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

NCT ID: NCT04047901

Last Updated: 2019-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-07

Study Completion Date

2021-02-28

Brief Summary

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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

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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

Conditions

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Insufficiency;Cardiac Cancer Cardiotoxicity Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

exercise training

Intervention Type OTHER

Patients undergo 16 weeks of physical training

Interventions

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exercise training

Patients undergo 16 weeks of physical training

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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InCor Heart Institute

OTHER

Sponsor Role collaborator

Cancer Institute of Sao Paulo

UNKNOWN

Sponsor Role collaborator

Hospital Sirio-Libanes

OTHER

Sponsor Role collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Heart Institute of University of São Paulo

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Amanda Gonzales Rodrigues

Role: CONTACT

+55(11)999468264

Carlos Eduardo Negrao, PHD

Role: CONTACT

+55(11)26615043

Facility Contacts

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Amanda Gonzales Rodrigues

Role: primary

+55(11)999468264

Carlos Eduardo Negrao, PHD

Role: backup

+55(11)26615043

Other Identifiers

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SDC COP 002/15/002

Identifier Type: -

Identifier Source: org_study_id

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