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Status unknownNCT01785732RENSYMPISUpdated Feb 11, 2013

Renal Sympathetic Denervation and Insulin Sensitivity (RENSYMPIS Study)

An interventional study of Renal Denervation in Resistant Hypertension, sponsored by The Hospital District of Satakunta. Status unknown at 1 site in Finland. Open to participants aged 30 Years to 69 Years. Per ClinicalTrials.gov, last updated 2013-02-11.

Sponsored by The Hospital District of Satakunta · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
30 Years to 69 Years
Sex
All
01

Study summary

Hypertension is a major risk factor for stroke and cardiovascular mortality. Catheter- based renal denervation causes substantial and sustained blood- pressure reduction in patients with resistant hypertension.

The purpose of RENSYMPIS is to study the effects of renal denervation on:

  1. Cardiovascular function
  2. Metabolic factors
  3. Inflammatory and endocrine factors
  4. Coagulation
  5. Sleep
02

Conditions studied

  • Resistant Hypertension

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03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's planned enrollment of 60 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

The Hospital District of Satakunta is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 69 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Resistant Hypertension (systolic blood pressure >160mmHg and 3 or more antihypertensive agents in use)
  • Age 30- 69 years
  • Written informed consent

Exclusion criteria

Exclusion Criteria:

  • Secondary hypertension
  • Pseudohypertension
  • Pregnancy
  • Renal insufficiency (GFR \<45ml/min)
  • Clinically significant stenotic valvular disease
  • Oral anticoagulation
  • CCS III-IV symptoms or CABG/PCI in previous 6 months
  • Prior stroke
  • Contrast agent allergy
  • inappropriate renal artery anatomy (\< 4mm diameter, \< 20mm length)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Renal denervation

    Patients are randomized to renal denervation

    Procedure: Renal Denervation

  • No intervention
    Optimization of medical therapy

    Antihypertensive treatment is optimized

Interventions

  • ProcedureRenal Denervation

    Sympathetic renal denervation via renal arteries

06

What researchers measure

Primary outcomes

  1. Office blood pressure

    Time frame: 2 years

Secondary outcomes

  1. Ambulatory blood pressure

    Time frame: 2 years

  2. Insulin resistance

    Time frame: 2 years

  3. Endothelial function

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • Satakunta Central Hospital
    Pori, Finland
    • Tuomas Paana, M.D · Contact · tuomas.paana@satshp.fi · +358 2 6277100
    • Tuomas Paana, M.D. · Principal investigator
    • Antti Ylitalo, M.D. Ph.D · Principal investigator
    • Risto Kaaja, M.D. Ph.D. · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01785732
Lead sponsor
The Hospital District of Satakunta
Responsible party
Sponsor
First posted
Feb 7, 2013
Start date
Jan 2013
Primary completion
Jan 2014 (estimated)
Completion
Jan 2016 (estimated)
Last update
Feb 11, 2013

Study contacts

Tuomas Paana, M.D.
Contact
tuomas.paana@satshp.fi
+358 2 6277100
Antti Ylitalo, M.D. Ph.D
Contact
antti.ylitalo@satshp.fi
+358 2 6277100

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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Discussion

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