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Renal Denervation in Patients With Chronic Heart Failure and Resynchronization Therapy

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: NCT02329145
Recruitment Status : Unknown
Verified December 2014 by Aleksander Kusiak, Jagiellonian University.
Recruitment status was:  Recruiting
First Posted : December 31, 2014
Last Update Posted : December 31, 2014
Sponsor:
Information provided by (Responsible Party):
Aleksander Kusiak, Jagiellonian University

Brief Summary:
Chronic heart failure is becoming more and more common disease and activation of sympathetic nervous system plays a crucial role in its development. There is some data allowing to suspect that one of the new treatment methods- renal denervation, also in patients with chronic heart failure may lead to decrease of systemic activity sympathetic nervous system and, as a consequence, to decrease of disease progression. The research hypothesis is whether renal denervation in case of symptomatic heart failure, even the optimal treatment therapy is used (including resynchronization therapy), is contributing to the improvement in parameters of neurohormonal activation, hemodynamics and clinical patient status. The aim of the study is to obtain a new knowledge concerning renal denervation in chronic heart failure, So far only very limited data- mostly case reports- are available in this study area.

Condition or disease Intervention/treatment Phase
Heart Failure Procedure: renal denervation Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Renal Denervation in Patients With Chronic Heart Failure and Resynchronization Therapy
Study Start Date : July 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Active treatment
Renal denervation
Procedure: renal denervation
No Intervention: Observational



Primary Outcome Measures :
  1. Number of hospitalizations due to heart failure worsening. [ Time Frame: one year ]
  2. Change in NYHA class. [ Time Frame: one year ]
  3. Change in 6 minute walk test distance. [ Time Frame: one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. age ≥ 18 year
  2. heart failure patients NYHA Class II - IV
  3. implanted resynchronization pacemaker according to current european guidelines at least 6 months earlier
  4. symptoms of heart failure even on optimal pharmacological therapy including resynchronization therapy (lack of improvement within dyspnoea and exercise tolerance after the procedure)
  5. left ventricular ejection function ≤ 35%
  6. glomerular filtration rate (eGFR according to MDRD formula ≥ 30 mL/min/1.73m2)
  7. patient informed consent for participation in the study

Exclusion Criteria:

  1. renal artery anatomy not eligible for denervation (at least 4 mm diameter, 20 mm in length)
  2. history of prior renal artery intervention
  3. single functioning kidney
  4. clinic systolic BP < 110mmHg
  5. pregnancy
  6. acute coronary syndrome or cerebrovascular event within last 3 months
  7. serious medical conditions which may adversely affect safety- clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders (thrombocytopenia, hemophilia, or significant anemia)

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): NCT02329145


Contacts
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Contact: Aleksander Kusiak, PhD,MD +48124247300 alek.kusiak@gmail.com

Locations
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Poland
Ist Department of Cardiology, Interventional Electrocardiology and Hypertension Recruiting
Krakow, Malopolska, Poland, 31-501
Contact: Aleksander Kusiak, MD, PHD    +48124247300    alek.kusiak@gmail.com   
Sponsors and Collaborators
Jagiellonian University
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Responsible Party: Aleksander Kusiak, MD, PhD, Jagiellonian University
ClinicalTrials.gov Identifier: NCT02329145    
Other Study ID Numbers: 204069
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: December 31, 2014
Last Verified: December 2014
Keywords provided by Aleksander Kusiak, Jagiellonian University:
renal denervation
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases