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

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ClinicalTrials.gov Identifier: NCT04047901
Recruitment Status : Recruiting
First Posted : August 7, 2019
Last Update Posted : August 7, 2019
Sponsor:
Collaborators:
InCor Heart Institute
Cancer Institute of Sao Paulo
Hospital Sirio-Libanes
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

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.

Condition or disease Intervention/treatment Phase
Insufficiency;Cardiac Cancer Cardiotoxicity Heart Failure Other: exercise training Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized controlled clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Physical Training in Patients With Heart Failure Caused by Chemotherapy for Cancer Treatment
Actual Study Start Date : November 7, 2016
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
No Intervention: control group

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

Experimental: Training group
Patients will complete 16 weeks of training including 40 minutes of aerobic training, 15 minutes of resistive exercise and 5 minutes of relaxation.
Other: exercise training
Patients undergo 16 weeks of physical training




Primary Outcome Measures :
  1. Measure muscular sympathetic nervous activity [ Time Frame: 16 weeks ]
    The sympathetic nervous activity is assessed by the microneurography technique


Secondary Outcome Measures :
  1. Evaluate baroreflex activity [ Time Frame: 16 weeks ]
    Evaluation of muscular sympathetic nervous activity at rest by the technique of microneurography, evaluation of the muscular blood flow by venous occlusion plethysmography technique

  2. Evaluate quimiorreflex sensibility [ Time Frame: 16 weeks ]
    Evaluation of muscular sympathetic nervous activity at rest by the technique of microneurography, evaluation of the muscular blood flow by venous occlusion plethysmography technique

  3. Evaluate Mecanorreflex control [ Time Frame: 16 weeks ]
    Evaluation of muscular sympathetic nervous activity at rest by the technique of microneurography, evaluation of the muscular blood flow by venous occlusion plethysmography technique

  4. Evaluate metaborreflex control [ Time Frame: 16 weeks ]
    Evaluation of muscular sympathetic nervous activity at rest by the technique of microneurography, evaluation of the muscular blood flow by venous occlusion plethysmography technique

  5. Evaluation of skeletal myopathy [ Time Frame: 16 weeks ]
    muscle biopsy



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04047901


Contacts
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Contact: Amanda Gonzales Rodrigues +55(11)999468264 amanda.rodrigues@incor.usp.br
Contact: Carlos Eduardo Negrao, PHD +55(11)26615043

Locations
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Brazil
Heart Institute of University of São Paulo Recruiting
São Paulo, Sao Paulo, Brazil, 05403-900
Contact: Amanda Gonzales Rodrigues    +55(11)999468264    amanda.rodrigues@incor.usp.br   
Contact: Carlos Eduardo Negrao, PHD    +55(11)26615043    carlos.negrao@incor.usp.br   
Principal Investigator: Roberto Kalil Filho, PHD         
Sponsors and Collaborators
University of Sao Paulo General Hospital
InCor Heart Institute
Cancer Institute of Sao Paulo
Hospital Sirio-Libanes

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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT04047901     History of Changes
Other Study ID Numbers: SDC COP 002/15/002
First Posted: August 7, 2019    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Sao Paulo General Hospital:
autonomic dysfunction
baroreflex control
ergorreflex control
muscle myopaty
Additional relevant MeSH terms:
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Heart Failure
Cardiotoxicity
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries