Renal Sympathetic Denervation in Mild Refractory Hypertension

NCT01656096 | Completed Phase 4

• 1 other identifier: RSD-Leipzig
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the benefit of renal sympathetic denervation in patients with mild refractory hypertension

Conditions

Refractory Hypertension

Outcome Measures

Primary Outcomes (1)

• Change in systolic blood pressure (ABPM mean value)

  6 months

Study Arms (2)

Renal sympathetic denervation

EXPERIMENTAL

Renal sympathetic denervation (Symplicity ablation catheter, Medtronic Inc. Minneapolis, Minnesota, USA)

Device: Renal sympathetic denervation (Symplicity ablation catheter, Medtronic Inc. Minneapolis, Minnesota, USA)

Sham procedure

SHAM COMPARATOR

Sham procedure mimicking the renal sympathetic denervation procedure in the experimental arm

Other: Sham procedure

Interventions

Renal sympathetic denervation (Symplicity ablation catheter, Medtronic Inc. Minneapolis, Minnesota, USA) DEVICE

Renal sympathetic denervation

Sham procedure OTHER

Sham procedure

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Refractory hypertension: 3 or more antihypertensive agents of different classes (including a diuretic) at optimal dosage without change in the 4 weeks preceding randomization
• Systolic blood pressure of 135-149 and/or diastolic blood pressure of 90-94 mmHg (ABPM mean daytime values)
• No change in blood pressure medication within 6 months after randomization
• Age 18 to 75 years
• Informed consent

You may not qualify if:

• Blood pressure outside range mentioned above
• Renal, aortic or pelvic anatomy unsuited for renal sympathetic denervation
• Estimated glomerular filtration rate \<45 mL/min/1.73 m² (modification of diet in renal disease formula)
• Unstable angina pectoris
• Myocardial infarction within 6 months prior to randomization
• Planned surgery or cardiovascular intervention within 6 months after randomization
• Severe heart valve disease
• Severe comorbidities with limited life expectancy
• Pregnancy
• Participation in another trial

Sponsors & Collaborators

• University of Leipzig: lead

Study Sites (1)

University of Leipzig Heart Center

Leipzig, 04289, Germany

Location

Related Publications (1)

• Desch S, Okon T, Heinemann D, Kulle K, Rohnert K, Sonnabend M, Petzold M, Muller U, Schuler G, Eitel I, Thiele H, Lurz P. Randomized sham-controlled trial of renal sympathetic denervation in mild resistant hypertension. Hypertension. 2015 Jun;65(6):1202-8. doi: 10.1161/HYPERTENSIONAHA.115.05283. Epub 2015 Mar 30.

  PMID: 25824248 DERIVED

Related Links

• Publication of study

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Steffen Desch, MD

  Heart Center Leipzig - University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 31, 2012
• First Posted: August 2, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: October 28, 2016

Record last verified: 2016-10

Locations

DE (1)