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Completed

NCT Number: NCT03218891

Cardiac Rehabilitation in Patients With Refractory Angina

The purpose of this study is to evaluate the safety and feasibility of cardiovascular rehabilitation in Patients with refractory angina, evaluate the effect of cardiovascular rehabilitation in patients with angina Refractory, by maximal oxygen consumption (VO2max) and global myocardial ischemic load by Stress Echocardiography; To evaluate the presence of myocardial injury, caused by physical stress, through ultra-sensitive troponin after sessions of aerobic physical activity, evaluating the behavior during the training period; To evaluate the effect of rehabilitation on the modulation of sympathetic activity and inflammation, muscular blood flow and lipid metabolism; To evaluate of the effect of rehabilitation on ventricular function through Stress echocardiography; Detection of ischemic episodes and arrhythmias identified during the Rehabilitation sessions through external cardiac monitoring (telemetry); Evaluate the quality of life assessment through the SF-36 questionnaire, Canadian Cardiovascular Society, the number of symptomatic episodes of ischemia, daily sublingual nitrate intake.

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Key information

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Israelita de Ensino e Pesquisa Albert Einstein 's (IIEP)

São Paulo, 05652-000, Brazil

About this study

After signing the informed consent form, patients will be randomized into 4 groups: 1. Optimized clinical treatment group + physical training for 12 weeks (TF); 2. optimized clinical treatment group (CT); 3. Group with coronary insufficiency without angina (CD); Group 4: normal healthy subjects All patients will be submitted to the following procedures in 2 moments * (times 0 and 3): -Routine laboratory tests including study of total cholesterol, LDL-cholesterol, -HDL-cholesterol, including study of the functionality of HDL-c, triglycerides, complete blood count, renal function, fasting glycemia, glycosylated hemoglobin (HbA1C); - Dosage of biomarkers of myocardial ischemia (ultra-sensitive troponin); - Dosage of inflammatory markers: Tumor necrosis factor (TNFn), interleukins 1 and 6 (IL-1 and IL-6), ultra-sensitive C-reactive protein (CRP); - Vascular endothelial growth factor (VEGF) dosage; - ergospirometric test in cycloergometer; - Echocardiogram with physical stress with evaluation of myocardial perfusion and function; - Evaluation of sympathetic activity through microneurography; - Evaluation of vascular reactivity through ultrasound of the brachial artery. - Evaluation of muscular blood flow through plethysmography; - Isometric exercise protocols; - Mental stress protocol - Quality of Life Questionnaire; - Diary of angina. After the initial examinations, the candidates of the TF group will be evaluated by cardiovascular rehabilitation team, for training prescription, which will be performed in a hospital environment, supervised by a qualified doctor. The rehabilitation may be interrupted in any patient, for safety measure, if the investigator deems it appropriate. All patients in both groups will receive clinical follow-up during the protocol, with monthly consultations during the 12-week protocol period (time 0 to 3), in which clinical evaluations of symptoms and quality of life of the patients will be performed . Any clinical intercurrence will be promptly annotated and evaluated according to the need of the moment. After this period, routine outpatient follow-up is scheduled at the outpatient clinic, and counseling for unsupervised physical training, according to the results of the study. All laboratory, clinical, imaging, and functional parameters will be evaluated before and at the end of the protocol.

Who can participate

Healthy volunteers accepted: Yes

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

Group 1 and 2

Inclusion criteria

  • Stable angina functional class II to IV according to the classification of Canadian Cardiovascular Society (CCS) 39, or limiting angina in Perception of the patient;
  • Documented myocardial ischemia by imaging method;
  • Patients not eligible for myocardial revascularization procedures surgical conventional, due to the unfavorable anatomy;
  • Signature of the Free and Informed Consent Form.

Exclusion criteria

  • Patients with definitive pacemaker or implantable cardioverter defibrillator (ICD);
  • Patients with non-sinus heart rhythm;
  • Patients with complete intraventricular block;
  • Acute coronary syndrome (myocardial infarction or unstable angina) or previous procedures for myocardial revascularization (angioplasty / surgery) less than 3 months;
  • Functional impossibility (orthopedic, rheumatic, neurological, or otherwise) or social for participation in the Rehabilitation Program;
  • Classification of risk for American Heart Association class D physical training (unstable ischemia, stenosis or severe or symptomatic valve insufficiency, congenital heart disease, decompensated heart failure, uncontrolled arrhythmias and other conditions that may be aggravated by exercise).

Group 3

Inclusion criteria

  • Patients with coronary insufficiency without angina;
  • Signature of the Free and Informed Consent Form.

Group 4

Inclusion criteria

  • Signature of the Free and Informed Consent Form;
  • Healthy;
  • Non-smokers;
  • Sedentary

Treatment and study plan

Cardiac rehabilitation

Behavioral

The physical training program will start shortly after the initial exams have been completed. The physical training protocol will consist of a 12-week duration, with a frequency of 3 weekly sessions of 60 minutes duration each. The intensity will be prescribed from the echocardiogram with effort and cardiopulmonary test. All sessions will be monitored by telemetry and will be distributed as follows:

  • 5 minutes warm up
  • 30 to 40 minutes of aerobic exercise (treadmill). The training intensity will be prescribed individually, based on the results of the test results;
  • 10 minutes of localized exercises;
  • 5 minutes of relaxation.

Primary outcomes

  1. Cardiovascular rehabilitation in patients with refractory angina is safe;

    Time frame: 3 months of rehabilitation

    Evaluated number of patients who have any kind of cardiovascular event during rehabilitation, as well as number of sore throat during the sessions.

  2. Cardiovascular rehabilitation in patients with refractory angina is efficient;

    Time frame: 3 months of rehabilitation

    Evaluated number of sore throat during the sessions.

  3. Improve the maximal oxygen consumption

    Time frame: 3 months of rehabilitation

    Improvement of Maximal oxygen uptake (VO2max)

  4. Improve the global myocardial ischemic load

    Time frame: 3 months of rehabilitation

    Reduction of myocardial ischemia, evidenced by improvement of the standard by effort echocardiography

Secondary outcomes

  1. Reduction of myocardial injury caused by physical stress

    Time frame: 3 months of rehabilitation

    Improves levels of Troponin-T after 1 exercise session at the initial moment of the Protocol and after 3 months.

  2. Rehabilitation will modulate sympathetic activity

    Time frame: 3 months of rehabilitation

    Decreased sympathetic nerve activity measured by the amount of shots in his microneurography

  3. Improvement of ventricular function

    Time frame: 3 months of rehabilitation

    Improvement of ventricular function through stress echocardiography in patients undergoing rehabilitation

  4. Improvement of the quality of life

    Time frame: 3 months of rehabilitation

    Improvement of the quality of life measured through the SF-36 questionnaire.

  5. Rehabilitation will increase muscle blood flow

    Time frame: 3 months of rehabilitation

    Increase peripheral muscle blood flow measured by plethysmography.

  6. Reduction in the number of symptomatic episodes of ischemia

    Time frame: 3 months of rehabilitation

    Reduction in the number of episodes of ischemia, reduction of daily sublingual nitrate intake.

  7. Reduction of the daily consumption of sublingual nitrate

    Time frame: 3 months of rehabilitation

    Reduction of daily sublingual nitrate intake.

  8. Improve the functional class of Refractory Angina

    Time frame: 3 months of rehabilitation

    Improve the functional class decrease of angina (according to Canadian Cardiovascular Society classification)

Sponsors and collaborators

Lead sponsor

Hospital Israelita Albert Einstein

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo
  • Instituto do Coracao

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2022
First posted
Jul 17, 2017
Registry last updated
Feb 11, 2022

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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