AMULET – Initiating a randomised, prospective, controlled clinical trial of AMULET (Task 3)

At the beginning of March 2018, the first patients were enrolled on the randomised, prospective and controlled AMULET clinical trial, which will evaluate the clinical effectiveness of the care model developed in the pilot study. The telecare of patients will use modern diagnostic methods and a multifunctional electronic platform that was created through the cooperation of teams of medics and IT specialists of the Military Medical Institute and the Military University of Technology.

The study is designed for patients with heart failure with left ventricular ejection fraction (LVEF) ≤49% and at least one hospitalisation for its exacerbation in the 6 months prior to inclusion (with clinical presentation in NYHA class III-IV).

Exclusion criteria include:

  • Cardiogenic shock;
  • Acute coronary syndrome (ST elevation/non-ST elevation myocardial infarction) as the main cause of hospitalisation within the 40 days prior to enrolment;
  • Stroke within the 40 days prior to enrolment;
  • Cardiac surgery within the 90 days prior to enrolment;
  • High-risk cardiac or non-cardiac surgery planned within the next 90 days after enrolment;
  • An episode of pulmonary embolism within the 40 days prior to enrolment;
  • Severe lung disease, including chronic obstructive pulmonary disease (stage C/D),
  • Uncontrolled bronchial asthma,
  • Pulmonary hypertension (WHO class III-IV);
  • Chronic kidney disease (stage 5 and/or renal replacement therapy).

All patients will be assessed by a cardiologist at least twice – on the day of inclusion in the study and after one year of follow-up. Half of the patients, randomly assigned to the intervention group, will additionally attend regular visits to the so-called ambulatory care point, where a nurse will examine the patient, perform additional state-of-the-art tests to assess cardiovascular parameters and enter the results into the telemedicine platform. Based on that, the cardiologist supervising the visit makes therapeutic recommendations, which will be given to the patient in writing.

The study is carried out by nine centres across Poland, ranging from municipal specialist clinics to outpatient clinics.