Metabolic and Cardiovascular Effects of Renal Denervation

Hypertension Clinical Trial

Official title:

Metabolic and Cardiovascular Effects of Renal Denervation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02057224
• Other study ID #: joan2014
• Status: Terminated
• Phase: N/A
• Start date: January 2014
• Est. completion date: October 22, 2018

Study information

• Verified date: August 2019
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Renal denervation has recently shown to improve glucose metabolism and insulin sensitivity in addition to reducing blood pressure. The mechanisms are however unclear. The investigators hypothesize that renal denervation alters adipose tissue function by reduced sympathetic outflow, measured by fat biopsies and markers of inflammation and insulin sensitivity. 15 clinical patients undergoing renal denervation are recruited to the study investigating anthropometry, peripheral blood samples, body composition, heart rate variability and subcutaneous fat biopsies at baseline and 6 months after renal denervation.

Description:

Renal denervation, a catheter-based approach to reduce renal sympathetic afferent and efferent activity has been used successfully to treat drug-resistant hypertension. Previous studies has demonstrated a reduction of muscle sympathetic nerve activity and renal and total body noradrenaline spillover. In addition, renal denervation seems to improve glucose metabolism and insulin sensitivity, representing the first potential nonpharmaceutical approach for treating insulin resistance. However, the mechanisms are unclear. There is a clear relationship between sympathetic overactivity and insulin resistance. Activation of the sympathetic nervous systems contributes to insulin resistance and metabolic disorders and insulin itself induces sympathetic overactivity. One possible explanation to improved glucose metabolism after renal denervation is altered adipose tissue function (due to the reduction in sympathetic activity). Therefore,15 individuals undergoing renal denervation are recruited. The clinical study includes anthropometry, peripheral blood samples, body composition, heart rate variability and subcutaneous fat biopsies before renal denervation and after 6 months.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: October 22, 2018
• Est. primary completion date: October 22, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Essential hypertension

• Systolic blood pressure >160 mm Hg despite =3 antihypertensive drugs

• Clinical patients accepted for renal denervation

Exclusion Criteria:

• Type 1 diabetes

• Pregnancy

• Glomerular filtration rate =45 ml/min/1,73 m2

• Pacemaker/ICD

• Myocardial infarction/stroke the last 12 months

Related Conditions & MeSH terms

• Hypertension
• Insulin Resistance

Intervention

Procedure:
• Renal denervation using Medtronic Symplicity System (mono-electrode)
Secondary hypertension is excluded by an extensive preoperative clinical investigation and the renal artery anatomy is visualized by computer tomography (with contrast). By cannulating the femoral artery both renal arteries are treated by a radiofrequency-catheter, 4-6 ablations in each artery.

Locations

Country	Name	City	State
Sweden	Umeå University	Umeå

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adipose tissue function	Fat biopsies	6 months after renal denervation
Secondary	Heart rate variability		6 months after renal denervation
Secondary	Body composition	Measured by DXA	6 months after renal denervation