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Renal Sympathetic Denervation in Mild Refractory Hypertension

NCT ID: NCT01656096

Last Updated: 2016-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-07-31

Brief Summary

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

Detailed Description

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Conditions

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Refractory Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Renal sympathetic denervation

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

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

Sham procedure

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

Group Type SHAM_COMPARATOR

Sham procedure

Intervention Type OTHER

Interventions

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

Intervention Type DEVICE

Sham procedure

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Leipzig

OTHER

Sponsor Role lead

Responsible Party

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Steffen Desch, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Steffen Desch, MD

Role: PRINCIPAL_INVESTIGATOR

Heart Center Leipzig - University Hospital

Locations

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University of Leipzig Heart Center

Leipzig, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 25824248 (View on PubMed)

Related Links

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http://www.ncbi.nlm.nih.gov/pubmed/25824248

Publication of study

Other Identifiers

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RSD-Leipzig

Identifier Type: -

Identifier Source: org_study_id