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New treatment option for Renovascular Hypertension
Official title Effects of Percutaneous Transluminal Renal Angioplasty of Atherosclerotic Renal Artery Stenosis in High-Risk Patients.
ClinicalTrials.gov ID: NCT05834803
What this study is testing
What is Optimal medical therapy (OMT)?
Optimal medical therapy (OMT) is an investigational medicine, being studied as a potential treatment for renovascular hypertension.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- Hospital admissions with acute decompensated heart failure (≥2 hospitalizations for heart failure or ≥1 hospitalizations for sudden, "flash"...
You likely can't join if
- 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.
See the full eligibility 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...
- 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...
- 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.
- Previous PTRA treatment.
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Aarhus N, Denmark
- Copenhagen, Denmark
- Odense C, Denmark
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aarhus N, Denmark; Copenhagen, Denmark; Odense C, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.