Clinical trial NCT03476590: New Model of Care in Heart Failure
Official title: A New Model of Medical Care With Use of Modern Methods of Non-invasive Clinical Assessment and Telemedicine in Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: heart failure
ambulatory care
telemedicine
impedance cardiography
Lead sponsor: Military Institute od Medicine National Research Institute
Sponsor class: OTHER
Collaborators: name: Wroclaw Medical University
name: 4th Military Clinical Hospital with Polyclinic, Poland
name: Medical University of Gdansk
name: Military University of Technology
First posted: 2018-03-26
Enrollment: 605
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, randomized (1:1), open-label and controlled, parallel group study
Primary purpose: TREATMENT

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 solutions that enable effective monitoring and assessment of HF patients' clinical status become priority in treatment strategy. The applicant proposes to develop a model of care for HF patients based on modern non-invasive diagnostic tools and telemedicine. Clinical evaluation will be based on i.e. impedance cardiography, a simple non-invasive method of hemodynamic monitoring, including assessment of heart rate, blood pressure, left ventricular stroke volume, chest and total fluid status. The telemedicine system will enable rapid, appropriate to the patient's clinical status, therapeutic decision undertaken remotely by specialist. Implementation of the proposed model of care will contribute to a significant improvement in prognosis of HF patients (through i.e. improved access to specialist consultation, the early diagnosis of the deterioration of HF and the optimization of treatment). The significant economic, social and scientific benefits related to the project are also expected.

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 morbidity and mortality rate, poor quality of life and frequent hospitalizations. Along with the medicine progress, in particular in the scope of acute coronary syndromes treatment, the number of HF patients is constantly growing. The essential problem connected with HF is its progress course and an increasing rate of subsequent hospitalizations (approximately 30% of hospitalizations are the repeated ones). It is estimated that the costs of hospital stays constitute nearly 2/3 of healthcare costs provided for HF patients.

It has been estimated that the prevalence of HF will increase by 25% and its direct costs by 215% in the next 20 years. The prognosis in HF is closely connected with the progression of the disease defined in accordance with the NYHA (New York Heart Association) functional classification. The yearly mortality rate among each NYHA class is: class 1 - up to 10%, class 2 - 10-20%, class 3 - 20-40%, class 4 - mortality 40-60%. Over a half of the patients with symptomatic HF die within 4 years of observation.

In the AMULET study we we will merging the interventions that so far turned out to be effective (specialist counselling, phone counselling programmes and telemonitoring). Therefore, we created of ambulatory care points for HF patients, which would be equipped with diagnostic devices (impedance cardiography and body composition analyser (bioimpedance scale)), assessing the most important clinical parameters. Ambulatory care point will be operated by a trained nurse, under a telemetry supervision of a specialist.

The following parameters were identified as the indicators of treatment effects: heart rate (HR), systolic and diastolic blood pressure (SBP and DBP), thoracic fluid content (TFC) and its change (delta TFC), change of body mass and total body water (delta TBW).

The telemedicine solutions will strongly support the proposed system. The clinical data will be automatically entered into an interactive system (database), which will send information to a supervising cardiologist, in accordance with the previously implemented recommendation support module (RSM). Regarding RSM indications remote specialist recommendation will be generated (e.g. maintenance or modification of treatment, referral to hospital).

The proposed approach will satisfy ESC recommendations on long-term management: plan follow-up strategy (including plan to up-titrate/optimize dose of disease-modifying drugs); improvement in symptoms, quality of life and survival; prevention of readmissions; management programme; education and appropriate lifestyle adjustments.

Eligibility criteria: Inclusion Criteria:

1. age \>18 years;
2. 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:

1. cardiogenic shock
2. myocardial (STE-ACS/NSTE-ACS) infarct as the main cause of hospitalization within the last 40 days prior to recruitment;
3. stroke within 40 days prior to recruitment;
4. cardiac surgery within 90 days prior to recruitment;
5. elective cardiac surgery (or any other high risk surgery) within next 90 days;
6. pulmonary embolism within 40 days prior to recruitment;
7. severe pulmonary diseases, including: chronic obstructive pulmonary disease (stage C/D), uncontrolled asthma, pulmonary hypertension (WHO class III-IV);
8. chronic kidney disease (stage 5 and/or requiring dialysis);
9. severe inflammatory disease, including: pneumonia as the main cause of hospitalization; sepsis; tuberculosis;
10. severe mental and physical disorders;
11. life expectancy less than 12 months in the opinion of the physician because of reasons other than HF;
12. 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).
13. pregnancy;
14. patients' refusal to participate.

Primary outcomes:
measure: cardiovascular death and/or hospitalization for worsening heart failure (HF).
timeFrame: 12 months
Secondary outcomes:
measure: cardiovascular death
timeFrame: 12 months
measure: death due to worsening of HF
timeFrame: 12 months
measure: all-cause death
timeFrame: 12 months
measure: hospitalization for worsening HF
timeFrame: 12 months
measure: cardiovascular hospitalization
timeFrame: 12 months
measure: all-cause hospitalization
timeFrame: 12 months
measure: number of hospitalizations for worsening HF per patient during 12 months of follow-up
timeFrame: 12 months
measure: days lost due to unplanned HF hospitalisation(s) or all-cause mortality
timeFrame: 12 months
Other outcomes:
measure: time to first hospitalization for any reason
timeFrame: 12 months
measure: time to first hospitalization for any cardiovascular reason
timeFrame: 12 months
measure: time to first hospitalization due to worsening HF
timeFrame: 12 months
measure: time to death for any reason
timeFrame: 12 months
measure: time to death for any cardiovascular reason
timeFrame: 12 months
measure: time to death due to worsening HF
timeFrame: 12 months
measure: SF-36 score at 12 months adjusted for baseline
timeFrame: 12 months
measure: Minnesota Questionnaire score at 12 months adjusted for baseline
timeFrame: 12 months
measure: NYHA functional class at 12 months adjusted for baseline
timeFrame: 12 months
measure: final (12 month) daily doses (% of guidelines required target dose) of the following medicaments: ACEI, ARB, beta-blocker, MRA, ARNI
timeFrame: 12 months
measure: final (12 month) doses (mg) of the diuretics (furosemide, torasemide, hydrochlorotiazide, indapamid)
timeFrame: 12 months
Locations:
city: Warsaw
country: Poland
facility: Military Institute of Medicine
state: Mazovia
Study officials:
References:
citation: Krzesinski P, Siebert J, Jankowska EA, Banasiak W, Piotrowicz K, Stanczyk A, Galas A, Walczak A, Murawski P, Chrom P, Gutknecht P, Siwolowski P, Ponikowski P, Gielerak G. Rationale and design of the AMULET study: A new Model of telemedical care in patients with heart failure. ESC Heart Fail. 2021 Aug;8(4):2569-2579. doi: 10.1002/ehf2.13330. Epub 2021 Apr 22.