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

Sponsor
University of Sao Paulo General Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT04047901
Collaborator
InCor Heart Institute (Other), Cancer Institute of Sao Paulo (Other), Hospital Sirio-Libanes (Other)
20
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: exercise training
N/A

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
randomized controlled clinical trialrandomized 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 :
Nov 7, 2016
Anticipated Primary Completion Date :
Feb 1, 2021
Anticipated Study Completion Date :
Feb 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Measure muscular sympathetic nervous activity [16 weeks]

    The sympathetic nervous activity is assessed by the microneurography technique

Secondary Outcome Measures

  1. Evaluate baroreflex activity [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 [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 [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 [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 [16 weeks]

    muscle biopsy

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Heart Institute of University of São Paulo São Paulo Sao Paulo Brazil 05403-900

Sponsors and Collaborators

  • University of Sao Paulo General Hospital
  • InCor Heart Institute
  • Cancer Institute of Sao Paulo
  • Hospital Sirio-Libanes

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT04047901
Other Study ID Numbers:
  • SDC COP 002/15/002
First Posted:
Aug 7, 2019
Last Update Posted:
Aug 7, 2019
Last Verified:
Mar 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 7, 2019