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Completed

NCT Number: NCT03550872

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.

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Key information

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Heart Institute of Hospiral Clinics of the University of São Paulo Medical School

São Paulo, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • High-frequency ventricular response;
  • Neuromuscular / neuropathy disease;
  • Physical and mental impairment;
  • Chronic obstructive pulmonary disease;
  • Diabetes mellitus;
  • Decompensated arterial hypertension;
  • 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.

Treatment and study plan

physical training

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Muscle Sympathetic Nervous Activity Assessment

    Time frame: Two year

    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.

  2. Measurement of Muscle Blood Flow

    Time frame: Two year

    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.

  3. Evaluation of endothelium-dependent vascular function

    Time frame: Two year

    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.

  4. Evaluation of neurovascular control during mental stress

    Time frame: Two

    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.

  5. Measurement of Pulse Wave Velocity (PWV)

    Time frame: Two year

    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.

  6. Evaluation of cardiac structure and function

    Time frame: Two year

    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.

  7. Evaluation of the concentration of plasma biomarkers

    Time frame: Two year

    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.

  8. Quality of life assessment

    Time frame: Two year

    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.

  9. Assessment of cognitive function

    Time frame: Two year

    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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study title

Effect of Exercise Training in Patients With Heart Failure and Permanent Atrial Fibrillation

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 8, 2018
Registry last updated
Jun 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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