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Type 1 Interferon Induced Changes to Exercise Adaptations in Systemic Lupus Erythematosus Patients (LUPEX)

Primary Purpose

Systemic Lupus Erythematosus, Interferon Deficiency

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
High Intensity Interval Training
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Systemic Lupus Erythematosus focused on measuring Cardiac adaptations, Metabolic adaptations, High intensity interval training, Interleukin-6 signature, Tumor necrosis factor signature, Interferon signature

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years by inclusion.
  • Able to provide informed consent.
  • Diagnosed SLE and fulfilling the classification criteria for SLE based on the American College of Rheumatology/EULAR criteria (SLICC)

Exclusion Criteria:

  • Health conditions that prevent participating in the exercise intervention determined by the Research Coordinator these include but are not limited to

    • Major bone fracture at inclusion
    • Significant myalgias exacerbated by physical exercise
    • Active infectious disease such as Covid-19
    • Severe symptomatic pleuritis or pericarditis
  • Corticosteroid use > 10mg/day at baseline
  • Diagnosed with diabetes mellitus by physician
  • Pregnancy
  • SLEDAI-2k (with the SELENA modifications to Proteinuria changes so as to not exclude patients with chronic proteinuria) > 10

  • Contraindications to 82Rb-PET with adenosine stress (according to local guidelines at the Dept. of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet, which are in accordance with the recommendations of the European Association of Nuclear Medicine)

    • Fever, myocarditis or endocarditis
    • Previous heart transplantation
    • Dysregulated atrial or ventricular tachyarrhythmias
    • Severe chronic obstructive pulmonary disease with a FEV1 of less than 50% of predicted
    • Second or third degree sinoatrial or atrioventricular block
    • Active bronchospasm at the time of the scan
    • Systolic blood pressure <90 or >200 mmHg at the time of the scan
    • Treatment with theophyllin within 7 days of the scan

Sites / Locations

  • Center for Physical Activity ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise

Non-Exercise

Arm Description

The patients will be randomized to 12-week supervised exercise training intervention or no exercise training. The exercise training program includes three supervised sessions per week over a 12-week period. The program consists of high intensity endurance training on ergometer bicycles. The intensity will progress throughout the 12 weeks of training. The training consists of 10 minutes of warm up at 40-60% maximum heart rate (HRmax), followed by 25 minutes of high intensity interval training (4 bouts of 4 min at >85% HRmax interspaced by 3 minutes of low intensity training at 40-60% Hrmax) and finally a 3-10 min cool-down of 50% Hrmax

Control group, therefore no supervised exercise regime. Subjects are asked to not increase habitual exercise routines.

Outcomes

Primary Outcome Measures

Changes in maximal aerobic capacity (VO2max)
Measured by VO2max test
Patient reported Fatigue
measured by Fatigue Severity Scale Questionnaire (FSS)

Secondary Outcome Measures

Y2K updated SLE disease activity (SLEDAI-2K) with the SELENA modifications
Physician evaluated changes in measures of SLE on a scale of 0-105 encompassing symptoms from 9 organs, higher scores indicate increased disease activity.
Short Form (SF)-36 Health Survey (0-100)
Patient reported outcome measures (PROMs), Possible scores range from 0 to 100, with higher scores representing better health status
Change in Epigenetic Expression related to IFN alpha
Measured by mRNA analysis

Full Information

First Posted
July 21, 2022
Last Updated
October 12, 2023
Sponsor
Rigshospitalet, Denmark
Collaborators
Copenhagen Lupus and Vasculitis Clinic, Center for Rheumatology and Spine Diseases, Rigshospitalet
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1. Study Identification

Unique Protocol Identification Number
NCT05478018
Brief Title
Type 1 Interferon Induced Changes to Exercise Adaptations in Systemic Lupus Erythematosus Patients
Acronym
LUPEX
Official Title
Type 1 Interferon Induced Changes to Exercise Adaptations in Systemic Lupus
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
Copenhagen Lupus and Vasculitis Clinic, Center for Rheumatology and Spine Diseases, Rigshospitalet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Investigating the physiological effects of the interferons type 1 and 2 (IFNs), and the cytokines Interleukin 6 (IL-6) and tumor necrosis factor (TNF) on the adaptive changes to exercise in patients with systemic lupus erythematosus (SLE). The investigators hypothesize that the pathogenic blockage of IL-6 signalling that occurs in SLE, will decrease the cardiac and metabolic adaptations to aerobic exercise, and this decrease can be related to the IFN signature. 60 patients will be included in a 12-week investigator blinded 1:1 randomised high intensity aerobic exercise intervention study.
Detailed Description
60 patients with SLE, will be included and randomized in a 1:1 fashion to a 12 week high intensity interval training (HIIT) course or standard care. Randomization will be stratified by sex. All patients will undergo baseline and followup testing including: VO2Max, Pulmonary Function, Capillaroscopy, OGTT, Blood Tests, Epigenetic Markers of IFN, TNF and IL-6 signalling, Echocardiography,DXA, Medical Examination, Acute Exercise Bout with blood tests during and after an exercise bout similar to the intervention. A subgroup of patients will be offered a 82-Rb Pet CT of the heart as opt-in. The exercise programme consists of 12 weeks of tri-weekly exercise bouts of 38-45 minutes, following warm-up subjects will undergo 4 sets of 4 minute high intensity exercise, measured as the pulse being above 85% of HRmax for more than half the time; and 3 minute low to medium intensity exercise between the high intensity sets, measured as the pulse being between 40 to 60% of HRmax.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus, Interferon Deficiency
Keywords
Cardiac adaptations, Metabolic adaptations, High intensity interval training, Interleukin-6 signature, Tumor necrosis factor signature, Interferon signature

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Description
The patients will be randomized to 12-week supervised exercise training intervention or no exercise training. The exercise training program includes three supervised sessions per week over a 12-week period. The program consists of high intensity endurance training on ergometer bicycles. The intensity will progress throughout the 12 weeks of training. The training consists of 10 minutes of warm up at 40-60% maximum heart rate (HRmax), followed by 25 minutes of high intensity interval training (4 bouts of 4 min at >85% HRmax interspaced by 3 minutes of low intensity training at 40-60% Hrmax) and finally a 3-10 min cool-down of 50% Hrmax
Arm Title
Non-Exercise
Arm Type
No Intervention
Arm Description
Control group, therefore no supervised exercise regime. Subjects are asked to not increase habitual exercise routines.
Intervention Type
Behavioral
Intervention Name(s)
High Intensity Interval Training
Other Intervention Name(s)
Aerobic Exercise
Intervention Description
Supervised high-intensity interval training for 12 weeks three times per week
Primary Outcome Measure Information:
Title
Changes in maximal aerobic capacity (VO2max)
Description
Measured by VO2max test
Time Frame
12 weeks
Title
Patient reported Fatigue
Description
measured by Fatigue Severity Scale Questionnaire (FSS)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Y2K updated SLE disease activity (SLEDAI-2K) with the SELENA modifications
Description
Physician evaluated changes in measures of SLE on a scale of 0-105 encompassing symptoms from 9 organs, higher scores indicate increased disease activity.
Time Frame
12 weeks
Title
Short Form (SF)-36 Health Survey (0-100)
Description
Patient reported outcome measures (PROMs), Possible scores range from 0 to 100, with higher scores representing better health status
Time Frame
12 weeks
Title
Change in Epigenetic Expression related to IFN alpha
Description
Measured by mRNA analysis
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Systemic Lupus Erythematosus Disease Activity Index 2000 Responder Index-50 (SRI-50)
Description
Itemized Physician evaluated changes in measures of SLEDAI-2K on a scale from 0-22 that account for partial improvements in condition, higher scores indicate increased disease activity.
Time Frame
12 weeks
Title
Visual Analog Scale (VAS) of global disease by Physician (0-100%)
Description
Physician evaluated changes in measures of SLE (0-100% of line segment), higher scores equal higher disease activity (worse)
Time Frame
12 weeks
Title
Visual Analog Scale (VAS) fatigue (0-100)
Description
Patient reported outcome measures (PROMs) , higher scores equal higher fatigue (worse)
Time Frame
12 weeks
Title
Visual Analog Scale (VAS) pain (0-100)
Description
Patient reported outcome measures (PROMs), higher scores equal more pain (worse)
Time Frame
12 weeks
Title
SLAQ - (range 0 -33)
Description
Patient reported outcome measures (PROMs), Possible scores range from 0 to 33, with higher scores representing more active SLE (worse)
Time Frame
12 weeks
Title
SLE activity Visual Analog Scale - (1-10)
Description
Patient reported outcome measures (PROMs), Possible scores range from 1 to 10, with higher scores representing more active SLE
Time Frame
12 weeks
Title
Proteinuria
Description
Measured by Dipstick in a semiquantitive manner with the following categories indicating increased concentration, negative, +/-, 1+, 2+, 3+, 4+.
Time Frame
12 weeks
Title
Body composition - Total adipose tissue - Weight
Description
Measured by DXA Scan - fat(g)
Time Frame
12 weeks
Title
Body composition - Total adipose tissue - Percentage
Description
Measured by DXA Scan - fat(%)
Time Frame
12 weeks
Title
Body composition - Android adipose tissue - Weight
Description
Measured by DXA Scan - android fat(g)
Time Frame
12 weeks
Title
Body composition - Android adipose tissue - Percentage
Description
Measured by DXA Scan - android fat(%)
Time Frame
12 weeks
Title
Body composition - Gyneoid adipose tissue - Weight
Description
Measured by DXA Scan - Gyneoid fat(g)
Time Frame
12 weeks
Title
Body composition - Gyneoid adipose tissue - Percentage
Description
Measured by DXA Scan - Gyneoid fat(%)
Time Frame
12 weeks
Title
Body composition - Total Lean Mass - Weight
Description
Measured by DXA Scan - Muscle Mass(g)
Time Frame
12 weeks
Title
Body composition - Bone Mass Density - Weight/square-centimeter
Description
Measured by DXA Scan - BMD(g/cm^2)
Time Frame
12 weeks
Title
Waist-To-Height Ratio
Description
measured with tape measure
Time Frame
12 weeks
Title
Dynamic Spirometry - Forced Expiratory Volume at 1 second (FEV1) volume
Description
Pulmonary function testing, FEV1 volume
Time Frame
12 weeks
Title
Dynamic Spirometry - Forced Expiratory Volume at 1 second (FEV1) Percent of expected
Description
Pulmonary function testing, FEV1%
Time Frame
12 weeks
Title
Dynamic Spirometry - Forced Vital Capacity Volume
Description
Pulmonary function testing, FVC Volume
Time Frame
12 weeks
Title
Dynamic Spirometry - Forced Vital Capacity - Percent of Expected
Description
Pulmonary function testing FVC%
Time Frame
12 weeks
Title
Dynamic Spirometry Forced Expiratory Volume at 1 second (FEV1) by Forced Vital Capacity - Ratio
Description
Pulmonary function testing, FEV1/FVC ratio
Time Frame
12 weeks
Title
Dynamic Spirometry Forced Expiratory Volume at 1 second (FEV1) by Forced Vital Capacity - Ratio - Percentage of expected
Description
Pulmonary function testing, FEV1/FVC ratio %
Time Frame
12 weeks
Title
Dynamic Spirometry - Total Lung Capacity - Volume
Description
Pulmonary function testing, TLC Volume
Time Frame
12 weeks
Title
Dynamic Spirometry - Total Lung Capacity - Percentage of expected
Description
Pulmonary function testing, TLC%
Time Frame
12 weeks
Title
Dynamic Spirometry - Residual Volume - Volume
Description
Pulmonary function testing, RV-Volume
Time Frame
12 weeks
Title
Dynamic Spirometry - Residual Volume - Percentage of Expected
Description
Pulmonary function testing, RV%
Time Frame
12 weeks
Title
Dynamic Spirometry - Alveolar Volume - Volume
Description
Pulmonary function testing, AV-Volume
Time Frame
12 weeks
Title
Dynamic Spirometry - Alveolar Volume - Percentage of expected
Description
Pulmonary function testing, AV-%
Time Frame
12 weeks
Title
Dynamic Spirometry - Diffusing capacity for Carbon Monoxide - Volume
Description
Pulmonary function testing, DLCOc-Volume
Time Frame
12 weeks
Title
Dynamic Spirometry - Diffusing capacity for Carbon Monoxide - Percentage
Description
Pulmonary function testing, DLCOc-%
Time Frame
12 weeks
Title
Dynamic Spirometry - Carbon monoxide transfer coefficient - diffusing capacity per liter of lung volume
Description
Pulmonary function testing, KCO-Volume
Time Frame
12 weeks
Title
Dynamic Spirometry - Carbon monoxide transfer coefficient - diffusing capacity per liter of lung volume - percentage of expected
Description
Pulmonary function testing, KCO-%
Time Frame
12 weeks
Title
Oral glucose tolerance test
Description
75g of glucose taken while fasting
Time Frame
12 weeks
Title
Peripheral Capillary Changes - Capillary Density
Description
Measured by Nailfold Capillaroscopy by trained physician (score of 1-4, higher scores equal fewer capillaries)
Time Frame
12 weeks
Title
Peripheral Capillary Changes - Average Capillary Width (micrometers)
Description
Measured by Nailfold Capillaroscopy by trained physician - Width Measured in µm
Time Frame
12 weeks
Title
Peripheral Capillary Changes - Average Capillary Length(micrometers)
Description
Measured by Nailfold Capillaroscopy by trained physician - Length Measured in µm
Time Frame
12 weeks
Title
Peripheral Capillary Changes - Count of avascular areas
Description
Measured by Nailfold Capillaroscopy by trained physician - Avascular Areas (1-4 higher scores indicate more avascular areas)
Time Frame
12 weeks
Title
Peripheral Capillary Changes - Capillary Disorganization
Description
Measured by Nailfold Capillaroscopy by trained physician - Capillary Disorganization (1-4 higher scores indicate more avascular areas)
Time Frame
12 weeks
Title
Peripheral Capillary Changes - Microhemorrhages (average per finger)
Description
Measured by Nailfold Capillaroscopy by trained physician - Microhemorrhages (avg per finger)
Time Frame
12 weeks
Title
Peripheral Capillary Changes - Bushy Capillaries (average per millimeter)
Description
Measured by Nailfold Capillaroscopy by trained physician - Bushy Capillaries (average per millimeter)
Time Frame
12 weeks
Title
Peripheral Capillary Changes - Megacapillaries (average per millimeter)
Description
Measured by Nailfold Capillaroscopy by trained physician - Megacapillaries (average per millimeter)
Time Frame
12 weeks
Title
Peripheral Capillary Changes - Meandering capillaries (average per millimeter)
Description
Measured by Nailfold Capillaroscopy by trained physician - Meandering capillaries (average per millimeter)
Time Frame
12 weeks
Title
Peripheral Capillary Changes - Tortous capillaries (average per millimeter)
Description
Measured by Nailfold Capillaroscopy by trained physician - Tortous capillaries (average per millimeter)
Time Frame
12 weeks
Title
Peripheral Capillary Changes - Other Findings
Description
Measured by Nailfold Capillaroscopy by trained physician - Physicians comment
Time Frame
12 weeks
Title
Change in fasting total cholesterol, low-density lipoprotein (LDL)-cholesterol and high-density lipoprotein (HDL)-cholesterol (mmol/L). Following an overnight fast (10 hours)
Description
blood samples are collected and processed by a trained laboratory technician and analysed according to standard procedures.monitors (AX3; Axivity, Newcastle upon Tyne, UK) for a 3 to 5 day period
Time Frame
12 weeks
Title
Change in triglycerides (mmol/L). Following an overnight fast (10 hours)
Description
blood samples are collected and processed by a trained laboratory technician and analysed according to standard procedures.monitors (AX3; Axivity, Newcastle upon Tyne, UK) for a 3 to 5 day period
Time Frame
12 weeks
Title
left ventricular and atrial end-diastolic volume
Description
measured by echocardiography
Time Frame
12 weeks
Title
global longitudinal strain
Description
measured by echocardiography
Time Frame
12 weeks
Title
stroke volume
Description
measured by echocardiography
Time Frame
12 weeks
Title
left ventricular ejection fraction
Description
measured by echocardiography
Time Frame
12 weeks
Title
Left ventricular mass
Description
measured by echocardiography
Time Frame
12 weeks
Title
coronary perfusion reserve
Description
measured by echocardiography (& 82Rb-PET-CT)
Time Frame
12 weeks
Title
Myocardial blood flow
Description
Measured by 82Rb-Pet-CT, on a subset of 40 participants
Time Frame
12 weeks
Title
Axial accelerometer-based physical activity monitors
Description
Free-living physical activity is measured using axial accelerometer-based physical activity monitors (AX3; Axivity, Newcastle upon Tyne, UK) for a 3 to 5 day period
Time Frame
12 weeks
Title
Change in peripheral blood Adaptation to Acute Exercise Bout - Analyzed for High Sensitvity C-Reactive Protein
Description
Analyzed for HS-CRP
Time Frame
12 weeks
Title
Change in peripheral blood Adaptation to Acute Exercise Bout - Analyzed for Il-6
Description
Analyzed for Il-6
Time Frame
12 weeks
Title
Change in peripheral blood Adaptation to Acute Exercise Bout - Analyzed for sIL-6r
Description
Analyzed for soluble Il-6-receptor
Time Frame
12 weeks
Title
Change in peripheral blood Adaptation to Acute Exercise Bout - Analyzed for Il-1
Description
Analyzed for Il-1
Time Frame
12 weeks
Title
Change in peripheral blood Adaptation to Acute Exercise Bout - Analyzed for Il-10
Description
Analyzed for Il-10
Time Frame
12 weeks
Title
Change in peripheral blood Adaptation to Acute Exercise Bout - Analyzed for IFNα
Description
Analyzed for IFNα
Time Frame
12 weeks
Title
Change in peripheral blood Adaptation to Acute Exercise Bout - Analyzed for IFNγ
Description
Analyzed for IFNγ
Time Frame
12 weeks
Title
Change in peripheral blood Adaptation to Acute Exercise Bout - Analyzed for hgb
Description
Analyzed for hemoglobin
Time Frame
12 weeks
Title
Change in peripheral blood Adaptation to Acute Exercise Bout - Analyzed for plates
Description
Analyzed for thrombocytes
Time Frame
12 weeks
Title
Change in peripheral blood Adaptation to Acute Exercise Bout - Analyzed for Na
Description
Analyzed for sodium
Time Frame
12 weeks
Title
Change in peripheral blood Adaptation to Acute Exercise Bout - Analyzed for K
Description
Analyzed for potassium
Time Frame
12 weeks
Title
Change in peripheral blood Adaptation to Acute Exercise Bout - Analyzed for Cl
Description
Analyzed for chloride
Time Frame
12 weeks
Title
Change in peripheral blood Adaptation to Acute Exercise Bout - Analyzed for hct
Description
Analyzed for hematocrit.
Time Frame
12 weeks
Title
Change in peripheral blood Adaptation to Acute Exercise Bout - Analyzed for Ferritin
Description
Analyzed for ferritin
Time Frame
12 weeks
Title
Change in peripheral blood Adaptation to Acute Exercise Bout - Analyzed for leucocyte differential
Description
Analyzed for Leukocyte Differential
Time Frame
12 weeks
Title
Change in Epigenetic Expression related to IFN Beta
Description
Measured by mRNA analysis on PBMCs
Time Frame
12 weeks
Title
Change in Epigenetic Expression related to IFN Gamma
Description
Measured by mRNA analysis
Time Frame
12 weeks
Title
Change in Epigenetic Expression related to TNF
Description
Measured by mRNA analysis
Time Frame
12 weeks
Title
Change in Epigenetic Expression related to IL-6
Description
Measured by mRNA analysis on PBMCs
Time Frame
12 weeks
Title
Dietary Changes - Energy intake (kJ/day)
Description
Patient Reported by dietary diary
Time Frame
12 weeks
Title
Dietary Changes - carbohydrate intake (g/day)
Description
Patient Reported by dietary diary
Time Frame
12 weeks
Title
Dietary Changes - lipid intake (g/day)
Description
Patient Reported by dietary diary
Time Frame
12 weeks
Title
Dietary Changes - Protein intake (g/day)
Description
Patient Reported by dietary diary
Time Frame
12 weeks
Title
Dietary Changes - Other intake (categorical)
Description
Patient Reported by dietary diary
Time Frame
12 weeks
Title
Muscle Biopsy for epigenetic markers of inflammation and myokine signalling
Description
Optional for Participants: mRNA expression of genes related to TNF, IL-6, IFN alpha, beta and Gamma signalling
Time Frame
12 weeks
Title
Muscle Biopsy for epigenetic markers of physical activity
Description
Optional for Participants: NF-κB p65 DNA binding activity (ELISA), phosphorylated and total JNK, phosphorylated AMPK (p-AMPK) total AMPK (Western blotting).
Time Frame
12 weeks
Title
Muscle Biopsy for epigenetic markers of physical activity - NF-κB p65 DNA binding activity (ELISA)
Description
Optional for Participants: NF-κB p65 DNA binding activity (ELISA) & NF-κB binding activity (Western blotting).
Time Frame
12 weeks
Title
Muscle Biopsy for epigenetic markers of physical activity - c-Jun N-terminal kinase
Description
Optional for Participants: phosphorylated and total JNK,
Time Frame
12 weeks
Title
Muscle Biopsy for epigenetic markers of physical activity - AMP-activated protein kinase
Description
Optional for Participants: phosphorylated AMPK (p-AMPK) total AMPK (Western blotting).
Time Frame
12 weeks
Title
Autonomic Nerve Function Test - Resting HR by Vagus(tm)
Description
Resting heart rate measured by R-R intervals on 1-lead ECG
Time Frame
12 weeks
Title
Autonomic Nerve Function Test - Rise from supine ratio of RR by Vagus(tm)
Description
Rise from supine ratio of R-R intervals on 1-lead ECG
Time Frame
12 weeks
Title
Autonomic Nerve Function Test - Expiration Inspiration ratio of RR by Vagus(tm)
Description
Expiration/Inspiration ratio of R-R intervals on 1-lead ECG
Time Frame
12 weeks
Title
Autonomic Nerve Function Test - Valsalva Maneuver ratio of RR by Vagus(tm)
Description
Valsalva Maneuver ratio of R-R intervals on 1-lead ECG
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years by inclusion. Able to provide informed consent. Diagnosed SLE and fulfilling the classification criteria for SLE based on the American College of Rheumatology/EULAR criteria (SLICC) Exclusion Criteria: Health conditions that prevent participating in the exercise intervention determined by the Research Coordinator these include but are not limited to Major bone fracture at inclusion Significant myalgias exacerbated by physical exercise Active infectious disease such as Covid-19 Severe symptomatic pleuritis or pericarditis Corticosteroid use > 10mg/day at baseline Diagnosed with diabetes mellitus by physician Pregnancy SLEDAI-2k (with the SELENA modifications to Proteinuria changes so as to not exclude patients with chronic proteinuria) > 10 Contraindications to 82Rb-PET with adenosine stress (according to local guidelines at the Dept. of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet, which are in accordance with the recommendations of the European Association of Nuclear Medicine) Fever, myocarditis or endocarditis Previous heart transplantation Dysregulated atrial or ventricular tachyarrhythmias Severe chronic obstructive pulmonary disease with a FEV1 of less than 50% of predicted Second or third degree sinoatrial or atrioventricular block Active bronchospasm at the time of the scan Systolic blood pressure <90 or >200 mmHg at the time of the scan Treatment with theophyllin within 7 days of the scan
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Malte L Adamsen, MD
Phone
23271805
Ext
0045
Email
malte.lund.adamsen.02@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Regitse H Christensen, MD, PhD
Phone
23714598
Ext
0045
Email
Regitse.Hoejgaard.Christensen@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronan Martin G Berg, MD, DMSc
Organizational Affiliation
Center for Physical Activity Research
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Iben E Rasmussen, MSc
Organizational Affiliation
Center for Physical Activity Research
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Simon Jønck, MD
Organizational Affiliation
Center for Physical Activity Research
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Malte L Adamsen, MD
Organizational Affiliation
Center for Physical Activity Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Physical Activity Research
City
Copenhagen
ZIP/Postal Code
2200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regitse H Christensen, PhD, MD
Phone
+453545 7544
Email
regitse.hoejgaard.christensen@regionh.dk
First Name & Middle Initial & Last Name & Degree
Malte L Adamsen, MD
Phone
+4523271805
Email
malte.lund.adamsen.02@regionh.dk
First Name & Middle Initial & Last Name & Degree
Malte L Adamsen, MD
First Name & Middle Initial & Last Name & Degree
Regitse H Christensen, MD, PhD
First Name & Middle Initial & Last Name & Degree
Simon Jønck, MD
First Name & Middle Initial & Last Name & Degree
Ronan Martin G Berg, MD, DMSc
First Name & Middle Initial & Last Name & Degree
Iben E Rasmussen, MSc

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data obtained through this study may be provided to qualified researchers with academic interest in Systemic Lupus Erythematosus. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
IPD Sharing Time Frame
Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis
IPD Sharing Access Criteria
Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact Malte.Lund.Adamsen.02@regionh.dk, Soeren.Jacobsen.01@regionh.dk or Regitse.hoejgaard.Christensen@regionh.dk

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Type 1 Interferon Induced Changes to Exercise Adaptations in Systemic Lupus Erythematosus Patients

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