NCT01785732

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 5, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 7, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

February 11, 2013

Status Verified

February 1, 2013

Enrollment Period

1 year

First QC Date

February 5, 2013

Last Update Submit

February 8, 2013

Conditions

Resistant Hypertension

Outcome Measures

Primary Outcomes (1)

  • Office blood pressure

    2 years

Secondary Outcomes (3)

  • Ambulatory blood pressure

    2 years

  • Insulin resistance

    2 years

  • Endothelial function

    2 years

Study Arms (2)

Renal denervation

ACTIVE COMPARATOR

Patients are randomized to renal denervation

Procedure: Renal Denervation

Optimization of medical therapy

NO INTERVENTION

Antihypertensive treatment is optimized

Interventions

Renal DenervationPROCEDURE

Sympathetic renal denervation via renal arteries

Renal denervation

Eligibility Criteria

Age30 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Satakunta Central Hospital

Pori, Finland

RECRUITING

Central Study Contacts

Tuomas Paana, M.D.

CONTACT

+358 2 6277100tuomas.paana@satshp.fi

Antti Ylitalo, M.D. Ph.D

CONTACT

+358 2 6277100antti.ylitalo@satshp.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2013

First Posted

February 7, 2013

Study Start

January 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2016

Last Updated

February 11, 2013

Record last verified: 2013-02

Locations

FI(1)