check_circleStudy Completed
Heart failure
Bayer Identifier:
19167
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
REALIsM-HF pilot study
Trial purpose
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.
Key Participants Requirements
Sex
AllAge
45 - N/ATrial summary
Enrollment Goal
27Trial Dates
April 2018 - March 2021Phase
N/ACould I Receive a placebo
NoProducts
VitalPatchAccepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Northwestern University Feinberg School of Medicine | Chicago, 60611, United States |
Completed | ASST Spedali Civili di Brescia | Brescia, 25123, Italy |
Completed | Charité - Campus Virchow-Klinikum (CVK) | Berlin, 13353, Germany |
Completed | Heinrich-Heine-Universität Düsseldorf | Düsseldorf, 40225, Germany |
Withdrawn | ASST Papa Giovanni XXIII | Bergamo, 24127, Italy |
Completed | Universitätsklinikum Köln | Köln, 50937, Germany |
Primary Outcome
- Daily steps countDaily steps count was measured with DynaPort Move Monitor device and evaluated to reflect the amount of daily physical activity.date_rangeTime Frame:At Day 9 and Day 77
- Daily physical activity levelMovement 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.date_rangeTime Frame:At Day 9 and Day 77
- Total daily energy expenditureTotal daily energy expenditure was measured with DynaPort Move Monitor device and evaluated to reflect the amount of daily physical activity.date_rangeTime Frame:At Day 9 and Day 77
- Duration of daily physical activityDuration of daily physical activity was measured with DynaPort Move Monitor device.date_rangeTime Frame:At Day 9 and Day 77
- Time duration per activity statusTime 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.date_rangeTime Frame:At Day 9 and Day 77
- Amount of daily physical activity measured with VitalPatch biosensorAmount of daily physical activity was collected and measured with VitalPatch biosensor.date_rangeTime Frame:Up to Day 84
- Duration of daily physical activity measured with VitalPatch biosensorDuration of daily physical activity was collected and measured with VitalPatch biosensor.date_rangeTime Frame:Up to Day 84
- Intensity of daily physical activity measured with VitalPatch biosensorIntensity of daily physical activity was collected and measured with VitalPatch biosensor.date_rangeTime Frame:Up to Day 84
Secondary Outcome
- 6-minute walking distance (6MWD)6-minute walking distance (6MWD) is a exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. An increase in the distance walked indicates improvement in basic mobility.date_rangeTime Frame:At Day 84
- Sleep movementsSleep movements was measured with DynaPort Move Monitor device.date_rangeTime Frame:Up to Day 84
- Sleep patternsSleep patterns was measured with DynaPort Move Monitor device.date_rangeTime Frame:Up to Day 84
- Sit-to-stand behaviourSit-to-stand behaviour was measured with DynaPort Move Monitor device.date_rangeTime Frame:Up to Day 84
- Quality of Life as measured with the Kansas City Cardiomyopathy Questionnaire scoreThe Kansas City Cardiomyopathy Questionnaire (KCCQ) is the leading health-related quality-of-life measure for patients with heart failure (HF). It is a 23-item questionnaire that independently measures the impact of patients’ HF, or its treatment, on 7 distinct domains: symptom frequency, symptom burden, physical limitation, quality of life, social limitations, self-efficacy and symptoms stability. Physical Limitation ranges 0-100. Total Symptom Score (range 0-100) combines the Symptom Frequency and the Symptom Burden scores; Clinical Summary Score (range 0-100) combines the Total Symptom and Physical Limitation scores to replicate the NYHA classification; Overall Summary Score (range 0-100) includes the Total Symptom, Physical Limitation, Social Limitations, and Quality of Life scores. Higher scores indicate more favorable states.date_rangeTime Frame:At Day 9 and Day 84
- Quality of life as measured with the PRO - activity scoresREALIsM-HF exploratory daily questionnaire was developed to include patient-reported outcome (PRO) items that can be administered as a daily diary in the study. Overall activity score ranges from 0 to 240 and general physical activity score ranges from 0 to 4. Higher scores indicate more favorable states.date_rangeTime Frame:At Day 9 and Day 77
- Quality of life as measured with the PRO - change in activities and symptomsREALIsM-HF exploratory daily questionnaire was developed to include patient-reported outcome (PRO) items that can be administered as a daily diary in the study. Answers to question "How have your physical activities changed since you were discharged from the hospital": 1= Very much more physically active; 2= Much more physically active; 3= A little more physically active; 4= No change in physical activities; 5= A little less physically active; 6= Much less physically active; 7= Very much less physically active. Answers to questions "How has your feeling of tiredness changed since you were discharged from the hospital", "How has your shortness of breath changed since you were discharged from the hospital" and "How has your swelling in your legs, ankles, or feet changed since you were discharged from the hospital": 1= Very much improved; 2= Much improved; 3= Minimally improved; 4= No change; 5= Minimally worse; 6= Much worse; 7= Very much worse.date_rangeTime Frame:At Day 9 and Day 77
- CopeptinBlood sample for biomarkers including Copeptin were collected from participants in order to validate such biomarkers for clinical use in the context of heart failure. Biomarkers concentration was determined in plasma/serum by a central laboratory using validated assays platforms including appropriate quality controls.date_rangeTime Frame:At Day 9 and Day 84
- Galectin-3Blood sample for biomarkers including Galectin-3 were collected from participants in order to validate such biomarkers for clinical use in the context of heart failure. Biomarkers concentration was determined in plasma/serum by a central laboratory using validated assays platforms including appropriate quality controls.date_rangeTime Frame:At Day 9 and Day 84
- Growth differentiation factor 15 (GDF 15)Blood sample for biomarkers including GDF 15 were collected from participants in order to validate such biomarkers for clinical use in the context of heart failure. Biomarkers concentration was determined in plasma/serum by a central laboratory using validated assays platforms including appropriate quality controls.date_rangeTime Frame:At Day 9 and Day 84
- Human interleukin-1 Receptor 4 / ST2 (sST2)Blood sample for biomarkers including sST2 were collected from participants in order to validate such biomarkers for clinical use in the context of heart failure. Biomarkers concentration was determined in plasma/serum by a central laboratory using validated assays platforms including appropriate quality controls. Values above upper limit of quantification (ULOQ) were substituted by ULOQ for the calculation of statistics (ULOQ = 80.0)date_rangeTime Frame:At Day 9 and Day 84
- Human insulin-like growth factor binding (IGFBP7)Blood sample for biomarkers including IGFBP7 were collected from participants in order to validate such biomarkers for clinical use in the context of heart failure. Biomarkers concentration was determined in plasma/serum by a central laboratory using validated assays platforms including appropriate quality controls.date_rangeTime Frame:At Day 9 and Day 84
- N-terminal propeptide of BNP (NT-proBNP)Blood sample for biomarkers including NT-proBNP were collected from participants in order to validate such biomarkers for clinical use in the context of heart failure. Biomarkers concentration was determined in plasma/serum by a central laboratory using validated assays platforms including appropriate quality controls.date_rangeTime Frame:At Day 9 and Day 84
- High sensitive Troponin T (hsTRT)Blood sample for biomarkers including hsTRT were collected from participants in order to validate such biomarkers for clinical use in the context of heart failure. Biomarkers concentration was determined in plasma/serum by a central laboratory using validated assays platforms including appropriate quality controls. Values below lower limit of quantification (LLOQ) were substituted by 1/2 LLOQ for the calculation of statistics (LLOQ = 13.0)date_rangeTime Frame:At Day 9 and Day 84
- Blood pressureSystolic blood pressure (SBP) and diastolic blood pressure (DBP) were collected.date_rangeTime Frame:At Day 9, Day 77 and Day 84
- Heart rateHeart rate data were collected by electrocardiogram (ECG).date_rangeTime Frame:At Day 9, Day 77 and Day 84
- Interventricular septal wall thicknessInterventricular septal wall thickness was measured by echocardiography.date_rangeTime Frame:At Day 84
- Diameter of the left ventricle in diastoleDiameter of the left ventricle in diastole was measured by echocardiography.date_rangeTime Frame:At Day 84
- Diameter of the left ventricle in systoleDiameter of the left ventricle in systole was measured by echocardiography.date_rangeTime Frame:At Day 84
- Left ventricular end-diastolic volumeLeft ventricular end-diastolic volume was measured by echocardiography.date_rangeTime Frame:At Day 84
- Left ventricular end-systolic volumeLeft ventricular end-systolic volume was measured by echocardiography.date_rangeTime Frame:At Day 84
- Left ventricular ejection fractionLeft ventricular ejection fraction was measured by echocardiography.date_rangeTime Frame:At Day 84
- Left atrial end-systolic volumeLeft atrial end-systolic volume was measured by echocardiography.date_rangeTime Frame:At Day 84
- Left atrial end systolic volume indexLeft atrial end systolic volume index was measured by echocardiography.date_rangeTime Frame:At Day 84
- Mitral peak velocity of early filling (E)Mitral peak velocity of early filling (E) was measured by echocardiography.date_rangeTime Frame:At Day 84
- Mitral peak velocity of late filling (A)Mitral peak velocity of late filling (A) was measured by echocardiography.date_rangeTime Frame:At Day 84
- Mitral lateral annulus early diastolic peak velocityMitral lateral annulus early diastolic peak velocity was measured by echocardiography.date_rangeTime Frame:At Day 84
- Mitral septal annulus early diastolic peak velocityMitral septal annulus early diastolic peak velocity was measured by echocardiography.date_rangeTime Frame:At Day 84
- Tricuspid annular plane systolic excursionTricuspid annular plane systolic excursion was measured by echocardiography.date_rangeTime Frame:At Day 84
- Pressure gradient of tricuspid valvePressure gradient of tricuspid valve was measured by echocardiography.date_rangeTime Frame:At Day 84
- Right atrial mean pressureRight atrial mean pressure was measured by echocardiography.date_rangeTime Frame:At Day 84
- Heart rate variability (HRV) derived from ECGHeart rate variability (HRV) derived from ECG were measured with AVIVO MPM and VitalPatch biosensordate_rangeTime Frame:Up to Day 84
- Number of participants per NYHA classification by visitThe New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. The Stages of Heart Failure: Class I = No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc. Class II = Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III = Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20 - 100 m). Comfortable only at rest. Class IV = Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.date_rangeTime Frame:At Day 9 and Day 84
Trial design
Trial Type
InterventionalIntervention Type
DeviceTrial Purpose
DiagnosticAllocation
N/ABlinding
N/AAssignment
Single Group AssignmentTrial Arms
2