Chronic Heart Failure Clinical Trial
— RegenHeartOfficial title:
Optimization of the Complex Treatment of Nonischemic Dilated Cardiomyopathy Due to the Addition to the Standard Drug Therapy of Intracoronary Administration of Umbilical Cord-derived Mesenchymal Stromal Cells
Verified date | April 2023 |
Source | The Research-Clinical Center for Cardiac Surgery and Transplantology LLP |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to optimize the complex treatment of chronic heart failure of non-ischemic etiology by supplementing umbilical cord mesenchymal stem cells to the standard drug therapy.
Status | Completed |
Enrollment | 30 |
Est. completion date | April 1, 2023 |
Est. primary completion date | January 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Men and women over 18 years of age, who are registered in the dispensary at the The Research-Clinical Center for Cardiac Surgery and Transplantology; - The previously established clinical diagnosis of Dilated cardiomyopathy in the stage III-IV of New York Heart Association classification; - Non-ischemic etiology of Dilated cardiomyopathy according to coronary angiography or computed tomography of the heart with contrast; - Decreased contractile function of the heart the left ventricular ejection fraction =35% according to transthoracic echocardiography and computed tomography of the heart with contrast; - Presence of automatic (implantable) cardiac defibrillator; - Lack of laboratory and clinical data on dysfunctions or insufficiency of other internal organs; - The absence of a history of cancer over the past 5 years and deviations according to the analysis of tumor markers; - Signed voluntary informed consent to participate in the study. Exclusion Criteria: - Coronary artery disease, previously undergone cardiac surgery, including stenting of the coronary arteries; - The presence of clinically significant valve pathology, blood clots in the cavities of the heart, aneurysms of the left ventricle, hypertrophic, early postpartum, alcoholic or restrictive cardiomyopathy, congenital heart defects and resistant hypertension; - A history of stroke in the past 2 years; - A history of autoimmune and immunodeficiency diseases; - Polyvalent allergy; - Decompensation of concomitant chronic diseases; - Reception of systemic corticosteroids, cytostatics, immunosuppressive drug therapy (cyclophosphamide, methotrexate, cyclosporine, azathioprine, etc.), as well as drugs that deplete DNA or cytotoxic drugs, the last intake of which was within four weeks before the study; - Hepatitis B and / or C, syphilis, HIV-carriage or AIDS; - The presence of acute systemic infections requiring targeted antibiotic therapy; - A history of untreated peptic ulcer and bleeding from the gastrointestinal tract; - The presence of early transferred closed and open craniocerebral injuries that have a clinical manifestation and require specialized treatment; - A history of uncontrolled epileptic seizures; - Porphyria; - The need for hospitalization and treatment in a hospice; - Alcohol and drug abuse, lack of permanent residence, severe depression, disorientation, distant living. |
Country | Name | City | State |
---|---|---|---|
Kazakhstan | The Research-Clinical Center for Cardiac Surgery and Transplantology LLP | Taraz | Zhambyl |
Lead Sponsor | Collaborator |
---|---|
The Research-Clinical Center for Cardiac Surgery and Transplantology LLP | State-Financed Health Facility "Samara Regional Medical Center Dinasty" |
Kazakhstan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change in the contractile function of the heart | changes in the ejection fraction of the right and left ventricles evaluated by transthoracic echocardiography and computed tomography | 1,3,6 months | |
Primary | change in the size of the heart | changes in the size of the right and left atrium, end diastolic and end systolic size of the right and left ventricles evaluated by transthoracic echocardiography and computed tomography | 1,3,6 months | |
Primary | change in the volumes of the heart | changes in the volumes of the right and left atrium, end diastolic and end systolic volumes of the right and left ventricles evaluated by transthoracic echocardiography and computed tomography | 1,3,6 months | |
Secondary | change in the clinical condition evaluated by the Scale for Heart failure to Optimize Clinical Status | changes in the clinical condition evaluated by the Scale for Heart failure to Optimize Clinical Status (SHOCS). The SHOCS scale consists of 10 points. The maximum possible score is 20, and the minimum is 0. Higher scores indicate a worse or worsening clinical condition, while lower scores or decreasing scores indicate a better clinical condition. | 1,3,6 months | |
Secondary | change in the markers of myocardial dysfunction | changes in the markers of myocardial dysfunction of the serum level of amino-terminal pro-brain natriuretic peptide | 1, 3 and 6 months | |
Secondary | change in the in the 6-minute walk test | changes in the 6-minute walk test, defined as the changes in the distance of traveled | 1, 3 and 6 months | |
Secondary | change in the functional status | change in the functional status according to the New York Heart Association classification | 1, 3 and 6 months | |
Secondary | change in the quality of life evaluated by the questionnaire Short Form 12 Healthy Survey | change in the quality of life evaluated by the questionnaire Short Form 12 Healthy Survey (SF-12). The SF 12 questionnaire consists of 12 items. The low level of the quality of life corresponds to estimates of 36-47 points, average of 24-35 points, high of 12-23 points. | 1, 3 and 6 months | |
Secondary | change in the quality of life evaluated by the Kansas City Cardiomyopathy Questionnaire | changes in the quality of life evaluated by the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ is composed of 23 items. The options for the answers are of 1 to 5, 6 or 7 points and the score of each of its dimensions has a theoretical range from 0 to 100, 100 being the best outcome. | 1, 3 and 6 months | |
Secondary | change in the quality of life evaluated by the Minnesota Living with Heart Failure Questionnaire | changes in the quality of life evaluated by the Minnesota Living with Heart Failure (MLHF) Questionnaire. The MLHF questionnaire is composed of 21 items. The maximum possible scores being 105 and the minimum 0. Higher scores indicate a worse or worsening quality of life, while lower scores or decreasing scores indicate a better quality of life. | 1, 3 and 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03597646 -
The Effect of Kinesio Taping on Pulmonary Function and Functional Capacity in Patients With Chronic Heart Failure
|
N/A | |
Terminated |
NCT04065997 -
Apogee International
|
||
Withdrawn |
NCT03675113 -
Effect of Upper Extremity Aerobic Exercise Training on Exercise Capacity Patients With Chronic Heart Failure
|
N/A | |
Completed |
NCT02916160 -
Sacubitril-valsartan and Heart Failure Patients : the ENTRESTO-SAS Study
|
Phase 4 | |
Completed |
NCT03126656 -
Effects of Testosterone on Myocardial Repolarization
|
Phase 4 | |
Completed |
NCT02268500 -
VAccination to Improve Clinical outComes in Heart Failure Trial: a Feasibility Study (VACC-HeFT)
|
Phase 4 | |
Completed |
NCT02247245 -
The Influence of Heart Rate Limitation on Exercise Tolerance in Pacemaker Patients.
|
N/A | |
Terminated |
NCT01906957 -
Cognition and Exercise Training
|
N/A | |
Completed |
NCT01919918 -
Muscle Afferent Feedback Effects in Patients With Heart Failure
|
Phase 1 | |
Not yet recruiting |
NCT01669395 -
Severe Heart Failure and Homebased Rehabilitation - An Intersectoral Randomized Controlled Trial
|
N/A | |
Completed |
NCT00984529 -
Evaluation of Clinical Signs and Symptoms of Chronic Heart Failure in Patients Treated With Candesartan Cilexetil in Croatia
|
N/A | |
Recruiting |
NCT00863421 -
Sleep Disordered Breathing in Patients With Chronic Heart Failure
|
N/A | |
Completed |
NCT02840565 -
Tolerability, Pharmacokinetics and Pharmacodynamics of Six Multiple Rising Dose Regimens of BIA 5-453
|
Phase 1 | |
Completed |
NCT02441218 -
Effects of Ivabradine on Cardiovascular Events in Patients With Moderate to Severe Chronic Heart Failure and Left Ventricular Systolic Dysfunction. A Three-year International Multicentre Study
|
Phase 3 | |
Completed |
NCT00149409 -
Omega-3-Polyunsaturated Fatty-Acids (N3-Pufa) In Patients With Severe Chronic Heart Failure
|
Phase 2/Phase 3 | |
Terminated |
NCT05532046 -
A Study to Learn How Safe Study Drug BAY2413555 is, How it Affects the Body, and How it Moves Into, Through, and Out of the Body Over 4 Weeks of Use in Participants With Heart Failure and Implanted Cardiac Defibrillator or Cardiac Resynchronization Devices (ICD/CRT)
|
Phase 1 | |
Recruiting |
NCT04984928 -
Readmission Risk of Patients With Heart Failure.
|
||
Completed |
NCT02814097 -
A Study to Evaluate the Effects of 4 Weeks Treatment With Subcutaneous Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Preserved Ejection Fraction
|
Phase 2 | |
Active, not recruiting |
NCT05560737 -
ODYSSEE-vCHAT Mental Health Program for Heart Failure and Kidney Disease Patients
|
||
Recruiting |
NCT03286127 -
Palliative Outcome Evaluation Muenster I
|