Status:
COMPLETED
New Model of Care in Heart Failure
Lead Sponsor:
Military Institute od Medicine National Research Institute
Collaborating Sponsors:
Wroclaw Medical University
4th Military Clinical Hospital with Polyclinic, Poland
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Heart failure (HF) is characterized by high mortality, poor quality of life and frequent hospitalizations. The effectiveness of out-patient care for HF patients is unsatisfactory. Therefore the soluti...
Detailed Description
Treatment of patients with heart failure (HF) is a great challenge for contemporary medicine. HF frequency in European population is assessed for 0.4-2%. This disease is characterized by high morbidit...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2021
Estimated Enrollment :
605 Patients enrolled
Trial Details
Trial ID
NCT03476590
Start Date
March 5 2018
End Date
March 30 2021
Last Update
March 15 2023
Active Locations (1)
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1
Military Institute of Medicine
Warsaw, Masovian Voivodeship, Poland, 04-141