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Renal Denervation in Patients With Advanced Heart Failure

This study has been withdrawn prior to enrollment.
(we could not fined enough patients for the study)
Sponsor:
Information provided by (Responsible Party):
Hasan ARI, Bursa Postgraduate Hospital
ClinicalTrials.gov Identifier:
NCT01538992
First received: February 16, 2012
Last updated: July 23, 2013
Last verified: July 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Bursa Postgraduate Hospital:

Primary Outcome Measures:
  • Safety of Renal Denervation in Heart Failure patients as measured by Adverse Events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: April 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: February 16, 2012
Last Updated: July 23, 2013
Health Authority: Turkey: Ethics Committee

Keywords provided by Bursa Postgraduate Hospital:
renal denervation
heart failure

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 25, 2014