Heart FailureNCT03550872
Exercise Training in Patients With Heart Failure and Permanent Atrial Fibrillation
A study testing Physical Training in people with Heart Failure and Atrial Fibrillation, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The positive effect of physical training in patients with heart failure (HF) has been increasingly established. However, the presence of atrial fibrillation (AF), mainly in its permanent form, makes the clinical condition of the patients more compromised. Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Atrial Fibrillation
- What is being tested?
- Physical Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteBrazil
- Study dates
- 21 Jun 2015to 30 Oct 2017
- 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 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with clinically stable NYHA class II to III heart failure with permanent atrial fibrillation (AF);
- Left ventricular ejection fraction ≤40%;
- Patients refractory and / or no indication of the treatment of reversal to the rhythm;
- Patients in optimization specific drug therapy for HF and AF.
Who cannot join
- High-frequency ventricular response;
- Neuromuscular / neuropathy disease;
- Physical and mental impairment;
- Chronic obstructive pulmonary disease;
- Diabetes mellitus;
- Decompensated arterial hypertension;
Show all 22Show fewer
- Autonomic neuropathy;
- Recent myocardial infarction (<6 months);
- Ventricular arrhythmias;
- Atrial flutter;
- Renal failure;
- Use implantable electronic cardiac device or indication for implantation;
- Pregnancy;
- NYHA Functional Class IV;
- Resting heart rate <55 bpm;
- Wolff Parkinson White Syndrome;
- Thyroid dysfunction;
- Unstable angina;
- Recent history of thromboembolic event;
- Inability to sign the consent form;
- Participation in regular physical training program;
- Use of alcoholic beverages.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Heart Institute of Hospiral Clinics of the University of São Paulo Medical School
São Paulo, São Paulo
About this study
Official title: Effect of Exercise Training in Patients With Heart Failure and Permanent Atrial Fibrillation
The positive effect of physical training in patients with heart failure (HF) has been increasingly established. However, the presence of atrial fibrillation (AF), mainly in its permanent form, makes the clinical condition of the patients more compromised.
Read the detailed description
The positive effect of physical training in patients with heart failure (HF) has been increasingly established. However, the presence of atrial fibrillation (AF), mainly in its permanent form, makes the clinical picture of these patients more compromised. The literature has not yet demonstrated studies involving indication of physical exercise therapy when AF is associated with HF. Thus, the hypothesis is that physical training improves functional capacity, cerebral oxygenation, autonomic aspects, vascular aspects, cardiac function, plasma markers, quality of life and cognitive function of these patients.
- Conditions
- Heart Failure, Atrial Fibrillation
- Being tested
- Physical Training
- Keywords
- heart failure, atrial fibrillation and exercise training
- Medical subject headings
- Heart Failure, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical TrainingBehavioural
Participants will perform physical training three times a week on a stationary bicycle. The exercise intensity will be controlled between 14 and 16 by the Borg Scale for 40 minutes
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Patients in the group who are continuously guided as the activities of daily living normally avoiding participation in any regular program of physical exercise does not proceed from the study. |
| Training Group | Experimental | the patients randomized to the physical training group will undergo the supervised physical training program Receives: Behavioral: Physical Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Capacity Assessement
unctional function is assessed by measuring oxygen consumption (VO2). Multidimensional electrocardiography logo will be connected to a computerized system through a remote and tracheal control system. Through Oxygen Detergent (O2) and carbon dioxide (CO2) the concentrations of O2 and CO2, respectively, are analyzed for each respiratory cycle.
Measured: two year
Secondary outcomes (9)
Muscle Sympathetic Nervous Activity Assessment
Muscle sympathetic nerve activity will be measured by the direct technique of multiple recording units of the efferent postganglionic pathway, the fascicle of the muscular nerve, in the fibular nerve, immediately inferior to the head of the fibula, in the leg. The experiments will be performed in an electrically isolated room with supine individuals. The records will be obtained by implanting a microelectrode on the fibular nerve and a reference microelectrode approximately one to one centimeter away from the first.
Measured: Two year
Measurement of Muscle Blood Flow
The muscular blood flow will be evaluated by the venous occlusion plethysmography technique. The patient will be placed in the dorsal position with the arm elevated above the heart. The silicone-filled mercury-filled tube attached to a low pressure transducer will be placed around the forearm and connected to the plethysmograph.
Measured: Two year
Evaluation of endothelium-dependent vascular function
Endothelium-dependent vascular function will be assessed by muscle vasodilation during isometric manual retention exercise with 30% maximal voluntary contraction for 3 minutes. The level of effort perception will be assessed by the Borg scale.
Measured: Two year
Evaluation of neurovascular control during mental stress
After this period, the ANSM, FSM, PA, FC, and FR responses will be evaluated during the application of the Stroop Color Word test. This test consists of a table that has a series of color names, written with an ink different from that of the meaning of the word. The patient should say "high" and as soon as possible in what color the word is written and not the meaning of the word. This procedure will be done as follows: 3 minutes baseline, 4 minutes color test and 2 minutes recovery. At the end of the test will be asked each patient, the degree of difficulty of the color test. This will be done from a standard table of degree of difficulty: 0 = not stressful; 1 = a little stressful; 2 = stressful; 3 = very stressful; 4 = extremely stressful.
Measured: Two
Measurement of Pulse Wave Velocity (PWV)
VOP will be measured non-invasively using VICORDER® equipment (medical CE, IEC, FDA). Measurements will be obtained using a 100 mm cuff of blood around the thigh to measure the femoral pulse and a partial cuff of 30 millimeters around the neck at the level of the carotid artery. The cuffs will be inflated every 60mmHg, and the high-quality waveforms will be recorded simultaneously for 3 seconds, with the patients positioned in the supine position using a volume-shifting method. The wave impulse transition time will be determined using a cross-correlation algorithm. The length of the path will be defined as the distance between the sternum furcula and the upper part of the thigh sheath as indicated by the manufacturer.
Measured: Two year
Evaluation of cardiac structure and function
For the evaluation of the cardiac function, the patients will be submitted to a one-dimensional (M-mode), two-dimensional transthoracic echocardiographic study with pulsed, continuous and color Doppler echocardiography. The Sequoia 512 (Acuson, Mountain View, CA) will be used with the 2.5-4.0 Mhz 3V2c coupled multifrequency transducer. The exams were recorded on DVD.
Patients will be positioned and examined. Three electrocardiographic electrodes will be placed on the chest wall for simultaneous recording of the electrocardiogram in the ultrasound system and the parasternal long axis, parasternal short axis, aorta / AE, mitral valve and papillary and apical levels, in 4 and 2 rooms.
Measured: Two year
Evaluation of the concentration of plasma biomarkers
For the determination of the plasma concentration of Norepinephrine (NE), Natriuretic Atrial Peptide (ANP), Cerebral Natriuretic Peptide (BNP), Interleukin-6 (I-6) and Tumor Necrosis Factor- (TNF-alpha) and Angiotensin II, two peripheral blood collections were performed at different times (pre and post training). At each moment 3 ml of blood will be collected in tubes containing EDTA. The supernatant (plasma) will be removed and transferred to two eppendorf microtubes (proof and counter-proof) where they will be stored at -80º C until the moment of analysis. Samples will be quantified at the Genesis Laboratory (São Paulo / SP) using the enzyme immunoassay technique (ELISA) according to standardized laboratory protocols.
Measured: Two year
Quality of life assessment
he Minnesota Living With Heart Failure Questionnaire will be used in its validated Portuguese version74, which evaluates scores of quality of life limitations, addressing the physical, emotional and total score dimensions. It is a questionnaire of 21 questions regarding the limitations that are frequently associated with heart failure and should consider the last month to respond to the questionnaire. The scale of responses for each question ranges from 0 (zero) to 5 (five), where 0 represents without limitations and the maximum limitation. For the physical dimension score is calculated the sum of eight questions (2, 3, 4, 5, 6, 7, 12 and 13) that are highly interrelated with dyspnea and fatigue; the emotional dimension score is composed of five questions (17, 18, 19, 20 and 21); the other questions (1, 8, 9, 10, 11, 14, 15 and 16) added to the questions related to the physical and emotional dimensions, form the total score.
Measured: Two year
Assessment of cognitive function
Cognitive assessment will be performed through the Mini Mental State Examination (MMSE) 75. This questionnaire is used to evaluate the overall cognitive state (general cognitive state) and is divided into seven categories: temporal orientation, spatial orientation, three-word register, attention and calculation, three-word recall, language and visuo-constructive ability. The MMSE has a score of 0 to 30 points, and the lower the score the higher the indication of cognitive decline.
Measured: Two year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start21 Jun 2015
- Primary completion30 Sep 2017
- Study completion30 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- To evaluate the physical effect of physical training in patients with heart failure and permanent atrial fibrillation
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guilherme Veiga Guimarães, Principal investigator, Institute of Heart of the Sao Paulo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03550872
- Sponsor's protocol ID
- Heart of Institute
- Status last verified
- May 2017
- First submitted
- 23 May 2018
- Last updated
- 8 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise Training in Patients With Heart Failure and Permanent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03550872
- Acronym / sponsor ID
- Heart of Institute
- Conditions
- Heart Failure, Atrial Fibrillation
- Keywords
- heart failure, atrial fibrillation and exercise training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 21 Jun 2015
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Oct 2017 (actual)
- First posted
- 8 Jun 2018 (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.
The positive effect of physical training in patients with heart failure (HF) has been increasingly established. However, the presence of atrial fibrillation (AF), mainly in its permanent form, makes the clinical condition of the patients more compromised.
Detailed description
The positive effect of physical training in patients with heart failure (HF) has been increasingly established. However, the presence of atrial fibrillation (AF), mainly in its permanent form, makes the clinical picture of these patients more compromised. The literature has not yet demonstrated studies involving indication of physical exercise therapy when AF is associated with HF. Thus, the hypothesis is that physical training improves functional capacity, cerebral oxygenation, autonomic aspects, vascular aspects, cardiac function, plasma markers, quality of life and cognitive function of these patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- To evaluate the physical effect of physical training in patients with heart failure and permanent atrial fibrillation
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Patients in the group who are continuously guided as the activities of daily living normally avoiding participation in any regular program of physical exercise does not proceed from the study. |
| Training Group | Experimental | Behavioral: Physical Trainingthe patients randomized to the physical training group will undergo the supervised physical training program |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with clinically stable NYHA class II to III heart failure with permanent atrial fibrillation (AF);
- Left ventricular ejection fraction ≤40%;
- Patients refractory and / or no indication of the treatment of reversal to the rhythm;
- Patients in optimization specific drug therapy for HF and AF.
Key exclusion criteria (22 listed)
- High-frequency ventricular response;
- Neuromuscular / neuropathy disease;
- Physical and mental impairment;
- Chronic obstructive pulmonary disease;
- Diabetes mellitus;
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 |
|---|---|---|
| Physical TrainingParticipants will perform physical training three times a week on a stationary bicycle. The exercise intensity will be controlled between 14 and 16 by the Borg Scale for 40 minutes | Behavioural | Training Group |
Primary outcome
Functional Capacity Assessement
Time frame: two year
unctional function is assessed by measuring oxygen consumption (VO2). Multidimensional electrocardiography logo will be connected to a computerized system through a remote and tracheal control system. Through Oxygen Detergent (O2) and carbon dioxide (CO2) the concentrations of O2 and CO2, respectively, are analyzed for each respiratory cycle.
9 secondary outcomes
Muscle Sympathetic Nervous Activity Assessment
Time frame: Two year
Measurement of Muscle Blood Flow
Time frame: Two year
Evaluation of endothelium-dependent vascular function
Time frame: Two year
Evaluation of neurovascular control during mental stress
Time frame: Two
Measurement of Pulse Wave Velocity (PWV)
Time frame: Two year
Evaluation of cardiac structure and function
Time frame: Two year
Evaluation of the concentration of plasma biomarkers
Time frame: Two year
Quality of life assessment
Time frame: Two year
Assessment of cognitive function
Time frame: Two year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2018.
- 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.
Guilherme Veiga Guimarães principal investigator
Institute of Heart of the Sao Paulo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Training in people with Heart Failure and Atrial Fibrillation, 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 22 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: finished, as of the sponsor's last update on 8 Jun 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Capacity Assessement (time frame: two year). 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 8 Jun 2018.