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Renal Denervation in Patients With Heart Failure With Normal LV Ejection Fraction

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: NCT02115230
Recruitment Status : Unknown
Verified April 2014 by Pedro A. Lemos, InCor Heart Institute.
Recruitment status was:  Recruiting
First Posted : April 15, 2014
Last Update Posted : April 15, 2014
Sponsor:
Information provided by (Responsible Party):
Pedro A. Lemos, InCor Heart Institute

Brief Summary:
It is a randomized prospective controlled study of transcatheter renal denervation in patients with Heart Failure With Normal LV Ejection Fraction. The purpose of the study is to evaluate the safety and effectiveness of renal denervation in patients with Heart Failure With Normal LV Ejection Fraction, due to reduction in renal and systemic sympathetic activity.

Condition or disease Intervention/treatment Phase
Heart Failure, Diastolic Hypertension Procedure: Renal denervation + medical therapy Not Applicable

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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: Transcatheter Renal Denervation in Heart Failure With Normal Left Ventricular Ejection Fraction - a Safety and Efficacy Study of Irrigated Radiofrequency Catheter
Study Start Date : April 2014
Estimated Primary Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Renal denervation + medical therapy
Renal sympathetic denervation with an irrigated radiofrequency catheter with Celsius Thermocool (Biosense Webster, California, USA) + standard optimized medical therapy for diastolic heart failure
Procedure: Renal denervation + medical therapy
Renal denervation + medical therapy Renal sympathetic denervation with an irrigated radiofrequency catheter with Celsius Thermocool (Biosense Webster, California, USA) + standard optimized medical therapy for diastolic heart failure

No Intervention: Medical therapy
Standard optimized medical therapy for diastolic heart failure



Primary Outcome Measures :
  1. Efficacy: Change from baseline E/E' on echocardiography at 12 months [ Time Frame: 12 months after treatment ]
  2. Safety: Composite of death, myocardial infarction, cerebrovascular event, need of intervention on renal arteries and renal function impairment (decrease in estimated GFR > 30% from baseline) [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Change from baseline E/E' on echocardiography at 6 months [ Time Frame: 6 months ]
  2. Change of office blood pressure and ambulatory blood pressure monitoring (ABPM) between baseline and 12 months [ Time Frame: 12 months ]
  3. Change in any echocardiographic diastolic parameter between baseline and 12 months [ Time Frame: 12 months ]
  4. Change in 6 min walking distance between baseline and 12 months [ Time Frame: 12 months ]
  5. Change in quality of life (Minnesota Living with Heart Failure Questionnaire) between baseline and 12 months [ Time Frame: 12 months ]
  6. Change in serum B-type natriuretic peptide (BNP) between baseline and 12 months [ Time Frame: 12 months ]
  7. Change in peripheral sympathetic activity measured by microneurography between baseline and 12 months [ Time Frame: 12 months ]
  8. Change in non-invasive hemodynamic parameters provided by Finometer between baseline and 12 months [ Time Frame: 12 months ]
  9. Change in renal function (GFR, albuminury and 24h urinary Na excretion) between baseline and 12 months [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hypertension treated with at least 2 antihypertensive drugs;
  • Heart failure with a normal LV ejection fraction;
  • Left Ventricular Hypertrophy (LV mass index > 96 g/m2 in women and > 116 g/m2 in men);
  • ≥ 18 years of age;

Exclusion Criteria:

  • Known secondary cause of hypertension
  • Uncontrolled blood pressure (≥ 180x110mmHg)
  • Unsuitable anatomy of renal arteries, renal stenosis or previous treatment with balloon or stent
  • Advanced renal insufficiency (estimated glomerular filtration rate (GFR) < 30 ml/min/1.73 square meters)
  • Diabetes Mellitus type 1
  • Acute coronary syndrome or a cerebrovascular accident in the last 6 months
  • Known other cause of respiratory dysfunction
  • Previous LV systolic dysfunction (LVEF < 50%)
  • Restrictive cardiomyopathy or Hypertrophic cardiomyopathy
  • Significant valvar dysfunction
  • Atrial flutter or atrial fibrillation
  • Use of the oral anticoagulants
  • Drug and Alcohol dependence

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): NCT02115230


Locations
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Brazil
Heart Institute - InCor. University of Sao Paulo Medical School Recruiting
São Paulo, SP, Brazil, 05403-000
Contact: Patricia Pereira    +55 11 2661-5368    patricia.pereira@incor.usp.br   
Principal Investigator: Pedro Lemos, MD PhD         
Sponsors and Collaborators
InCor Heart Institute
Investigators
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Study Chair: Pedro A Lemos, MD PhD Heart Institute - InCor. University of Sao Paulo Medical School
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Responsible Party: Pedro A. Lemos, Pedro A. Lemos, Professor of Medicine, InCor Heart Institute, InCor Heart Institute
ClinicalTrials.gov Identifier: NCT02115230    
Other Study ID Numbers: IncorRDN-ICFEN
First Posted: April 15, 2014    Key Record Dates
Last Update Posted: April 15, 2014
Last Verified: April 2014
Keywords provided by Pedro A. Lemos, InCor Heart Institute:
Heart Failure
Heart Failure, Diastolic
Hypertension
Renal Denervation
Irrigated Radiofrequency Catheter
Additional relevant MeSH terms:
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Hypertension
Heart Failure
Heart Failure, Diastolic
Vascular Diseases
Cardiovascular Diseases
Heart Diseases