Clinical trial NCT01888315: Influence of Catheter-based Renal Denervation in Diseases With Increased Sympathetic Activity
Official title: Safety and Efficacy Study Investigating the Effects of Catheter-based Renal Denervation on Different Organ Systems in Patients With Increased Sympathetic Activity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Hypertension
Heart Failure
Chronic Kidney Disease
Diabetes
Heart Rhythm Disorders
Keywords: Hypertension
Heart Failure
Sympathetic activity
Lead sponsor: University Hospital, Saarland
Sponsor class: OTHER
First posted: 2013-06-27
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.).

Eligibility criteria: 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.).

Primary outcomes:
measure: Safety and efficacy of renal denervation
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Effect of renal denervation on different organ systems.
timeFrame: Baseline, 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
measure: Safety and efficacy of renal denervation
timeFrame: Baseline, 3, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
Other outcomes:
Locations:
city: Homburg/Saar
country: Germany
facility: University Hospital Saarland
Study officials:
affiliation: University Hospital, Saarland
name: Felix Mahfoud, MD
role: STUDY_DIRECTOR
affiliation: University Hospital, Saarland
name: Michael Böhm, MD
role: PRINCIPAL_INVESTIGATOR
References: