Sympathetic Activity and Renal Denervation

Hypertension Clinical Trial

— ReD  

Official title:

Influences of Catheter-based Renal Denervation on Central Sympathetic Nervous System Regulation in Refractory Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01355055
• Other study ID #: DE-MHH-ReD-EK5853
• Status: Recruiting
• Phase: N/A
• First received: May 16, 2011
• Last updated: May 16, 2011
• Start date: March 2011

Study information

• Verified date: March 2011
• Source: Hannover Medical School
• Contact: Heusser Karsten, MD
• Phone: +495115322723
• Email: heusser.karsten[@]mh-hannover.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

Primary hypothesis:

Catheter-based renal denervation reduces central sympathetic activation in patients with refractory hypertension.

Secondary hypotheses:

1. The magnitude of the individual depressor response after catheter-based renal denervation depends on the extent of sympathoinhibition.

2. Both, the reduction in arterial pressure and in central sympathetic activation are sustained over time up to 24±3 months after catheter-based renal denervation.

3. Catheter-based renal denervation resets the sympathetic baroreflex to lower blood pressure values.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Refractory hypertension (as defined by the WHO: poorly controlled hypertension (>140/90 mmHg) despite adequate doses of at least three antihypertensive drugs including a diuretic)

• Men or women aged >18 years

• Intact peroneal nerve

• Written informed consent

Exclusion Criteria:

• Diseases, dysfunctions, or medications (such as NET inhibitors) that exclude a participation in the study according to the investigator.

• Legal incompetence or circumstances that interfere with the patient´s ability to fully understand scope, relevance, and/or consequences of participation in this study.

• People in custody

• hypersensitivity to clonidine, phenylephrine, or nitroprusside-sodium

• sick sinus syndrome, second or third degree AV block, bradycardia < 50 bpm (contraindication for clonidine)

• endogenous depression (contraindication for clonidine)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypertension

Locations

Country	Name	City	State
Germany	Hannover Medical School	Hannover

Sponsors (1)

Lead Sponsor	Collaborator
Hannover Medical School

Country where clinical trial is conducted

Germany,