New Model of Care in Heart Failure

NCT03476590 | Completed

• 1 other identifier: STRATEGMED3/305274/8/NCBR/2017
• Study Type: interventional
• Target: 605
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

heart failure; ambulatory care; telemedicine; impedance cardiography

Outcome Measures

Primary Outcomes (1)

• cardiovascular death and/or hospitalization for worsening heart failure (HF).

  12 months

Secondary Outcomes (8)

• cardiovascular death

  12 months

• death due to worsening of HF

  12 months

• all-cause death

  12 months

• hospitalization for worsening HF

  12 months

• cardiovascular hospitalization

  12 months

Other Outcomes (11)

• time to first hospitalization for any reason

  12 months

• time to first hospitalization for any cardiovascular reason

  12 months

• time to first hospitalization due to worsening HF

  12 months

Study Arms (2)

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.

Procedure: new model of ambulatory care with use of of non-invasive vital signs assessment and telemedicine

Interventions

new model of ambulatory care with use of of non-invasive vital signs assessment and telemedicine PROCEDURE

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.

Also known as: Patient's tailored ambulatory care based on remote telemonitoring

intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Military Institute od Medicine National Research Institute: lead
• Wroclaw Medical University: collaborator
• 4th Military Clinical Hospital with Polyclinic, Poland: collaborator
• Medical University of Gdansk: collaborator
• Military University of Technology: collaborator

Study Sites (1)

Military Institute of Medicine

Warsaw, Masovian Voivodeship, 04-141, Poland

Location

Related Publications (1)

• 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.

  PMID: 33887120 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Cardiology and Internal Diseases

Model Details: prospective, randomized (1:1), open-label and controlled, parallel group study

Study Record Dates

• First Submitted: March 17, 2018
• First Posted: March 26, 2018
• Study Start: March 5, 2018
• Primary Completion: October 31, 2020
• Study Completion: March 30, 2021
• Last Updated: March 15, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)