Status:
UNKNOWN
Renal Denervation in Patients With Heart Failure and Severe Left Ventricular Dysfunction.
Lead Sponsor:
University Hospital Olomouc
Conditions:
Heart Failure
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
It is a randomized prospective controlled study evaluating the effect of transcatheter renal denervation on the clinical status of patients with chronic heart failure and its safety procedures. The wo...
Detailed Description
Chronic heart failure in the European countries occurs in 2-3% of the population with a significant increase in the higher age groups (1). Improved treatment of acute conditions (especially myocardial...
Eligibility Criteria
Inclusion
- Patients over 18 years of age with chronic heart failure, ischemic and non-ischemic etiology.
- NYHA (New York Heart Association) class II-IV.
- LVEF (Left Ventricular Ejection Fraction) ≤ 35%.
- Patients treated with maximum tolerated doses of standard pharmacotherapy for heart failure, who were stable for at least four weeks without acute decompensated heart failure.
- Prior to enrollment, patients must give informed consent.
Exclusion
- Patients with history of acute coronary syndrome or stroke within the last 6 months.
- Significant valvular defects and/or planned cardiac surgery.
- Systolic blood pressure \<110 mmHg.
- Advanced renal insufficiency (estimated GFR (Glomerular Filtration Rate) according to MDRD \<30 ml/min/1.73 square meters).
- Unsuitable anatomy of renal arteries (presence of significant renal stenosis, renal artery narrower than 4 mm).
- Patients who underwent renal angioplasty or stent placement into the renal artery in the past.
- Severe coagulation disorders.
- Pregnancy or lactation.
- Refusal of the patient.
- Other diseases limiting prognosis of the patient to less than 2 years.
- Other reasons which in the opinion of the attending physician would preclude the individual from participating in the study.
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2016
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01870310
Start Date
June 1 2012
End Date
June 1 2016
Last Update
June 6 2013
Active Locations (1)
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1
University Hospital, Olomouc
Olomouc, Olomouc, Czechia, 775 20