A Prospective Danish National Registry of PTRA in Patients With Renovascular Hypertension

• Register: ClinicalTrials.gov
• Last refreshed on: 14 November 2022
• Main ID: NCT02770066
• Date of registration: 09/05/2016
• Prospective Registration: No
• Primary sponsor: University of Aarhus
• Public title: A Prospective Danish National Registry of PTRA in Patients With Renovascular Hypertension DAN-PTRA
• Scientific title: A Prospective Danish National Registry of Percutaneous Transluminal Renal Angioplasty in Patients With Renovascular Hypertension
• Date of first enrolment: January 2015
• Target sample size: 30
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02770066
• Study type: Observational

Countries of recruitment

Denmark

Contacts

• Name: Mark Reinhard, PhD

Key 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)



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cardiovascular Diseases

Kidney Diseases

Hypertension, Renovascular

Renal Artery Obstruction

Intervention(s)

Device: Percutaneous transluminal renal angioplasty

Primary Outcome(s)

Changes in 24-hour ambulatory systolic and diastolic blood pressures from baseline to 24 months after PTRA in patients with 24-hour ambulatory average systolic blood pressure = 150 mmHg at baseline [Time Frame: Measured 24 months post-PTRA]

Secondary Outcome(s)

Safety composite end point (< 30 days after PTRA) [Time Frame: Measured at 3, 12, 24, 36, 48 and 60 months]

Changes in 24-hour ambulatory systolic and diastolic blood pressures (statistically adjusted for treatment changes) from baseline to 24 months after PTRA in patients with 24-hour ambulatory average systolic blood pressure = 130 mmHg at baseline [Time Frame: Measured 24 months post-PTRA]

Changes in 24-hour ambulatory systolic and diastolic blood pressures (unadjusted and statistically adjusted for treatment changes) [Time Frame: Measured at 3, 12, 36, 48 and 60 months]

Change in kidney function [Time Frame: Measured at 3, 12, 24, 36, 48 and 60 months]

Changes in 24-hour ambulatory systolic and diastolic blood pressures (statistically adjusted for treatment changes) from baseline to 24 months after PTRA in patients with 24-hour ambulatory average systolic blood pressure = 150 mmHg at baseline [Time Frame: Measured 24 months post-PTRA]

Change in antihypertensive treatment (defined daily doses) [Time Frame: Measured at 3, 12, 24, 36, 48 and 60 months]

Changes in 24-hour ambulatory systolic and diastolic blood pressures from baseline to 24 months after PTRA in patients with 24-hour ambulatory average systolic blood pressure = 130 mmHg at baseline [Time Frame: Measured 24 months post-PTRA]

Clinical composite end point [Time Frame: Measured at 3, 12, 24, 36, 48 and 60 months]

Secondary ID(s)

DAN-PTRA

Source(s) of Monetary Support

Please refer to primary and secondary sponsors