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Supportive Treatment of Severe Heart Failure by Renal Denervation (Heart-RND)

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: NCT02638324
Recruitment Status : Unknown
Verified December 2015 by Turku University Hospital.
Recruitment status was:  Recruiting
First Posted : December 23, 2015
Last Update Posted : December 23, 2015
Sponsor:
Collaborator:
Satakunta Central Hospital
Information provided by (Responsible Party):
Turku University Hospital

Brief Summary:
The overactivity of sympathetic nervous system is worsening the hemodynamic state of heart failure patients. The present study is planned to reduce the sympathetic tone in patients with severe heart failure by renal nervous denervation.

Condition or disease Intervention/treatment Phase
Heart Failure Device: Renal nervous denervation Not Applicable

Detailed Description:
The patient population consists of heart failure patients who are not responding properly to medication and biventricular pacing therapy. The inappropriate response to these therapies is evaluated by patient history (NYHA III-IV), echocardiography (EF < 45%), 6-minute walk test (<440m) and measurements of P-ProBNP. The patients who fulfill the inclusion criteria will undergo renal nervous denervation. The patients will be followed up with the same methods as they were recruited to the study. The overall time of follow-up will be 24 months. The patients are randomised according to the waiting list principle in a manner to 1:1. The waiting time will be 6 months.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Supportive Treatment of Severe Heart Failure by Renal Denervation
Study Start Date : December 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Active Comparator: Renal nervous denervation.
Renal nervous denervation is performed to the patients who do not response properly to conventional therapy. The patients are randomised according to the waiting list principle.
Device: Renal nervous denervation
The heart failure patients will undergo renal nervous denervation if they have not properly responded to medication and biventricular pacing therapy.

Active Comparator: Renal nervous denervation (delayed)
Renal nervous denervation is performed after six months on the waiting list
Device: Renal nervous denervation
The heart failure patients will undergo renal nervous denervation if they have not properly responded to medication and biventricular pacing therapy.




Primary Outcome Measures :
  1. 6-minute walking test [ Time Frame: 24 months ]
    Composite outcome measure


Secondary Outcome Measures :
  1. Patient history [ Time Frame: 24 months ]
    Composite outcome measure

  2. Cardiac echocardiography [ Time Frame: 24 months ]
    Composite outcome measure

  3. P-proBNP [ Time Frame: 24 months ]
    Composite outcome measure



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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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:

  • NYHA III-IV
  • ejection fraction <45 %
  • 6-minute walking test under 440m

Exclusion Criteria:

  • Unstable hemodynamic state
  • uncooperation

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): NCT02638324


Contacts
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Contact: Juhani Koistinen, MD +35863231111 juhani.koistinen@vshp.fi
Contact: Hirvioja Alpo, MD +35862131111

Locations
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Finland
Vaasa Central Hospital Recruiting
Vaasa, Finland, 65130
Contact: Juhani Koistinen, MD    +35863231111    juhani.koistinen@vshp.fi   
Contact: Päivi Pietilä-Effati, MD    +35863231111    paivi.pietila-effati@vshp.fi   
Principal Investigator: Juhani Koistinen, MD         
Sub-Investigator: Päivi Pietilä-Effati, MD         
Sponsors and Collaborators
Turku University Hospital
Satakunta Central Hospital
Investigators
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Study Chair: Mari-Anne Vaittinen, MD Vaasa Central Hospitla
Study Chair: Mari-Anne Vaittinen, MD Vaasa Central Hospital, Vaasa, Finland
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Responsible Party: Turku University Hospital
ClinicalTrials.gov Identifier: NCT02638324    
Other Study ID Numbers: Juhani02
First Posted: December 23, 2015    Key Record Dates
Last Update Posted: December 23, 2015
Last Verified: December 2015
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases