NCT02099903

Brief Summary

It is a randomized prospective controlled study of transcatheter renal denervation in patients with systolic heart failure secondary to Chagas' disease. The purpose of the study is to evaluate the safety and effectiveness of renal denervation in patients with Chagas heart disease, due to reduction in renal and systemic sympathetic activity.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Mar 2014

Shorter than P25 for not_applicable heart-failure

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

March 1, 2014

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 31, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

March 31, 2014

Status Verified

March 1, 2014

Enrollment Period

9 months

First QC Date

March 19, 2014

Last Update Submit

March 26, 2014

Conditions

Heart FailureHeart Failure, SystolicChagas DiseaseChagas Cardiomyopathy

Keywords

Heart FailureHeart Failure, SystolicChagas DiseaseChagas CardiomyopathyRenal DenervationIrrigated Radiofrequency Catheter

Outcome Measures

Primary Outcomes (1)

  • Composite: death, myocardial infarction, cerebrovascular event, need of intervention on renal arteries and renal function impairment (decrease in estimated GFR > 30% from baseline).

    30 days.

Secondary Outcomes (4)

  • Left Ventricular Ejection Fraction (LVEF) by echocardiography.

    9 months.

  • New York Heart Association (NYHA) functional class.

    9 months.

  • 6-minute walk test

    9 months.

  • Peak Oxygen consumption (VO2) by ergoespirometry.

    9 months.

Other Outcomes (3)

  • Change in serum B-type natriuretic peptide (BNP).

    9 months.

  • Quality of life assessed by Minnesota and EuroQOL five dimensions (EQ-5D)questionnaires.

    9 months.

  • Peripheral sympathetic activity measured by microneurography.

    9 months.

Study Arms (2)

Medical therapy for heart failure

NO INTERVENTION

Standard optimized medical therapy for heart failure.

Renal denervation + medical therapy.

EXPERIMENTAL

Transcatheter Renal Denervation with irrigated radiofrequency catheter + standard medical therapy.

Device: transcatheter renal denervation

Interventions

transcatheter renal denervationDEVICE

Renal sympathetic denervation with an irrigated radiofrequency catheter.

Also known as: Celsius Thermocool (Biosense Webster, California, USA)
Renal denervation + medical therapy.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients ≥ 18 to ≤ 70 years of age with chronic systolic heart failure, Chagas disease etiology.
  • Two positive serology results for Chagas by two distinct methods.
  • NYHA (New York Heart Association) class II or III.
  • Patients treated with maximum tolerated doses of standard pharmacotherapy for heart failure.
  • LVEF (Left Ventricular Ejection Fraction) ≤ 40% (Simpson Method).

You may not qualify if:

  • Patients with NYHA class I or IV.
  • Sustained ventricular tachycardia (\>30 sec) or with hemodynamic compromise.
  • Presence of permanent pacemaker or implantable defibrillator.
  • Systolic blood pressure \< 90 mmHg.
  • Heart beat \< 60 bpm at rest.
  • Advanced renal insufficiency (estimated glomerular filtration rate (GFR) \< 30 ml/min/1.73 square meters).
  • Patients with planned cardiac surgery or percutaneous revascularization.
  • Other reasons which would preclude the patient from participating in the study (comorbidities, life expectancy less than 1 year).
  • Unsuitable anatomy of renal arteries, renal stenosis or previous treatment with balloon or stent.
  • Refusal of the patient.

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 FailureHeart Failure, SystolicChagas DiseaseChagas Cardiomyopathy

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesTrypanosomiasisEuglenozoa InfectionsProtozoan InfectionsParasitic DiseasesInfectionsVector Borne DiseasesCardiomyopathies

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
Professor of Medicine

Study Record Dates

First Submitted

March 19, 2014

First Posted

March 31, 2014

Study Start

March 1, 2014

Primary Completion

December 1, 2014

Study Completion

August 1, 2015

Last Updated

March 31, 2014

Record last verified: 2014-03

Locations

BR(1)