Heart FailureAMULETNCT03476590
New Model of Care in Heart Failure
A study testing new model of ambulatory care with use of of non-invasive vital signs assessment and telemedicine in people with Heart Failure, run by Military Institute od Medicine National Research Institute at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- new model of ambulatory care with use of of non-invasive vital signs assessment and telemedicine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 605 participants
- Where
- 1 sitePoland
- Study dates
- 5 Mar 2018to 30 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Military Institute of Medicine
Warsaw, Masovian Voivodeship, 04-141
About this study
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
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- new model of ambulatory care with use of of non-invasive vital signs assessment and telemedicine
- Keywords
- heart failure, ambulatory care, telemedicine, impedance cardiography
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
new model of ambulatory care with use of of non-invasive vital signs assessment and telemedicineProcedure or surgery
Also called Patient's tailored ambulatory care based on remote telemonitoring
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.
| Study group | Role | What they receive |
|---|---|---|
| standard care | No intervention | 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) |
| intervention group | Experimental | 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. Receives: Procedure: new model of ambulatory care with use of of non-invasive vital signs assessment and telemedicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiovascular death and/or hospitalization for worsening heart failure (HF).
Measured: 12 months
Secondary outcomes (8)
cardiovascular death
Measured: 12 months
death due to worsening of HF
Measured: 12 months
all-cause death
Measured: 12 months
hospitalization for worsening HF
Measured: 12 months
cardiovascular hospitalization
Measured: 12 months
all-cause hospitalization
Measured: 12 months
number of hospitalizations for worsening HF per patient during 12 months of follow-up
Measured: 12 months
days lost due to unplanned HF hospitalisation(s) or all-cause mortality
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start5 Mar 2018
- Primary completion31 Oct 2020
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, randomized (1:1), open-label and controlled, parallel group study
- Masking
- None (open label)
- Enrolment
- 605 participants (actual)
Sponsor and investigators
- Lead sponsor
- Military Institute od Medicine National Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Wroclaw Medical University, 4th Military Clinical Hospital with Polyclinic, Poland, Medical University of Gdansk, Military University of Technology
- Responsible party
- Principal investigator, Paweł Krzesiński, Military Institute od Medicine National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03476590
- Sponsor's protocol ID
- STRATEGMED3/305274/8/NCBR/2017
- Acronym
- AMULET
- Status last verified
- Mar 2023
- First submitted
- 17 Mar 2018
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Piotrowicz K, Krzesinski P, Galas A, Stanczyk A, Siebert J, Jankowska EA, Siwolowski P, Gutknecht P, Murawski P, Szalewska D, Banasiak W, Ponikowski P, Gielerak G. Health-related quality of life and self-care in heart failure patients under telecare-insights from the randomized, prospective, controlled AMULET trial. Front Public Health. 2024 Sep 25;12:1431778. doi: 10.3389/fpubh.2024.1431778. eCollection 2024.
PubMed 39391161Krzesinski 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.
PubMed 33887120
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03476590
- Acronym / sponsor ID
- AMULET / STRATEGMED3/305274/8/NCBR/2017
- Conditions
- Heart Failure
- Keywords
- heart failure, ambulatory care, telemedicine, impedance cardiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 605 participants (actual)
- Lead sponsor
- Military Institute od Medicine National Research InstituteUniversity, hospital or other
- Collaborators
- Wroclaw Medical University, 4th Military Clinical Hospital with Polyclinic, Poland, Medical University of Gdansk, Military University of Technology
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 26 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective, randomized (1:1), open-label and controlled, parallel group study
| Arm | Type | Receives |
|---|---|---|
| standard care | No intervention | –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) |
| intervention group | Experimental | Procedure: new model of ambulatory care with use of of non-invasive vital signs assessment and telemedicineIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| new model of ambulatory care with use of of non-invasive vital signs assessment and telemedicineAlso: Patient's tailored ambulatory care based on remote telemonitoringThe 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. | Procedure or surgery | intervention group |
Primary outcome
cardiovascular death and/or hospitalization for worsening heart failure (HF).
Time frame: 12 months
8 secondary outcomes
cardiovascular death
Time frame: 12 months
death due to worsening of HF
Time frame: 12 months
all-cause death
Time frame: 12 months
hospitalization for worsening HF
Time frame: 12 months
cardiovascular hospitalization
Time frame: 12 months
all-cause hospitalization
Time frame: 12 months
number of hospitalizations for worsening HF per patient during 12 months of follow-up
Time frame: 12 months
days lost due to unplanned HF hospitalisation(s) or all-cause mortality
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Derived from this study: PubMed 39391161Piotrowicz K, Krzesinski P, Galas A, Stanczyk A, Siebert J, Jankowska EA, Siwolowski P, Gutknecht P, Murawski P, Szalewska D, Banasiak W, Ponikowski P, Gielerak G. Health-related quality of life and self-care in heart failure patients under telecare-insights from the randomized, prospective, controlled AMULET trial. Front Public Health. 2024 Sep 25;12:1431778. doi: 10.3389/fpubh.2024.1431778. eCollection 2024.
- Derived from this study: PubMed 33887120Krzesinski 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing new model of ambulatory care with use of of non-invasive vital signs assessment and telemedicine in people with Heart Failure, run by Military Institute od Medicine National Research Institute at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiovascular death and/or hospitalization for worsening heart failure (HF). (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03476590, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.