneurysm or thrombosis stent thrombosis after renal artery stenting
Time Frame
<30 days after PTRA/sham

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: One or more severe atherosclerotic renal artery stenoses defined as a stenosis ≥70% by catheter-based angiography. In addition, at least one of the following high-risk clinical syndromes: Resistant hypertension with average 24-hour ambulatory systolic blood pressure ≥150 mmHg despite ≥3 antihypertensive drugs including a diuretic, if tolerated, and each prescribed at optimal doses. Rapidly declining kidney function with a reduction in estimated GFR of >5 mL/min per 1.73m2 per year and average 24-hour ambulatory systolic blood pressure ≥140 mmHg despite ≥3 antihypertensive drugs including a diuretic, if tolerated, and each prescribed at optimal doses. Hospital admissions with acute decompensated heart failure (≥2 hospitalizations for heart failure or ≥1 hospitalizations for sudden, "flash" pulmonary edema) with no obvious explanations such as nonadherence, left ventricular ejection fraction <40%, or valvular heart disease and average 24-hour ambulatory systolic blood pressure ≥140 mmHg despite ≥3 antihypertensive drugs including a diuretic, if tolerated, and each prescribed at optimal doses. All 24-hour ambulatory blood pressure monitorings are performed after nurse-administered medication. Exclusion Criteria: Unable to provide informed consent. Treatment resistant heart failure episodes presumed caused by renovascular disease. Rapidly declining kidney function/acute kidney failure approaching the need for dialysis presumed caused by renovascular disease. Fibromuscular dysplasia or other non-atherosclerotic renal artery stenosis known to be present prior to randomization. Pregnancy or unknown pregnancy status in female of childbearing potential. Kidney size <7 cm (pole to pole length) supplied by target vessel. Previous kidney transplant. Presence of a renal artery stenosis not amenable for treatment with a stent. Patients who are not eligible for randomization but treated with renal artery stenting outside the protocol are followed according to the DAN-PTRAII protocol in order to account for all PTRA treatments performed in Denmark in the study period. Patients treated with renal artery stenting without randomization in the study period include patients with: Treatment resistant heart failure episodes presumed caused by renovascular disease. Rapidly declining kidney function/acute kidney failure approaching the need for dialysis presumed caused by renovascular disease. At least one of the listed high-risk clinical syndromes AND one or more significant atherosclerotic renal artery stenoses defined as a stenosis of 50-69% by catheter-based angiography with: a mean translesional gradient of ≥10 mm Hg, or a systolic translesional gradient of ≥20 mm Hg, or a renal fractional flow reserve (Pd/Pa) of ≤0.8
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sebastian Nielsen, MD
Phone
+45 40460321
Email
sebane@rm.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Reinhard, MD, PhD
Phone
+45 40460321
Email
m.reinhard@dadlnet.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Reinhard, MD, PhD
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sebastian Nielsen, MD
Email
sebane@rm.dk
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonas P Eiberg, MD, PhD
Email
jonas.peter.eiberg@regionh.dk
Facility Name
Odense University Hospital
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steen Bonnema, MD, DMSc
Email
steen.bonnema@rsyd.dk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35322677
Citation
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. Erratum In: J Am Heart Assoc. 2023 Apr 18;12(8):e020845.
Results Reference
result

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Effects of Percutaneous Transluminal Renal Angioplasty of Atherosclerotic Renal Artery Stenosis in High-Risk Patients.

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