Clinical trial NCT02115230: Renal Denervation in Patients With Heart Failure With Normal LV Ejection Fraction
Official title: Transcatheter Renal Denervation in Heart Failure With Normal Left Ventricular Ejection Fraction - a Safety and Efficacy Study of Irrigated Radiofrequency Catheter
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure, Diastolic
Hypertension
Keywords: Heart Failure
Heart Failure, Diastolic
Hypertension
Renal Denervation
Irrigated Radiofrequency Catheter
Lead sponsor: InCor Heart Institute
Sponsor class: OTHER
First posted: 2014-04-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Efficacy: Change from baseline E/E' on echocardiography at 12 months
timeFrame: 12 months after treatment
measure: 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)
timeFrame: 12 months
Secondary outcomes:
measure: Change from baseline E/E' on echocardiography at 6 months
timeFrame: 6 months
measure: Change of office blood pressure and ambulatory blood pressure monitoring (ABPM) between baseline and 12 months
timeFrame: 12 months
measure: Change in any echocardiographic diastolic parameter between baseline and 12 months
timeFrame: 12 months
measure: Change in 6 min walking distance between baseline and 12 months
timeFrame: 12 months
measure: Change in quality of life (Minnesota Living with Heart Failure Questionnaire) between baseline and 12 months
timeFrame: 12 months
measure: Change in serum B-type natriuretic peptide (BNP) between baseline and 12 months
timeFrame: 12 months
measure: Change in peripheral sympathetic activity measured by microneurography between baseline and 12 months
timeFrame: 12 months
measure: Change in non-invasive hemodynamic parameters provided by Finometer between baseline and 12 months
timeFrame: 12 months
measure: Change in renal function (GFR, albuminury and 24h urinary Na excretion) between baseline and 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Heart Institute - InCor. University of Sao Paulo Medical School
state: SP
Study officials:
affiliation: Heart Institute - InCor. University of Sao Paulo Medical School
name: Pedro A Lemos, MD PhD
role: STUDY_CHAIR
References: