REALIsM-HF Pilot Study

NCT03507439 | Completed Results

• 1 other identifier: 19167
• Study Type: interventional
• Target: 27
• Locations: 3 countries
• Sites: 5

Brief Summary

The study aims to explore two marketed devices providing a multimarker monitoring including physical activity under real-life conditions in patients with heart failure with preserved ejection fraction (HFpEF) and with heart failure and reduced ejection fraction (HFrEF). It aims to identify potential novel endpoints for future heart failure trials by exploring clinically relevant changes over time and correlations/associations with conventional endpoints such as the six minute walking distance (6MWD), biomarkers and clinical events. Furthermore, it aims to address the challenges and feasibility of implementing device based measurements under real-life conditions.

Conditions

Heart Failure

Keywords

Heart failure with preserved ejection fraction (HFpEF); Heart failure with reduced ejection fraction (HFrEF)

Outcome Measures

Primary Outcomes (8)

• Daily Steps Count

  Daily steps count was measured with DynaPort Move Monitor device and evaluated to reflect the amount of daily physical activity.

  At Day 9 and Day 77

• Daily Physical Activity Level

  Movement intensity of an activity, which was the average body acceleration (g) during this activity, was measured with DynaPort Move Monitor device and evaluated as daily physical activity level (PAL). Higher values indicate higher physical activity level and intensity.

  At Day 9 and Day 77

• Total Daily Energy Expenditure

  Total daily energy expenditure was measured with DynaPort Move Monitor device and evaluated to reflect the amount of daily physical activity.

  At Day 9 and Day 77

• Duration of Daily Physical Activity

  Duration of daily physical activity was measured with DynaPort Move Monitor device.

  At Day 9 and Day 77

• Time Duration Per Activity Status

  Time duration per activity status was measured with DynaPort Move Monitor device and evaluated to reflect the intensity of daily physical activity. Physical Activity intensities use absolute aerobic intensity in terms of Metabolic Equivalent of Task (MET), which is a physiological concept expressing the energy cost of a physical activity as a multiple of Basal Metabolic Rate (BMR). By convention, 1 MET is considered as the resting metabolic rate obtained during quiet sitting. According to the American College of Sports Medicine (ACSM) thresholds for adults: Light-intensity activities are defined as 1.1 MET to 2.9 METs; Moderate-intensity activities are defined as 3.0 to 5.9 METs; Vigorous-intensity activities are defined as 6.0 METs or more.

  At Day 9 and Day 77

• Amount of Daily Physical Activity Measured With VitalPatch Biosensor

  Amount of daily physical activity was collected and measured with VitalPatch biosensor.

  Up to Day 84

• Duration of Daily Physical Activity Measured With VitalPatch Biosensor

  Duration of daily physical activity was collected and measured with VitalPatch biosensor.

  Up to Day 84

• Intensity of Daily Physical Activity Measured With VitalPatch Biosensor

  Intensity of daily physical activity was collected and measured with VitalPatch biosensor.

  Up to Day 84

Secondary Outcomes (33)

• 6-minute Walking Distance (6MWD)

  At Day 84

• Sleep Movements

  Up to Day 84

• Sleep Patterns

  Up to Day 84

• Sit-to-stand Behaviour

  Up to Day 84

• Quality of Life as Measured With the Kansas City Cardiomyopathy Questionnaire Score

  At Day 9 and Day 84

Other Outcomes (1)

• Number of Participants With Adverse Events

  From signing the ICF until follow-up visit (up to 7 months)

Study Arms (2)

HFrEF

EXPERIMENTAL

Participants with established diagnosis of heart failure with reduced ejection fraction (HFrEF; EF ≤ 35%) wore the AVIVO MPM System or VitalPatch biosensor for 5 monitoring periods with patches applied on Day 0, 9, 16, 77 and 84; and the DynaPort Move Monitor belt for 2 monitoring periods with belts applied on Day 9 and Day 77.

Device: AVIVO Mobile Patient Management (MPM) System; Device: VitalPatch biosensor; Device: DynaPort Move Monitor

HFpEF

EXPERIMENTAL

Participants with established diagnosis of heart failure with preserved ejection fraction (HFpEF; EF ≥ 45%) wore the AVIVO MPM System or VitalPatch biosensor for 5 monitoring periods with patches applied on Day 0, 9, 16, 77 and 84; and the DynaPort Move Monitor belt for 2 monitoring periods with belts applied on Day 9 and Day 77.

Device: AVIVO Mobile Patient Management (MPM) System; Device: VitalPatch biosensor; Device: DynaPort Move Monitor

Interventions

AVIVO Mobile Patient Management (MPM) System DEVICE

Wearable, wireless physiological monitoring and arrhythmia detection system, used by participants for 5 monitoring periods of 5 days each in the study

HFpEF; HFrEF

VitalPatch biosensor DEVICE

Wearable, wireless physiological monitoring and arrhythmia detection system, used by participants for 5 monitoring periods of 5 days each in the study

HFpEF; HFrEF

DynaPort Move Monitor DEVICE

Wearable device for ambulatory monitoring of physical activity, used by participants for 2 monitoring periods of 7 days each in the study

HFpEF; HFrEF

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent signed before any study-specific procedure
• Men or women aged 45 years and older
• Established diagnosis of chronic heart failure NYHA class II-IV
• Worsening heart failure requiring hospitalization for the initiation of intensification of heart failure therapy with at least one of the following: a) BNP ≥ 100 pg/mL or NT-proBNP ≥ 400 pg/mL (sinus rhythm) OR BNP ≥ 300 pg/mL or NT-proBNP ≥ 1200 pg/mL (atrial fibrillation); OR b) Radiographic evidence of pulmonary congestion (interstitial edema, pulmonary venous hypertension, vascular congestion, pleural effusion); OR c) Catheterization documented elevated filling pressures at rest (left ventricular end-diastolic pressure ≥15 mmHg or pulmonary capillary wedge pressure ≥ 20 mmHg) or with exercise (pulmonary capillary wedge pressure ≥ 25 mmHg) OR Ambulatory patients with a history of heart failure on individually optimized treatment with HF medications unless contraindicated or not tolerated, for at least 12 weeks and at least one of the following: a) Hospitalization for heart failure within the past 12 months; OR b) BNP ≥ 100 pg/mL or NT-proBNP ≥ 400 pg/mL (sinus rhythm) or BNP ≥ 300 pg/mL or NT-proBNP ≥ 1200 pg/mL (atrial fibrillation)
• Willingness to wear the DynaPort Move Monitor accelerometer belt and VitalPatch Biosensor during the trial
• Body size allows wearing of the accelerometer belt as confirmed by ability to comfortably fasten the test belt provided for the screening process

You may not qualify if:

• Inability to comply with planned study procedures or to comply with study protocol requirements; this includes completing required data collection, and attending required follow up study visits
• Hemoglobin \< 8.0 g/dl
• Acute coronary syndrome or percutaneous coronary intervention within 3 months prior to informed consent
• Listing for heart transplantation and / or anticipated implantation of a ventricular assist device
• Inability to exercise: wheelchair / scooter / walker dependent; dependent on supplemental oxygen
• Known clinically significant persistent coronary ischemia (based on medical history, a preexisting or a recent clinical stress test)
• HF is not the primary factor limiting activity within the last three months as indicated by the patient affirming #1, #2 or #3 of the following questionnaire: My ability to be active is most limited by: #1 - Joint, foot, leg, hip or back pain; #2 - Unsteadiness or dizziness impairing daily mobility; #3 - Lifestyle, weather, or I just don't like to be active
• Occurrence of any of the following within 3 months prior to informed consent: Myocardial infarction, Hospitalization for unstable angina, Stroke or transient ischemic attack, Coronary artery bypass graft (CABG), Percutaneous coronary intervention (PCI), Implantation of a cardiac resynchronization therapy device (CRTD), Major surgery (that could interfere with patients' ability to exercise)
• PCI, CABG or implantation of a CRTD planned between randomization and Visit 4
• Subject who cannot tolerate placement of external patch monitor on chest in the proposed location (ECG lead II orientation)
• Subject with known allergies or hypersensitivities to adhesives or hydrogels
• Severe uncorrected valvular heart disease
• Known clinically relevant ventricular arrhythmias (sustained ventricular tachycardia, ventricular flutter or fibrillation)
• Severe pulmonary disease with any of the following: Requirement of continuous (home) oxygen or History of chronic obstructive pulmonary disease ≥ GOLD III
• Previous (within 30 days or 5 half-lives of the investigational drug, whichever is longer) or concomitant participation in another clinical study with investigational medicinal product(s) or device(s)

Sponsors & Collaborators

• Bayer: lead

Study Sites (5)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Universitätsklinikum Köln

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Heinrich-Heine-Universität Düsseldorf

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Charité - Campus Virchow-Klinikum (CVK)

Berlin, 13353, Germany

Location

ASST Spedali Civili di Brescia

Brescia, Lombardy, 25123, Italy

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Limitations and Caveats

Due to non-compatibility of systems, data could not be derived from the VitalPatch biosensor at the time of report preparation. No evaluation was possible within this report. Further, activity data of the previous AVIVO patch as well as of the VitalPatch biosensor were not found to be scientifically evaluable. Activity data therefore were decided to be evaluated based on the DynaPort output only.

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Bayer

clinical-trials-contact@bayer.com

1-888-8422937

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2018
• First Posted: April 25, 2018
• Study Start: April 6, 2018
• Primary Completion: December 30, 2020
• Study Completion: March 12, 2021
• Last Updated: July 3, 2023
• Results First Posted: July 3, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); IT (1); DE (3)