Influence of Catheter-based Renal Denervation in Diseases With Increased Sympathetic Activity

Hypertension Clinical Trial

Official title:

Safety and Efficacy Study Investigating the Effects of Catheter-based Renal Denervation on Different Organ Systems in Patients With Increased Sympathetic Activity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01888315
• Other study ID #: Symplicity Extension
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: September 4, 2012
• Last updated: June 24, 2013
• Start date: January 2011
• Est. completion date: January 2021

Study information

• Verified date: June 2013
• Source: University Hospital, Saarland
• Contact: Felix Mahfoud, MD
• Phone: +4968411621346
• Email: felix.mahfoud[@]uks.eu
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

The study is aiming to document the long-term safety and effectiveness of renal denervation in patients with hypertension and other diseases characterized by elevated sympathetic drive. Catheter-based renal denervation will be performed using CE marked, percutaneous, systems.

Description:

Inclusion Criteria

1. Individual is 18 years of age.

2. Individual agrees to have all procedures performed, and is competent and willing to provide written, informed consent to participate in the registry.

3. Patient scheduled for renal sympathetic denervation using market-released device.

Exclusion Criteria

1. In the eyes of the treating physician, the renal artery anatomy would interfere with safe cannulation of the renal artery or meets local standards for surgical repair.

2. Individual has any serious medical condition, which in the opinion of the treating physician may adversely affect the safety and/or effectiveness of the participant (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, significant anemia, etc.).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: January 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

1. Individual is 18 years of age.

2. Individual agrees to have all procedures performed, and is competent and willing to provide written, informed consent to participate in the registry.

3. Patient scheduled for renal sympathetic denervation using market-released device.

Exclusion Criteria

1. In the eyes of the treating physician, the renal artery anatomy would interfere with safe cannulation of the renal artery or meets local standards for surgical repair.

2. Individual has any serious medical condition, which in the opinion of the treating physician may adversely affect the safety and/or effectiveness of the participant (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, significant anemia, etc.).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Chronic Kidney Disease
• Diabetes
• Heart Failure
• Heart Rhythm Disorders
• Hypertension
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Device:
• Renal denervation with Symplicity Flex Medtronic/Ardian
Renal denervation using CE-marked devices will be performed according to best medical practice.
• Renal denervation with EnligHTN St. Jude Medical
Renal denervation using CE-marked devices will be performed according to best medical practice.
• Renal denervation with Paradise Recor
Renal denervation using CE-marked devices will be performed according to best medical practice.
• Renal denervation with V2 Vessix
Renal denervation using CE-marked devices will be performed according to best medical practice.

Locations

Country	Name	City	State
Germany	University Hospital Saarland	Homburg/Saar

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Saarland

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and efficacy of renal denervation	Effect on blood pressure including office, ABPM, and home-based measurements.; Number of adverse events (death, stroke, myocardial infarction, new dialysis, and congestive heart failure).; Changes of antihypertensive medications.; Effects on renal function assessed with glomerular filtration rate.; Renovascular safety (renal artery stenosis) assessed by duplex ultrasound.	Baseline to 6 months	Yes
Secondary	Effect of renal denervation on different organ systems.	Myocardial function and geometry using echo and MRI.; Heart rate changes and arrhythmias.; Glucose metabolism and insulin resistance (fasting and during oGTT).; Hospitalization rates (eg. hypertensive emergencies, heart failure, etc).	Baseline, 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months	Yes
Secondary	Safety and efficacy of renal denervation	Effect on blood pressure including office, ABPM, and home-based measurements.; Number of adverse events (death, stroke, myocardial infarction, new dialysis, and congestive heart failure).; Changes of antihypertensive medications.; Effects on renal function assessed with glomerular filtration rate.; Renovascular safety (renal artery stenosis) assessed by duplex ultrasound.	Baseline, 3, 12, 18, 24, 30, 36, 42, 48, 54, 60 months	Yes