New Model of Care in Heart Failure

Heart Failure Clinical Trial

— AMULET  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03476590
• Other study ID #: STRATEGMED3/305274/8/NCBR/2017
• Status: Completed
• Phase: N/A
• Start date: March 5, 2018
• Est. completion date: March 30, 2021

Study information

• Verified date: March 2023
• Source: Military Institute of Medicine, Poland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 605
• Est. completion date: March 30, 2021
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Procedure:
• new model of ambulatory care with use of of non-invasive vital signs assessment and telemedicine
The report of symptoms and physical examination will be obligatory performed by the ACP nurse. Self-condition and quality of life assessment at every visit will be based on EQ-5D questionnaire and VAS 10-points scale Hemodynamic assessment - the ACP nurse will perform impedance cardiography (cardiomonitor) and bioimpedance (scale). The parameters measured by ICG and bioimpedance will be assessed with respect to individually defined target values for: 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). Supervising physician will confront ICG/bioimpedance results with the patient's clinical data and give final remote recommendations.

Locations

Country	Name	City	State
Poland	Military Institute of Medicine	Warsaw	Mazovia

Sponsors (5)

Lead Sponsor	Collaborator
Military Institute of Medicine, Poland	4th Military Hospital, Medical University of Gdansk, Military University of Technology, Wroclaw Medical University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	time to first hospitalization for any reason		12 months
Other	time to first hospitalization for any cardiovascular reason		12 months
Other	time to first hospitalization due to worsening HF		12 months
Other	time to death for any reason		12 months
Other	time to death for any cardiovascular reason		12 months
Other	time to death due to worsening HF		12 months
Other	SF-36 score at 12 months adjusted for baseline		12 months
Other	Minnesota Questionnaire score at 12 months adjusted for baseline		12 months
Other	NYHA functional class at 12 months adjusted for baseline		12 months
Other	final (12 month) daily doses (% of guidelines required target dose) of the following medicaments: ACEI, ARB, beta-blocker, MRA, ARNI		12 months
Other	final (12 month) doses (mg) of the diuretics (furosemide, torasemide, hydrochlorotiazide, indapamid)		12 months
Primary	cardiovascular death and/or hospitalization for worsening heart failure (HF).		12 months
Secondary	cardiovascular death		12 months
Secondary	death due to worsening of HF		12 months
Secondary	all-cause death		12 months
Secondary	hospitalization for worsening HF		12 months
Secondary	cardiovascular hospitalization		12 months
Secondary	all-cause hospitalization		12 months
Secondary	number of hospitalizations for worsening HF per patient during 12 months of follow-up		12 months
Secondary	days lost due to unplanned HF hospitalisation(s) or all-cause mortality		12 months