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

Hypertension Clinical Trial

Official title:

Transcatheter Renal Denervation in Heart Failure With Normal Left Ventricular Ejection Fraction - a Safety and Efficacy Study of Irrigated Radiofrequency Catheter

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02115230
• Other study ID #: IncorRDN-ICFEN
• Status: Recruiting
• Phase: N/A
• First received: April 13, 2014
• Last updated: April 13, 2014
• Start date: April 2014

Study information

• Verified date: April 2014
• Source: InCor Heart Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeBrazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Diastolic
• Hypertension

Intervention

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

Locations

Country	Name	City	State
Brazil	Heart Institute - InCor. University of Sao Paulo Medical School	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
InCor Heart Institute

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: Change from baseline E/E' on echocardiography at 12 months		12 months after treatment	No
Primary	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)		12 months	Yes
Secondary	Change from baseline E/E' on echocardiography at 6 months		6 months	No
Secondary	Change of office blood pressure and ambulatory blood pressure monitoring (ABPM) between baseline and 12 months		12 months	No
Secondary	Change in any echocardiographic diastolic parameter between baseline and 12 months		12 months	No
Secondary	Change in 6 min walking distance between baseline and 12 months		12 months	No
Secondary	Change in quality of life (Minnesota Living with Heart Failure Questionnaire) between baseline and 12 months		12 months	No
Secondary	Change in serum B-type natriuretic peptide (BNP) between baseline and 12 months		12 months	No
Secondary	Change in peripheral sympathetic activity measured by microneurography between baseline and 12 months		12 months	No
Secondary	Change in non-invasive hemodynamic parameters provided by Finometer between baseline and 12 months		12 months	No
Secondary	Change in renal function (GFR, albuminury and 24h urinary Na excretion) between baseline and 12 months		12 months	Yes