NCT02115230

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 15, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Last Updated

April 15, 2014

Status Verified

April 1, 2014

Enrollment Period

2.3 years

First QC Date

April 13, 2014

Last Update Submit

April 13, 2014

Conditions

Heart Failure, DiastolicHypertension

Keywords

Heart FailureHeart Failure, DiastolicHypertensionRenal DenervationIrrigated Radiofrequency Catheter

Outcome Measures

Primary Outcomes (2)

  • Efficacy: Change from baseline E/E' on echocardiography at 12 months

    12 months after treatment

  • 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

Secondary Outcomes (9)

  • Change from baseline E/E' on echocardiography at 6 months

    6 months

  • Change of office blood pressure and ambulatory blood pressure monitoring (ABPM) between baseline and 12 months

    12 months

  • Change in any echocardiographic diastolic parameter between baseline and 12 months

    12 months

  • Change in 6 min walking distance between baseline and 12 months

    12 months

  • Change in quality of life (Minnesota Living with Heart Failure Questionnaire) between baseline and 12 months

    12 months

  • +4 more secondary outcomes

Study Arms (2)

Renal denervation + medical therapy

EXPERIMENTAL

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

Medical therapy

NO INTERVENTION

Standard optimized medical therapy for diastolic heart failure

Interventions

Renal denervation + medical therapyPROCEDURE

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

Renal denervation + medical therapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart Institute - InCor. University of Sao Paulo Medical School

São Paulo, São Paulo, 05403-000, Brazil

RECRUITING

MeSH Terms

Conditions

Heart Failure, DiastolicHypertensionHeart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Pedro A Lemos, MD PhD

    Heart Institute - InCor. University of Sao Paulo Medical School

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pedro A. Lemos, Professor of Medicine, InCor Heart Institute

Study Record Dates

First Submitted

April 13, 2014

First Posted

April 15, 2014

Study Start

April 1, 2014

Primary Completion

July 1, 2016

Last Updated

April 15, 2014

Record last verified: 2014-04

Locations

BR(1)