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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02329145 |
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Date of registration:
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23/12/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Renal Denervation in Patients With Chronic Heart Failure and Resynchronization Therapy
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Scientific title:
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Renal Denervation in Patients With Chronic Heart Failure and Resynchronization Therapy |
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Date of first enrolment:
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July 2013 |
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Target sample size:
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20 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02329145 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Poland
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Contacts
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Name:
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Aleksander Kusiak, PhD,MD |
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Address:
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Telephone:
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+48124247300 |
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Email:
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alek.kusiak@gmail.com |
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Affiliation:
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Name:
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Aleksander Kusiak, MD, PHD |
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Address:
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Telephone:
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+48124247300 |
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Email:
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alek.kusiak@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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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)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Heart Failure
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Intervention(s)
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Procedure: renal denervation
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Primary Outcome(s)
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Number of hospitalizations due to heart failure worsening.
[Time Frame: one year]
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Change in 6 minute walk test distance.
[Time Frame: one year]
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Change in NYHA class.
[Time Frame: one year]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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