National registry for renal angioplasty in patients with resistant hypertension
A Prospective Danish National Registry of Percutaneous Transluminal Renal Angioplasty in Patients With Renovascular Hypertension
This study is setting up a national registry in Denmark to track how well a procedure called renal angioplasty works for patients with high blood pressure caused by narrowed kidney arteries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 160 (estimated) |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Locations | 5 sites (Aalborg and 4 other locations) |
| Trial ID | NCT02770066 on ClinicalTrials.gov |
What this trial studies
This study establishes a prospective national registry in Denmark for patients undergoing percutaneous transluminal renal angioplasty (PTRA) due to renal artery stenosis. It aims to collect data from high-risk patients selected based on national criteria and follows a standardized protocol across three participating centers. The registry will monitor patient outcomes and blood pressure control post-procedure, providing valuable insights into the effectiveness of PTRA in this population.
Who should consider this trial
Good fit: Ideal candidates include patients with true resistant hypertension requiring multiple antihypertensive medications and those experiencing side effects from treatment.
Not a fit: Patients with mild hypertension or those who do not meet the criteria for renal artery stenosis evaluation may not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could improve treatment strategies for patients with resistant hypertension and renal artery stenosis.
How similar studies have performed: Other studies have shown success with similar approaches in managing renal artery stenosis, indicating potential for positive outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Aalborg and 4 other locations
- Aalborg University Hospital — Aalborg, Denmark (Recruiting)
- Aarhus University Hospital — Aarhus N, Denmark (Recruiting)
- Glostrup University Hospital/ Rigshospitalet — Glostrup Municipality, Denmark (Recruiting)
- Holbaek Hospital — Holbæk, Denmark (Recruiting)
- Odense University Hospital — Odense C, Denmark (Recruiting)
Study contacts
- Study coordinator: Mark Reinhard, PhD
- Email: m.reinhard@dadlnet.dk
- Phone: +45 7845 2455
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.