New Model of Care in Heart Failure (AMULET)

March 13, 2023 updated by: Paweł Krzesiński, Military Institute of Medicine, Poland

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
605

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Mazovia
      • Warsaw, Mazovia, Poland, 04-141
        • Military Institute of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: standard care
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)
Experimental: intervention group

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.
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.

Other Names:
  • Patient's tailored ambulatory care based on remote telemonitoring

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
cardiovascular death and/or hospitalization for worsening heart failure (HF).
Time Frame: 12 months
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
cardiovascular death
Time Frame: 12 months
12 months
death due to worsening of HF
Time Frame: 12 months
12 months
all-cause death
Time Frame: 12 months
12 months
hospitalization for worsening HF
Time Frame: 12 months
12 months
cardiovascular hospitalization
Time Frame: 12 months
12 months
all-cause hospitalization
Time Frame: 12 months
12 months
number of hospitalizations for worsening HF per patient during 12 months of follow-up
Time Frame: 12 months
12 months
days lost due to unplanned HF hospitalisation(s) or all-cause mortality
Time Frame: 12 months
12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
time to first hospitalization for any reason
Time Frame: 12 months
12 months
time to first hospitalization for any cardiovascular reason
Time Frame: 12 months
12 months
time to first hospitalization due to worsening HF
Time Frame: 12 months
12 months
time to death for any reason
Time Frame: 12 months
12 months
time to death for any cardiovascular reason
Time Frame: 12 months
12 months
time to death due to worsening HF
Time Frame: 12 months
12 months
SF-36 score at 12 months adjusted for baseline
Time Frame: 12 months
12 months
Minnesota Questionnaire score at 12 months adjusted for baseline
Time Frame: 12 months
12 months
NYHA functional class at 12 months adjusted for baseline
Time Frame: 12 months
12 months
final (12 month) daily doses (% of guidelines required target dose) of the following medicaments: ACEI, ARB, beta-blocker, MRA, ARNI
Time Frame: 12 months
12 months
final (12 month) doses (mg) of the diuretics (furosemide, torasemide, hydrochlorotiazide, indapamid)
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Military Institute of Medicine, Poland

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Wroclaw Medical University
Medical University of Gdansk
4th Military Hospital
Military University of Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 5, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 17, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 26, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STRATEGMED3/305274/8/NCBR/2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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