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Effect of Physical Training in Patients With Heart Failure Caused by Chemotherapy for Cancer Treatment

Primary Purpose

Insufficiency;Cardiac, Cancer, Cardiotoxicity

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
exercise training
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insufficiency;Cardiac focused on measuring autonomic dysfunction, baroreflex control, ergorreflex control, muscle myopaty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age 18 years old
  • Funcional Class I-III (NYHA)
  • Ejection fraction < o,55
  • treated for heart failure

Exclusion Criteria:

  • Coronary artery disease
  • Moderate to major valve disease
  • Positive serology for Chagas
  • Inability to perform physical exercises

Sites / Locations

  • Heart Institute of University of São PauloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control group

Training group

Arm Description

A group of patients who will not be trained will be evaluated at baseline (pre) and after 16 weeks. They are oriented to maintain lifestyle changes

Patients will complete 16 weeks of training including 40 minutes of aerobic training, 15 minutes of resistive exercise and 5 minutes of relaxation.

Outcomes

Primary Outcome Measures

Measure muscular sympathetic nervous activity
The sympathetic nervous activity is assessed by the microneurography technique

Secondary Outcome Measures

Evaluate baroreflex activity
Evaluation of muscular sympathetic nervous activity at rest by the technique of microneurography, evaluation of the muscular blood flow by venous occlusion plethysmography technique
Evaluate quimiorreflex sensibility
Evaluation of muscular sympathetic nervous activity at rest by the technique of microneurography, evaluation of the muscular blood flow by venous occlusion plethysmography technique
Evaluate Mecanorreflex control
Evaluation of muscular sympathetic nervous activity at rest by the technique of microneurography, evaluation of the muscular blood flow by venous occlusion plethysmography technique
Evaluate metaborreflex control
Evaluation of muscular sympathetic nervous activity at rest by the technique of microneurography, evaluation of the muscular blood flow by venous occlusion plethysmography technique
Evaluation of skeletal myopathy
muscle biopsy

Full Information

First Posted
March 29, 2019
Last Updated
August 5, 2019
Sponsor
University of Sao Paulo General Hospital
Collaborators
InCor Heart Institute, Cancer Institute of Sao Paulo, Hospital Sirio-Libanes
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1. Study Identification

Unique Protocol Identification Number
NCT04047901
Brief Title
Effect of Physical Training in Patients With Heart Failure Caused by Chemotherapy for Cancer Treatment
Official Title
Effect of Physical Training in Patients With Heart Failure Caused by Chemotherapy for Cancer Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 7, 2016 (Actual)
Primary Completion Date
February 2021 (Anticipated)
Study Completion Date
February 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
InCor Heart Institute, Cancer Institute of Sao Paulo, Hospital Sirio-Libanes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
New therapies for cancer increased patient survival, but led to the recognition of adverse effects associated with cancer treatment, such as the use of chemotherapy. Cardiotoxicity is the most significant adverse effect, which affect the functional capacity and quality of life and is associated with high morbidity and mortality, regardless of the oncological prognosis. One of the manifestations of cardiotoxicity is ventricular dysfunction that can lead to heart failure. Neuro humoral hyperactivation with increased sympathetic nerve activity is a typical manifestation of heart failure and is associated with worse prognosis. Studies have shown that physical training significantly reduces sympathetic nerve activity in addition to improving muscle blood flow, reversing effects on skeletal muscle and improving quality of life. The hypothesis is that physical training may reduce sympathetic nerve activity and vasoconstrictor status in patients with heart failure caused by anthracyclines, as well as improving baroreflex and chemoreflex sensibility, mechanoreflex and metaborreflex control and skeletal myopathy.
Detailed Description
The investigators included patients> 18 years, left ventricular ejection fraction <= 0.55, functional class (NYHA) I-III, under medical treatment for heart failure. Patients with coronary artery disease, moderate to severe valve disease, positive Chagas serology, inability to participate in an exercise program are excluded. Primary outcome: Muscle sympathetic nerve activity Secondary outcome: arterial baroreflex sensitivity, peripheral chemorreflex sensitivity, mecanic and muscuclar metaborreflex control, ubiquitin proteasome system activity. Patients were divided into 2 groups-trained (n = 10) and non-trained (n = 10). Patients in the trained group will complete 16 weeks of aerobic training. Evaluation of cardiac function, functional capacity, quality of life and biochemical evaluation (troponin, hs-CRP and BNP). For muscle evaluation will be performed biopsy of the vastus lateralis muscle

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insufficiency;Cardiac, Cancer, Cardiotoxicity, Heart Failure
Keywords
autonomic dysfunction, baroreflex control, ergorreflex control, muscle myopaty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Description
A group of patients who will not be trained will be evaluated at baseline (pre) and after 16 weeks. They are oriented to maintain lifestyle changes
Arm Title
Training group
Arm Type
Experimental
Arm Description
Patients will complete 16 weeks of training including 40 minutes of aerobic training, 15 minutes of resistive exercise and 5 minutes of relaxation.
Intervention Type
Other
Intervention Name(s)
exercise training
Intervention Description
Patients undergo 16 weeks of physical training
Primary Outcome Measure Information:
Title
Measure muscular sympathetic nervous activity
Description
The sympathetic nervous activity is assessed by the microneurography technique
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Evaluate baroreflex activity
Description
Evaluation of muscular sympathetic nervous activity at rest by the technique of microneurography, evaluation of the muscular blood flow by venous occlusion plethysmography technique
Time Frame
16 weeks
Title
Evaluate quimiorreflex sensibility
Description
Evaluation of muscular sympathetic nervous activity at rest by the technique of microneurography, evaluation of the muscular blood flow by venous occlusion plethysmography technique
Time Frame
16 weeks
Title
Evaluate Mecanorreflex control
Description
Evaluation of muscular sympathetic nervous activity at rest by the technique of microneurography, evaluation of the muscular blood flow by venous occlusion plethysmography technique
Time Frame
16 weeks
Title
Evaluate metaborreflex control
Description
Evaluation of muscular sympathetic nervous activity at rest by the technique of microneurography, evaluation of the muscular blood flow by venous occlusion plethysmography technique
Time Frame
16 weeks
Title
Evaluation of skeletal myopathy
Description
muscle biopsy
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age 18 years old Funcional Class I-III (NYHA) Ejection fraction < o,55 treated for heart failure Exclusion Criteria: Coronary artery disease Moderate to major valve disease Positive serology for Chagas Inability to perform physical exercises
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amanda Gonzales Rodrigues
Phone
+55(11)999468264
Email
amanda.rodrigues@incor.usp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Carlos Eduardo Negrao, PHD
Phone
+55(11)26615043
Facility Information:
Facility Name
Heart Institute of University of São Paulo
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
05403-900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda Gonzales Rodrigues
Phone
+55(11)999468264
Email
amanda.rodrigues@incor.usp.br
First Name & Middle Initial & Last Name & Degree
Carlos Eduardo Negrao, PHD
Phone
+55(11)26615043
Email
carlos.negrao@incor.usp.br
First Name & Middle Initial & Last Name & Degree
Roberto Kalil Filho, PHD

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Physical Training in Patients With Heart Failure Caused by Chemotherapy for Cancer Treatment

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