How to Test Success of a Renal Denervation

Testing Effectiveness of Renal Denervation in Patients With Therapy-resistant Hypertension

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02559882

Enrollment

Registered

2015-09-25

Start date

2015-08-31

Completion date

2018-12-21

Last updated

2019-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Resistant to Conventional Therapy

Brief summary

The study aimed to assess the success of a clinically indicated renal denervation by different tests and correlate the results of the tests with the clinical outcome.

Detailed description

We aim to test the response to adenosine infusion, cold pressure test, flow mediated dilation of renal artery before and after a clinical indicated renal denervation. Renal Denervation is not a study intervention

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

Male and female patients 18 years to 85 years of age, with a diagnosis of re-sistant hypertension (office sitting blood pressure \>140/90 mmHg and 24-hour blood pressure \>130/80 mmHg in patients treated with at least three antihypertensive drugs including a diuretic) and a clinical indication for a renal denervation.

Exclusion criteria

* Secondary cause of hypertension * Anatomical contraindication to renal denervation (renal artery diameter less than 4 mm or more than 8 mm), multiple renal artery, length to bifurcation less than 2 cm * Heart failure (normal ejection fractions on echocardiography and no clinical signs and symptoms of heart failure). * Alcohol or drug abuse, * Malignancy (unless healed or remission \> 5 years) * Pregnancy * Know allergy to contrast medium * Participation in another study within the last month

Design outcomes

Primary

Measure	Time frame	Description
Response to adenosine infusion, cold pressure test, flow mediated dilation of renal artery before and 1 year after renal denervation B	chronic	Changes in blood pressure and heart rate, in renal artery diameter and flow during adenosine infusion before and 1 year after renal denervation
lood pressure (office and 24-hour blood pressure), laboratory parameter before and 12 months after catheter-based renal denrevation	chronic	—

Secondary

Measure	Time frame	Description
Blood pressure (office and 24-hour blood pressure), laboratory parameter before and 1, 3, 6 months after catheter-based	chronic	Blood pressure (office and 24-hour blood pressure), laboratory parameter before and 1, 3, 6 months after catheter-based

Countries

Switzerland

Outcome results