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A Prospective Danish National Registry of PTRA in Patients With Renovascular Hypertension (DAN-PTRA)

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ClinicalTrials.gov Identifier: NCT02770066
Recruitment Status : Recruiting
First Posted : May 12, 2016
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
Mark Reinhard, University of Aarhus

Brief Summary:
A prospective Danish national registry of percutaneous transluminal renal angioplasty (PTRA) in high-risk patients with renal artery stenosis selected on the basis of common national criteria, and with a common follow-up protocol for all three Danish centres offering PTRA

Condition or disease Intervention/treatment
Renal Artery Obstruction Hypertension, Renovascular Cardiovascular Diseases Kidney Diseases Device: Percutaneous transluminal renal angioplasty

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Danish National Registry of Percutaneous Transluminal Renal Angioplasty in Patients With Renovascular Hypertension
Study Start Date : January 2015
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty


Intervention Details:
  • Device: Percutaneous transluminal renal angioplasty

    Angioplasty plus stenting (angioplasty in patients with fibromuscular dysplasia)

    Adjuvant therapy in atherosclerotic renal artery stenosis - at the discretion of the treating physician

    • Antiplatelet therapy (usually standard)
    • Cholesterol-lowering drugs (usually standard)
    • Antihypertensive treatment with angiotensin-converting-enzyme inhibitor or angiotensin-receptor blocker (normally not contraindicated)
    • Smoking cessation, diet and physical activity (usually standard)


Primary Outcome Measures :
  1. 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 ]

    Changes in 24-hour ambulatory systolic and diastolic blood pressures (calculated from hourly means) from baseline to 24 months after percutaneous transluminal renal angioplasty in patients with 24-hour ambulatory average systolic blood pressure ≥ 150 mmHg at baseline and with significant artery stenosis either

    1. Unilaterally (one or two kidneys)
    2. Bilaterally with treatment of both kidneys

    All 24-hour ambulatory blood pressure measurements are performed after nurse-administered medication. Likewise, it will below be inferred that renal artery stenosis is defined as in the primary endpoint.



Secondary Outcome Measures :
  1. 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 ]
    Changes in 24-hour ambulatory systolic and diastolic blood pressures (calculated from hourly means) from baseline to 24 months after percutaneous transluminal renal angioplasty in patients with 24-hour ambulatory average systolic blood pressure ≥ 130 mmHg at baseline and with significant artery stenosis

  2. 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 ]
    Changes in 24-hour ambulatory systolic and diastolic blood pressures (calculated from hourly means) (statistically adjusted for treatment changes) from baseline to 24 months after percutaneous transluminal renal angioplasty in patients with 24-hour ambulatory average systolic blood pressure ≥ 150 mmHg at baseline and with significant artery stenosis

  3. 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 (calculated from hourly means) (statistically adjusted for treatment changes) from baseline to 24 months after percutaneous transluminal renal angioplasty in patients with 24-hour ambulatory average systolic blood pressure ≥ 130 mmHg at baseline and with significant artery stenosis

  4. 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 ]
    Changes in 24-hour ambulatory systolic and diastolic blood pressures (unadjusted and statistically adjusted for treatment changes) from baseline to 3, 12, 36, 48 and 60 months after PTRA in patients with 24-hour ambulatory average systolic blood pressure ≥ 150 mmHg and in patients with 24-hour ambulatory average systolic blood pressure ≥ 130 mmHg

  5. Change in antihypertensive treatment (defined daily doses) [ Time Frame: Measured at 3, 12, 24, 36, 48 and 60 months ]
  6. Change in kidney function [ Time Frame: Measured at 3, 12, 24, 36, 48 and 60 months ]
    Change in estimated glomerular filtration rate (eGFR) and change in percentage side distribution measured by renography at baseline and 24 months after PTRA

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

    Clinical composite end point

    1. death from cardiovascular causes
    2. death from renal causes
    3. stroke
    4. myocardial infarction
    5. hospitalization for congestive heart failure
    6. progressive renal insufficiency (a reduction from baseline of 30% or more in eGFR)
    7. permanent renal-replacement therapy

    Only the first event per participant is included in the composite


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

    Safety composite end point (< 30 days after PTRA)

    1. all cause mortality
    2. rupture, dissection, perforation or occlusion of renal artery
    3. critical bleeding (need of blood transfusion)
    4. embolization
    5. significant loss of kidney function (reduction from baseline of 30% or more in eGFR)
    6. ipsilateral nephrectomy
    7. pseudoaneurysm formation
    8. stent thrombosis

    Only the first event per participant is included in the composite




Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
High-risk patients with renal artery stenosis
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02770066


Contacts
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Contact: Mark Reinhard, PhD +45 7845 2455 m.reinhard@dadlnet.dk
Contact: Kent L Christensen, MD, DMSc +45 7845 2455 klc@dadlnet.dk

Locations
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Denmark
Aalborg University Hospital Recruiting
Aalborg, Denmark, 9000
Contact: Niels Henrik Buus, MD, DMSc    +45 9766 3725    n.buus@rn.dk   
Principal Investigator: Niels Henrik Buus, MD, DMSc         
Aarhus University Hospital Recruiting
Aarhus N, Denmark, 8200
Contact: Mark Reinhard, MD, PhD    +45 4046 0321    m.reinhard@dadlnet.dk   
Contact: Kent L Christensen, MD, DMSc    +45 7845 2455    klc@dadlnet.dk   
Principal Investigator: Mark Reinhard, MD, PhD         
Principal Investigator: Kent L Christensen, MD, DMSc         
Glostrup University Hospital/ Rigshospitalet Recruiting
Glostrup, Denmark, 2600
Contact: Ulrik B Andersen, MD    +45 3863 3863    ulrik.bjoern.andersen@regionh.dk   
Contact: Jørgen Jeppesen, MD, DMSc    +45 3863 3863    Joergen.Jeppesen.01@regionh.dk   
Principal Investigator: Ulrik B Andersen, MD         
Principal Investigator: Jørgen Jeppesen, MD, DMSc         
Holbaek Hospital Recruiting
Holbaek, Denmark, 4300
Contact: Michael H Olsen, MD, DMSc       michael.olsen@dadlnet.dk   
Principal Investigator: Michael H Olsen, MD, DMSc         
Odense University Hospital Recruiting
Odense C, Denmark, 5000
Contact: Karoline Schousboe, MD, PhD    +45 5142 6110    Karoline.Schousboe@rsyd.dk   
Contact: Ib Abildgaard, MD, DMSc    +45 6611 3333    Ib.Abildgaard@rsyd.dk   
Principal Investigator: Karoline Schousboe, MD, PhD         
Principal Investigator: Ib Abildgaard, MD, DMSc         
Sponsors and Collaborators
University of Aarhus

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Responsible Party: Mark Reinhard, MD, PhD, University of Aarhus
ClinicalTrials.gov Identifier: NCT02770066     History of Changes
Other Study ID Numbers: DAN-PTRA
First Posted: May 12, 2016    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
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Hypertension
Kidney Diseases
Cardiovascular Diseases
Renal Artery Obstruction
Hypertension, Renovascular
Vascular Diseases
Urologic Diseases
Arterial Occlusive Diseases
Hypertension, Renal