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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04047901
• Other study ID #: SDC COP 002/15/002
• Status: Recruiting
• Phase: N/A
• Start date: November 7, 2016
• Est. completion date: February 2021

Study information

• Verified date: March 2019
• Source: University of Sao Paulo General Hospital
• Contact: Amanda Gonzales Rodrigues
• Phone: +55(11)999468264
• Email: amanda.rodrigues[@]incor.usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 2021
• Est. primary completion date: February 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Cardiotoxicity
• Heart Failure
• Insufficiency;Cardiac

Intervention

Other:
• exercise training
Patients undergo 16 weeks of physical training

Locations

Country	Name	City	State
Brazil	Heart Institute of University of São Paulo	São Paulo	Sao Paulo

Sponsors (4)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Cancer Institute of Sao Paulo, Hospital Sirio-Libanes, InCor Heart Institute

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure muscular sympathetic nervous activity	The sympathetic nervous activity is assessed by the microneurography technique	16 weeks
Secondary	Evaluate baroreflex activity	Evaluation of muscular sympathetic nervous activity at rest by the technique of microneurography, evaluation of the muscular blood flow by venous occlusion plethysmography technique	16 weeks
Secondary	Evaluate quimiorreflex sensibility	Evaluation of muscular sympathetic nervous activity at rest by the technique of microneurography, evaluation of the muscular blood flow by venous occlusion plethysmography technique	16 weeks
Secondary	Evaluate Mecanorreflex control	Evaluation of muscular sympathetic nervous activity at rest by the technique of microneurography, evaluation of the muscular blood flow by venous occlusion plethysmography technique	16 weeks
Secondary	Evaluate metaborreflex control	Evaluation of muscular sympathetic nervous activity at rest by the technique of microneurography, evaluation of the muscular blood flow by venous occlusion plethysmography technique	16 weeks
Secondary	Evaluation of skeletal myopathy	muscle biopsy	16 weeks