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Renal Denervation in Patients With Advanced Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01538992
Recruitment Status : Withdrawn (we could not fined enough patients for the study)
First Posted : February 27, 2012
Last Update Posted : July 24, 2013
Sponsor:
Information provided by (Responsible Party):
Hasan ARI, Bursa Postgraduate Hospital

Brief Summary:
Sympathetic system has important role occurrence of symptoms in heart failure. Renal denervation that is ablated some of sympathetic nerves is affected pathology of heart failure. This interventional therapy improves symptoms and life quality.

Condition or disease Intervention/treatment Phase
Heart Failure Device: Standard steerable Marinr RF ablation Catheter (5F or 7F) Phase 3

Detailed Description:

Primary Outcome Measures:

• Safety of Renal Denervation in Heart Failure patients as measured by Adverse Events

Secondary Outcome Measures:

• Ventricular function,NYHA functional Class, 6 min walking test, biochemical test and Renal function as measured by Glomerular Filtration Rate (GFR)

Eligibility Patients population: Volunteers, NYHA Class III-IV heart failure patients. Ages Eligible for Study: 18 Years to 85 Years Genders Eligible for Study: Both Accepts Healthy Volunteers: No


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 3 Study of Renal Denervation That Improves Symptoms of Heart Failure and Enhances Life Quality in Advanced Heart Failure
Study Start Date : April 2013
Estimated Primary Completion Date : January 2014
Estimated Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arm Intervention/treatment
Experimental: renal denervation
in this group percutaneous renal denervation with Standard steerable Mariner Radiofreqency ablation Catheter (5F or 7F)
Device: Standard steerable Marinr RF ablation Catheter (5F or 7F)
Intervention: Device: Standard steerable Mariner Radiofrequency ablation Catheter (5F or 7F)
Other Name: Renal ablation
No Intervention: medical thrapy
medical treatment



Primary Outcome Measures :
  1. Safety of Renal Denervation in Heart Failure patients as measured by Adverse Events [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. • Ventricular function as measured by Echocardiography • NYHA functional Class, 6 min walking test, biochemical test. • Renal function as measured by Glomerular Filtration Rate (GFR) [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Heart Failure patients NYHA Class III or IV
  • Left Ventricular Ejection Function < 35%
  • GFR > 45 mL/min/1.73m2
  • Optimal stable medical therapy

Exclusion Criteria:

  • Do not eligible renal artery anatomy for treatment as determined by Angiography, and
  • History of prior renal artery intervention
  • Single functioning kidney.
  • Myocardial Infarction, unstable angina pectoris or cerebrovascular Accident within 3 months
  • Systolic BP < 110mmHG Hospitalisation because of heart failure in last 3 weeks.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01538992


Locations
Turkey
Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi
Bursa, Turkey
Sponsors and Collaborators
Bursa Postgraduate Hospital
Investigators
Study Director: HASAN ARI, MD Bursa Postgraduate Hospital

Responsible Party: Hasan ARI, Medical Doctor, Cardiology Chief Intern, Bursa Postgraduate Hospital
ClinicalTrials.gov Identifier: NCT01538992     History of Changes
Other Study ID Numbers: Bursa YİEAH
First Posted: February 27, 2012    Key Record Dates
Last Update Posted: July 24, 2013
Last Verified: July 2013

Keywords provided by Hasan ARI, Bursa Postgraduate Hospital:
renal denervation
heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases