Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05834803
Other study ID # DAN-PTRAII
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 26, 2023
Est. completion date June 1, 2027

Study information

Verified date May 2024
Source University of Aarhus
Contact Sebastian Nielsen, MD
Phone +45 40460321
Email sebane@rm.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date June 1, 2027
Est. primary completion date June 1, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Procedure:
Renal artery stenting
Optimal medical therapy and percutaneous transluminal renal angioplasty with stent placement.
Sham treatment
Optimal medical therapy and sham treatment.

Locations

Country Name City State
Denmark Aarhus University Hospital Aarhus N
Denmark Rigshospitalet Copenhagen
Denmark Odense University Hospital Odense C

Sponsors (7)

Lead Sponsor Collaborator
University of Aarhus Aarhus University Hospital, Amsterdam UMC, Odense University Hospital, Rigshospitalet, Denmark, The Augustinus Foundation, Denmark., The Novo Nordic Foundation

Country where clinical trial is conducted

Denmark, 

References & 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 Atheros — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6 months after PTRA/sham
Secondary 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. 6 months after PTRA/sham
Secondary 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. 6 months after PTRA/sham
Secondary 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. 6 months after PTRA/sham
Secondary 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.
6 months after PTRA/sham
Secondary 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. 6 months after PTRA/sham
Secondary 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.
6 months after PTRA/sham
Secondary 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
<30 days after PTRA/sham
See also
  Status Clinical Trial Phase
Recruiting NCT05196659 - Collaborative Quality Improvement (C-QIP) Study N/A
Recruiting NCT05654272 - Development of CIRC Technologies
Recruiting NCT05650307 - CV Imaging of Metabolic Interventions
Active, not recruiting NCT05896904 - Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction N/A
Completed NCT05077293 - Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
Recruiting NCT05631275 - The Role of Bioimpedance Analysis in Patients With Chronic Heart Failure and Systolic Ventricular Dysfunction
Enrolling by invitation NCT05564572 - Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology N/A
Enrolling by invitation NCT05009706 - Self-care in Older Frail Persons With Heart Failure Intervention N/A
Recruiting NCT04177199 - What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
Terminated NCT03615469 - Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY) N/A
Recruiting NCT06340048 - Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure Phase 1/Phase 2
Recruiting NCT05679713 - Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
Completed NCT04254328 - The Effectiveness of Nintendo Wii Fit and Inspiratory Muscle Training in Older Patients With Heart Failure N/A
Completed NCT03549169 - Decision Making for the Management the Symptoms in Adults of Heart Failure N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Enrolling by invitation NCT05538611 - Effect Evaluation of Chain Quality Control Management on Patients With Heart Failure
Recruiting NCT04262830 - Cancer Therapy Effects on the Heart
Completed NCT06026683 - Conduction System Stimulation to Avoid Left Ventricle Dysfunction N/A
Withdrawn NCT03091998 - Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support Phase 1
Recruiting NCT05564689 - Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy