Arterial Stiffness as a Predictor of Response to Renal Sympathetic Denervation (EFFECTIVENES)
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ClinicalTrials.gov Identifier: NCT02772939 |
Recruitment Status :
Active, not recruiting
First Posted : May 16, 2016
Last Update Posted : February 4, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Therapy Resistant Arterial Hypertension | Device: Renal sympathetic denervation (RDN) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 80 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Evaluation of Arterial Stiffness as a Predictor of Response to Renal Sympathetic Denervation |
Study Start Date : | June 2015 |
Actual Primary Completion Date : | September 2020 |
Estimated Study Completion Date : | May 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Renal Denervation
Renal denervation for therapy resistant arterial hypertension
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Device: Renal sympathetic denervation (RDN)
Catheter based renal sympathetic denervation for therapy resistant arterial hypertension |
- Predictive value of invasive Pulse wave velocity for blood pressure response after renal denervation [ Time Frame: 3 Months ]difference in daytime blood pressure (ABPM) between patients with low (<14.4 m/s) vs. high invasive pulse wave velocity
- Predictive value of noninvasive and invasive measures of arterial stiffness (Pulse wave velocity assessed invasively, with a piezoelectric device and MRI-based) in combination with clinical variables [ Time Frame: 3 Months ]AUC of ROCs for noninvasive and invasive measures of arterial stiffness in predicting blood pressure response to renal denervation
- Change in 24h ambulatory blood pressure [ Time Frame: 3 months, 6 months, 12 months ]
- Change in exercise blood pressure [ Time Frame: 3 months ]
- Predictive value of MRI-assessed aortic distensibility on Change in daytime ambulatory blood pressure [ Time Frame: 3 months, 6 months, 12 months ]
- Predictive value of MRI-assessed aortic distensibility on Change in 24 h ambulatory blood pressure [ Time Frame: 3 months, 6 months, 12 months ]
- Predictive value of MRI-assessed total arterial compliance on Change in daytime ambulatory blood pressure [ Time Frame: 3 months, 6 months, 12 months ]
- Predictive value of MRI-assessed total arterial compliance on Change in 24 h ambulatory blood pressure [ Time Frame: 3 months, 6 months, 12 months ]
- comparison of predictive value of invasive pulse wave velocity, invasive central pulse pressure, noninvasive pulse wave velocity, noninvasive central pulse pressure, aortic distensibility, total arterial compliance for Change in ambulatory blood pressure [ Time Frame: 3 months, 6 months, 12 months ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with therapy resistant arterial hypertension (>=3 antihypertensive drugs including at least one diuretic without any dosage change in the preceding 4 weeks) and office BP >160 mmHg systolic or 90 mmHg diastolic
Exclusion Criteria:
- average systolic daytime BP <135 mmHg in 24h ambulatory blood pressure measurement (ABPM)
- pregnancy
- known renal artery stenosis
- >= 1 renal artery diameter < 4 mm
- life expectancy <6 months
- participation in any other clinical trial

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): NCT02772939
Germany | |
Heart Center of the University Leipzig | |
Leipzig, Germany, 04289 |
Responsible Party: | Philipp Lurz, Philipp Lurz, PhD, MD, University of Leipzig |
ClinicalTrials.gov Identifier: | NCT02772939 |
Other Study ID Numbers: |
Effectiveness0001 |
First Posted: | May 16, 2016 Key Record Dates |
Last Update Posted: | February 4, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Hypertension Vascular Diseases Cardiovascular Diseases |