New Model of Care in Heart Failure (AMULET)
Heart Failure
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring heart failure, ambulatory care, telemedicine, impedance cardiography
Eligibility Criteria
Inclusion Criteria:
- age >18 years;
- HF with LVEF≤49% and at least 1 hospitalization due to the acute HF decompensation (with clinical presentation in NYHA class III-IV) within the last 6 months before enrollment.
Exclusion Criteria:
- cardiogenic shock
- myocardial (STE-ACS/NSTE-ACS) infarct as the main cause of hospitalization within the last 40 days prior to recruitment;
- stroke within 40 days prior to recruitment;
- cardiac surgery within 90 days prior to recruitment;
- elective cardiac surgery (or any other high risk surgery) within next 90 days;
- pulmonary embolism within 40 days prior to recruitment;
- severe pulmonary diseases, including: chronic obstructive pulmonary disease (stage C/D), uncontrolled asthma, pulmonary hypertension (WHO class III-IV);
- chronic kidney disease (stage 5 and/or requiring dialysis);
- severe inflammatory disease, including: pneumonia as the main cause of hospitalization; sepsis; tuberculosis;
- severe mental and physical disorders;
- life expectancy less than 12 months in the opinion of the physician because of reasons other than HF;
- patient currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study (ies), or subject is receiving other investigational agent(s).
- pregnancy;
- patients' refusal to participate.
Sites / Locations
- Military Institute of Medicine
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
standard care
intervention group
In standard care group the patients will be recommended to visit physician/cardiologists in standard healthcare system. Two non-interventional visits will be performed: recruitment visit (day of enrolment) and summary visit (12th month after the enrolment)
In intervention group patients will be referred to ambulatory care point (ACP) and the physicians will perform remote teleconsultations. The visits will be realized by nurses supported with vital sign assessment based on bioimpedance diagnostic methods (impedance cardiography, bioimpedance scale). The ambulatory visits will be performed according to the schedule: (1') recruitment visit (1st day of enrolment) performed by physician -> 7 ambulatory visits: (1) 1st day of enrolment (performed by nurse and physician), (2) 7th-10th day (performed by nurse and physician), (3) 1st month, (4) 3th month, (5) 6th month, (6) 9th month, (7) 12th month after the enrolment (visits no 3-7 performed by nurse with tele-supervision by physician) and -> (7') summary visit (12th month after the enrolment) performed by physician. The plan of visits may be modified if required by the clinical status change, i.e. deterioration of clinical parameters and interim hospitalizations for worsening heart failure.