Clinical trial NCT04047901: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Insufficiency;Cardiac
Cancer
Cardiotoxicity
Heart Failure
Keywords: autonomic dysfunction
baroreflex control
ergorreflex control
muscle myopaty
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: InCor Heart Institute
name: Cancer Institute of Sao Paulo
name: Hospital Sirio-Libanes
First posted: 2019-08-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled clinical trial
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Measure muscular sympathetic nervous activity
timeFrame: 16 weeks
Secondary outcomes:
measure: Evaluate baroreflex activity
timeFrame: 16 weeks
measure: Evaluate quimiorreflex sensibility
timeFrame: 16 weeks
measure: Evaluate Mecanorreflex control
timeFrame: 16 weeks
measure: Evaluate metaborreflex control
timeFrame: 16 weeks
measure: Evaluation of skeletal myopathy
timeFrame: 16 weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Heart Institute of University of São Paulo
state: Sao Paulo
Study officials:
References: