Effects of Percutaneous Transluminal Renal Angioplasty of Atherosclerotic Renal Artery Stenosis in High-Risk Patients - a Danish Nationwide Randomized Sham-Controlled Study.

Plain English Summary

Effects of Percutaneous Transluminal Renal Angioplasty of Atherosclerotic Renal Artery Stenosis in High-Risk Patients. is a Not Applicable clinical trial sponsored by University of Aarhus studying Renovascular Hypertension, Renovascular Hypertension With Renal Failure, Heart Failure, Renal Artery Stenosis Atherosclerotic, Percutaneous Transluminal Angioplasty. This trial tests if opening narrowed kidney arteries with a stent improves blood pressure, kidney function, and reduces hospital stays for heart failure. It is for high-risk patients with severe narrowing of their kidney arteries and specific health problems like very high blood pressure, worsening kidney function, or heart failure. Participation involves a procedure to open the kidney artery, which may be a real stent placement or a sham procedure (no treatment), followed by regular check-ups. Alternatives include optimal medical treatment alone, which involves managing blood pressure and other conditions with medications. The trial aims to enroll 80 participants.

Official 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

Who Can Participate

Here is what you need to know about eligibility for this trial. You may be eligible if you have a severe blockage (70% or more) in your kidney arteries. You must also have at least one of these: very high blood pressure despite medication, rapidly worsening kidney function, or recent hospitalizations for heart failure. You cannot join if you are pregnant, have had a kidney transplant, have had previous treatment for this condition, or have kidney size issues. This trial is studying Renovascular Hypertension, Renovascular Hypertension With Renal Failure, Heart Failure, Renal Artery Stenosis Atherosclerotic, Percutaneous Transluminal Angioplasty, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures how much the procedure affects systolic blood pressure, indicating if it helps lower dangerously high blood pressure. The specific primary outcome measures are: Change in 24-hour ambulatory systolic blood pressure. (Baseline and 6 months.). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial matters because it aims to find a better treatment for patients with severe kidney artery narrowing who are at high risk for serious health problems, addressing a gap in understanding the b This research targets Renovascular Hypertension, Renovascular Hypertension With Renal Failure, Heart Failure, Renal Artery Stenosis Atherosclerotic, Percutaneous Transluminal Angioplasty, where improved treatment options are needed.

Investor Insight

This trial focuses on a specific, high-risk patient group, suggesting a potential for a targeted therapy if proven effective, which could impact the market for cardiovascular and renal interventions.

Is This Trial Right for Me?

Ask your doctor if opening your kidney artery is right for you and what the risks and benefits are. Understand that you might receive a real stent or a sham procedure, and you will have regular follow-up appointments to monitor your health. Be prepared for potential blood tests, blood pressure monitoring, and imaging scans as part of the trial. This trial is currently recruiting participants. The trial is being conducted at 3 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: TRIPLE
• Enrollment: 80 participants

Interventions

• DRUG: Optimal medical therapy (OMT) — Optimal medical therapy, including maximally tolerated renin-angiotensin system blockade with either an angiotensin-converting enzyme inhibitor or an angiotensin II receptor blocker.
• DIAGNOSTIC_TEST: Catheter-based angiography — Catheter-based angiography performed in accordance with the study protocol.
• DIAGNOSTIC_TEST: Measurement of translesional pressure gradients — Measurement of translesional pressure gradients performed in accordance with the study protocol.
• PROCEDURE: Renal artery stenting — Renal artery stenting performed in accordance with the study protocol.
• PROCEDURE: Sham (No Treatment) — Sham procedure performed in accordance with the study protocol.

Primary Outcomes

• Change in 24-hour ambulatory systolic blood pressure. (Baseline and 6 months.)

Secondary Outcomes

• Change in estimated glomerular filtration rate (eGFR). (Baseline, Day 1, Day 7, Day 21, 6 weeks, 3 months, 4.5 months, and 6 months.)
• Change in antihypertensive treatment. (Baseline, 3 months, and 6 months.)
• Change in 24-hour ambulatory systolic blood pressure (statistically adjusted for treatment changes). (Baseline, 3 months, and 6 months.)
• Number of participants with cardiovascular and kidney outcomes. (From baseline to 6 months after PTRA/sham.)
• Number of deaths from any cause. (From baseline to 6 months after PTRA/sham.)

Full Eligibility Criteria

Inclusion Criteria:

1. One or more severe atherosclerotic renal artery stenoses defined as a stenosis ≥70% by catheter-based angiography.
2. In addition, at least one of the following high-risk clinical syndromes:

   1. 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.
   2. 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.
   3. 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.
* 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 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:

1. Treatment-resistant heart failure episodes presumed caused by renovascular disease.
2. Rapidly declining kidney function/acute kidney failure approaching the need for dialysis presumed caused by renovascular disease.
3. 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

Trial Locations

• Aarhus University Hospital, Aarhus N, Denmark
• Rigshospitalet, Copenhagen, Denmark
• Odense University Hospital, Odense C, Denmark

Frequently Asked Questions

Related Conditions

• Renovascular Hypertension
• Renovascular Hypertension With Renal Failure
• Heart Failure
• Renal Artery Stenosis Atherosclerotic
• Percutaneous Transluminal Angioplasty
• Hypertension
• Kidney Disease
• Cardiovascular Disease
• Atherosclerosis
• Vascular Stenosis

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