Insufficiency;CardiacNCT04047901
Effect of Physical Training in Patients With Heart Failure Caused by Chemotherapy for Cancer Treatment
A study testing exercise training in people with Insufficiency;Cardiac and Cancer, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insufficiency;Cardiac, Cancer, Cardiotoxicity
- What is being tested?
- exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 7 Nov 2016to Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 years old
- Funcional Class I-III (NYHA)
- Ejection fraction < o,55
- treated for heart failure
Who cannot join
- Coronary artery disease
- Moderate to major valve disease
- Positive serology for Chagas
- Inability to perform physical exercises
Trial locations and contacts
1 site in 1 country.
Carlos Eduardo Negrao, PHD contact
Brazil1 site, 1 recruiting
- Recruiting
Heart Institute of University of São Paulo
São Paulo, São Paulo, 05403-900
Amanda Gonzales Rodrigues, +55(11)999468264, amanda.rodrigues@incor.usp.br
Carlos Eduardo Negrao, PHD, +55(11)26615043, carlos.negrao@incor.usp.br
About this study
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.
Read the 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
- Conditions
- Insufficiency;Cardiac, Cancer, Cardiotoxicity, Heart Failure
- Being tested
- exercise training
- Keywords
- autonomic dysfunction, baroreflex control, ergorreflex control, muscle myopaty
- Medical subject headings
- Heart Failure, Neoplasms, Cardiotoxicity, Primary Dysautonomias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise trainingOther
Patients undergo 16 weeks of physical training
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | 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 |
| Training group | Experimental | Patients will complete 16 weeks of training including 40 minutes of aerobic training, 15 minutes of resistive exercise and 5 minutes of relaxation. Receives: Other: exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure muscular sympathetic nervous activity
The sympathetic nervous activity is assessed by the microneurography technique
Measured: 16 weeks
Secondary outcomes (5)
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
Measured: 16 weeks
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
Measured: 16 weeks
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
Measured: 16 weeks
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
Measured: 16 weeks
Evaluation of skeletal myopathy
muscle biopsy
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start7 Nov 2016
- Primary completionFeb 2021 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insufficiency;CardiacStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled clinical trial
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- InCor Heart Institute, Cancer Institute of Sao Paulo, Hospital Sirio-Libanes
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04047901
- Sponsor's protocol ID
- SDC COP 002/15/002
- Status last verified
- Mar 2019
- First submitted
- 29 Mar 2019
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Physical Training in Patients With Heart Failure Caused by Chemotherapy for Cancer Treatment
- ClinicalTrials.gov ID
- NCT04047901
- Acronym / sponsor ID
- SDC COP 002/15/002
- Conditions
- Insufficiency;Cardiac, Cancer, Cardiotoxicity, Heart Failure
- Keywords
- autonomic dysfunction, baroreflex control, ergorreflex control, muscle myopaty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- InCor Heart Institute, Cancer Institute of Sao Paulo, Hospital Sirio-Libanes
- Study start
- 7 Nov 2016 (actual)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 7 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –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 |
| Training group | Experimental | Other: exercise trainingPatients will complete 16 weeks of training including 40 minutes of aerobic training, 15 minutes of resistive exercise and 5 minutes of relaxation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18 years old
- Funcional Class I-III (NYHA)
- Ejection fraction < o,55
- treated for heart failure
Key exclusion criteria (4 listed)
- Coronary artery disease
- Moderate to major valve disease
- Positive serology for Chagas
- Inability to perform physical exercises
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise trainingPatients undergo 16 weeks of physical training | Other | Training group |
Primary outcome
Measure muscular sympathetic nervous activity
Time frame: 16 weeks
The sympathetic nervous activity is assessed by the microneurography technique
5 secondary outcomes
Evaluate baroreflex activity
Time frame: 16 weeks
Evaluate quimiorreflex sensibility
Time frame: 16 weeks
Evaluate Mecanorreflex control
Time frame: 16 weeks
Evaluate metaborreflex control
Time frame: 16 weeks
Evaluation of skeletal myopathy
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Eduardo Negrao, PHD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise training in people with Insufficiency;Cardiac and Cancer, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amanda Gonzales Rodrigues (+55(11)999468264, amanda.rodrigues@incor.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure muscular sympathetic nervous activity (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2019.