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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04047901
Enrollment
20
Registered
2019-08-07
Start date
2016-11-07
Completion date
2021-02-28
Last updated
2019-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Cardiotoxicity, Heart Failure, Insufficiency;Cardiac

Keywords

autonomic dysfunction, baroreflex control, ergorreflex control, muscle myopaty

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

Interventions

OTHERexercise training

Patients undergo 16 weeks of physical training

Sponsors

InCor Heart Institute
CollaboratorOTHER
Cancer Institute of Sao Paulo
CollaboratorUNKNOWN
Hospital Sirio-Libanes
CollaboratorOTHER
University of Sao Paulo General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

randomized controlled clinical trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Measure muscular sympathetic nervous activity16 weeksThe sympathetic nervous activity is assessed by the microneurography technique

Secondary

MeasureTime frameDescription
Evaluate baroreflex activity16 weeksEvaluation 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 sensibility16 weeksEvaluation 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 control16 weeksEvaluation 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 control16 weeksEvaluation 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 myopathy16 weeksmuscle biopsy

Countries

Brazil

Contacts

Primary ContactAmanda Gonzales Rodrigues
amanda.rodrigues@incor.usp.br+55(11)999468264
Backup ContactCarlos Eduardo Negrao, PHD
+55(11)26615043

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026