Clinical trial NCT03218891: Cardiac Rehabilitation in Patients With Refractory Angina
Official title: Cardiac Rehabilitation in Patients With Refractory Angina
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractory Angina
Keywords: Refractory Angina
Rehabilitation
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
name: Instituto do Coracao
First posted: 2017-07-17
Enrollment: 72
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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);
4. Group normal healthy subjects
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cardiovascular rehabilitation in patients with refractory angina is safe;
timeFrame: 3 months of rehabilitation
measure: Cardiovascular rehabilitation in patients with refractory angina is efficient;
timeFrame: 3 months of rehabilitation
measure: Improve the maximal oxygen consumption
timeFrame: 3 months of rehabilitation
measure: Improve the global myocardial ischemic load
timeFrame: 3 months of rehabilitation
Secondary outcomes:
measure: Reduction of myocardial injury caused by physical stress
timeFrame: 3 months of rehabilitation
measure: Rehabilitation will modulate sympathetic activity
timeFrame: 3 months of rehabilitation
measure: Improvement of ventricular function
timeFrame: 3 months of rehabilitation
measure: Improvement of the quality of life
timeFrame: 3 months of rehabilitation
measure: Rehabilitation will increase muscle blood flow
timeFrame: 3 months of rehabilitation
measure: Reduction in the number of symptomatic episodes of ischemia
timeFrame: 3 months of rehabilitation
measure: Reduction of the daily consumption of sublingual nitrate
timeFrame: 3 months of rehabilitation
measure: Improve the functional class of Refractory Angina
timeFrame: 3 months of rehabilitation
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto Israelita de Ensino e Pesquisa Albert Einstein 's (IIEP)
Study officials:
affiliation: Hospital Israelita Albert Einstein
name: Luciana Janot de Matos, Dra
role: PRINCIPAL_INVESTIGATOR
affiliation: InCor Heart Institute
name: Luciana Janot de Matos, Dra
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Assumpcao CRA, do Prado DML, Jordao CP, Dourado LOC, Vieira MLC, Montenegro CGSP, Negrao CE, Gowdak LHW, De Matos LDNJ. Cardiopulmonary exercise test in patients with refractory angina: functional and ischemic evaluation. Clinics (Sao Paulo). 2022 Feb 5;77:100003. doi: 10.1016/j.clinsp.2021.100003. eCollection 2022.