Heart Failure Clinical Trial
— AEROFIT-HFOfficial title:
Effectiveness and Safety of Complex Exercises of the Respiratory Muscles Plus Aerobic Training vs. Aerobic Training in Patients With CHF and II-IV NYHA FC: Prospective Randomized Clinical Trial With Sham Control
The aim of the study is to test the hypothesis that the physical rehabilitation starting with respiratory training followed by the aerobic exercises will have a more pronounced effect on clinical and functional indicators than the currently used physical rehabilitation based on aerobic training alone
Status | Completed |
Enrollment | 20 |
Est. completion date | December 30, 2020 |
Est. primary completion date | December 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: - Male and female patients aged 18 years and older (inclusive) - Patients with stable heart failure of the II-III functional class. - Signed patient informed consent to participate in the study. - Left ventricular ejection fraction =40%, confirmed by the results of EchoCG no more than 3 months before the start of the study. - Patients who can understand the objectives of this study and comply with the requirements of the Protocol. Exclusion Criteria: - • Heart failure I and VI functional class - Left ventricular ejection fraction> 41% or no confirmed data on the left ventricular EF. - Myocardial infarction, ACS, heart surgery, percutaneous coronary intervention, or coronary artery bypass surgery performed less than 3 months prior to randomization. - Unstable or refractory angina. - Pulmonary heart. - Constrictive pericarditis. - Hypertrophic cardiomyopathy. - Amyloid cardiomyopathy. - Syndrome of premature excitation of the ventricles. - The need for percutaneous coronary intervention or coronary bypass surgery in the near future. - Sinus node dysfunction syndrome. - The presence of a pacemaker. - The presence of diagnosed non-cardiac causes of CHF. - Any non-cardiac disease that reduces the expected duration to less than 2 years from the moment of randomization. - A stroke less than 1 month prior to randomization or a stroke with marked continuing neurological disorders less than 12 months before randomization - Orthopedic disorders that prevent physical training - COPD, Bronchial asthma. Another lung disease that can affect CSTP results - Significant impaired renal function (plasma creatinine 220 µmol / L or higher). - Significant abnormal liver function (increased ALT or AST more than 3 times relative to the upper limit of normal). - Acute coronary syndrome less than 3 months before randomization. - Obstructive or restrictive cardiomyopathy. - Acute myocarditis. - Hemodynamically significant organic lesions of valves requiring surgical intervention. - A history of heart transplantation or current waiting for a heart transplant. - Drug addiction, substance abuse, alcoholism, drug use in history. - Mental, physical and other reasons that do not allow to adequately assess their behavior and correctly fulfill the conditions of the study protocol. - A history of any significant, in the opinion of the physician-researcher, condition / disease or circumstances that prevent the inclusion in the study. - Inability / reluctance of the patient to provide signed informed consent to participate in the study. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Julia Begrambekova | Moscow | Moscow Region |
Lead Sponsor | Collaborator |
---|---|
Lomonosov Moscow State University Medical Research and Educational Center | Russian Heart Failure Society |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in health-related quality of life | Minnesota Living with Heart Failure Questionnaire/ The quality of life between study groups and the change in quality of life over time between study groups. | 4 weeks | |
Other | Change in health-related quality of life | Minnesota Living with Heart Failure Questionnaire. Assessed from baseline visit to 16 weeks follow-up visit.The quality of life between study groups and the change in quality of life over time between study groups using clinically accepted quality of life measures. MLHFQ | 16 weeks | |
Other | Anxiety and Depression | Hospital Anxiety sand Depression Scale (HADS) The questionnaire comprises seven questions for anxiety and seven questions for depression.Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21. The cut off for both scales in 11. | 4 weeks | |
Other | Anxiety and Depression | Hospital Anxiety sand Depression Scale (HADS) The questionnaire comprises seven questions for anxiety and seven questions for depression.Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21. The cut off for both scales in 11. | 16 weeks | |
Primary | Functional Capacity | Change in Peak VO2 | 16 weeks | |
Secondary | proBNP | Change in concentration of NT- proBNP from baseline | 4 weeks | |
Secondary | proBNP | Change in concentration of NT- proBNP from baseline | 16 weeks | |
Secondary | Respiratory muscle strength | Change in maximal inspiratory and expiratory pressures (PImax and PEmax) from baseline | 4 weeks | |
Secondary | Respiratory muscle strength | Change in maximal inspiratory and expiratory pressures (PImax and PEmax) from baseline | 16 weeks | |
Secondary | Neurohormone activity | Difference between Active and Control groups in Angiotensin II (A II) concentration from baseline | 4 weeks | |
Secondary | Neurohormone activity | Change in concentration of Angiotensin II (A II) from baseline | 16 weeks |
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