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"Cardiomyopathy with systolic heart failure is the leading cause of death and lower LVEF is an independent predictor of mortality at younger ages in patients with DMD." (ref: https://openres.ersjournals.com/content/9/5/00176-2023)

"Duchenne muscular dystrophy is associated with progressive cardiorespiratory failure, including left ventricular dysfunction." (ref: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8941672/)

Example

The Demographics (DM) domain is used to represent information about the participants in a clinical study. Note there are 4 participants in this DM dataset; test results are shown for 1 participant.

dm.xpt

dm.xpt

RowSTUDYIDDOMAINUSUBJIDSUBJIDRFSTDTCRFENDTCRFXSTDTCRFXENDTCRFICDTCRFPENDTCDTHDTCDTHFLSITEIDBRTHDTCAGEAGEUSEXRACEARMCDARMACTARMCDACTARMARMNRSACTARMUDCOUNTRY
1DMD-EFDMDMD-EF-01-1011012022-05-16T09:00


2022-05-16


012010-02-0712YEARSMBLACK OR AFRICAN AMERICANADrug AADrug A

USA
2DMD-EFDMDMD-EF-01-1021022022-06-13T08:00


2022-06-13


012008-05-0114YEARSMASIANADrug AADrug A

MYS
3DMD-EFDMDMD-EF-01-1031032022-07-15T10:15


2022-07-15


012003-07-1019YEARSMNATIVE HAWAIIAN OR OTHER PACIFIC ISLANDERBDrug BBDrug B

BRA
4DMD-EFDMDMD-EF-01-1041042022-09-06T09:30


2022-09-06
2023-11-23Y011999-01-1523YEARSMWHITEBDrug BBDrug B

IRL
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It is important to record the height and weight for patients with DMD since cardiac index and spirometry results are affected by body surface area.[2The Vital Signs (VS) dataset contains measurements including but not limited to blood pressure, temperature, respiration, body surface area, body mass index, height, and weight. The height in the population may be estimated from the ulna length measuring between the point of the elbow and the midpoint of the prominent bone of the wrist.

vs.xpt

vs.xpt

RowSTUDYIDDOMAINUSUBJIDVSSEQVSTESTCDVSTESTVSPOSVSORRESVSORRESUVSSTRESCVSSTRESNVSSTRESUVSLOBFXLVISITNUMVISITVSDTC
1DMD-EFVSDMD-EF-01-1011HEIGHTHeightSTANDING47in119119cm
1VISIT 12022-05-16
2DMD-EFVSDMD-EF-01-1012WEIGHTWeightSTANDING20kg2020kg
1VISIT 12022-05-16
3DMD-EFVSDMD-EF-01-1013HEIGHTHeightSTANDING52in132132cm
6VISIT 62023-04-06
4DMD-EFVSDMD-EF-01-1014WEIGHTWeightSTANDING32kg3232kg
6VISIT 62023-04-06
$warningHtml

The Cardiovascular System Findings (CV) domain contains physiological and morphological findings related to the cardiovascular system.

Rows 1-8:Show the baseline CMR ejection fraction measurements for the participant at visit 1.
Rows 9-16:Show the CMR ejection fraction measurements for the participant at visit 6.

cv.xpt

cv.xpt

RowSTUDYIDDOMAINUSUBJIDCVSEQCVLNKIDCVTESTCDCVTESTCVORRESCVORRESUCVSTRESCCVSTRESNCVSTRESUCVLOCCVMETHODCVLOBXFLVISITNUMVISITCVDTCCVDY
1DMD-EFCVDMD-EF-01-1011

ESV

End Systolic Volume32mL3232mLHEART, LEFT VENTRICLEMRI
1VISIT 12022-05-161
2DMD-EFCVDMD-EF-01-1012

EDV

End Diastolic Volume95mL9595mLHEART, LEFT VENTRICLE

MRI


1VISIT 12022-05-161
3DMD-EFCVDMD-EF-01-10132-1LVEF_CLeft Ventricular Ejection Fraction, Cal70%7070%HEART, LEFT VENTRICLEMRI
1VISIT 12022-05-161
4DMD-EFCVDMD-EF-01-10142-1CARDOUTCardiac Output5.4L/min5.45.4L/minHEART, LEFT VENTRICLE

MRI


1VISIT 12022-05-161
5DMD-EFCVDMD-EF-01-1015

ESV

End Systolic Volume24mL2424mLHEART, RIGHT VENTRICLE

MRI


1VISIT 12022-05-161
6DMD-EFCVDMD-EF-01-1016

EDV

End Diastolic Volume90mL9090mLHEART, RIGHT VENTRICLEMRI
1VISIT 12022-05-161
7DMD-EFCVDMD-EF-01-10172-1RVEF_CRight Ventricular Ejection Fraction, Cal75%7575%HEART, RIGHT VENTRICLE

MRI


1VISIT 12022-05-161
8DMD-EFCVDMD-EF-01-10182-1CARDOUTCardiac Output5.6L/min5.65.6L/minHEART, RIGHT VENTRICLE

MRI


1VISIT 12022-05-161
9DMD-EFCVDMD-EF-01-1019

ESV

End Systolic Volume37mL3737mLHEART, LEFT VENTRICLEMRI
6VISIT 62023-04-06326
10DMD-EFCVDMD-EF-01-10110

EDV

End Diastolic Volume94mL9494mLHEART, LEFT VENTRICLE

MRI


6VISIT 62023-04-06326
11DMD-EFCVDMD-EF-01-101112-2LVEF_CLeft Ventricular Ejection Fraction, Cal65%6565%HEART, LEFT VENTRICLEMRI
6VISIT 62023-04-06326
12DMD-EFCVDMD-EF-01-101122-2CARDOUTCardiac Output4.0L/min4.04.0L/minHEART, LEFT VENTRICLE

MRI


6VISIT 62023-04-06326
13DMD-EFCVDMD-EF-01-10113

ESV

End Systolic Volume36mL3636mLHEART, RIGHT VENTRICLE

MRI


6VISIT 62023-04-06326
14DMD-EFCVDMD-EF-01-10114

EDV

End Diastolic Volume93mL9393mLHEART, RIGHT VENTRICLEMRI
6VISIT 62023-04-06326
15DMD-EFCVDMD-EF-01-101152-2RVEF_CRight Ventricular Ejection Fraction, Cal70%7070%HEART, RIGHT VENTRICLE

MRI


6VISIT 62023-04-06326
16DMD-EFCVDMD-EF-01-101162-2CARDOUTCardiac Output4.0L/min4.04.0L/minHEART, RIGHT VENTRICLE

MRI


6VISIT 62023-04-06326
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

The lab test, N-terminal pro-B-type natriuretic peptide (NT-proBNP), is a biomarker used in heart failure and ejection fraction for diagnosis and treatment.[3,4] These test results are represented in the Laboratory Test Results (LB) domain.

Row 1:Shows the results for the NT-proBNP test at visit 1.
Row 2:Shows the results for the NT-proBNP test at visit 6.

lb.xpt

lb.xpt

RowSTUDYIDDOMAINUSUBJIDLBSEQLBLNKIDLBTESTCDLBTESTLBCATLBORRESLBORRESULBORNRLOLBORNRHILBSTRESCLBSTRESNLBSTRESULBSTNRLOLBSTRNHILBNRINDLBLOINCLBSPECLBLOBXFLVISITNUMVISITLBDTCLBDY
1DMD-EFLBDMD-EF-01-10112-1BNPPRONTN-Terminal ProB-type Natriuretic PeptideCHEMISTRY40pg/mL01004040ng/L0100NORMAL71425-3BLOOD
1VISIT 12022-05-161
2DMD-EFLBDMD-EF-01-10122-2BNPPRONTN-Terminal ProB-type Natriuretic PeptideCHEMISTRY900pg/mL0100900900ng/L0100HIGH71425-3BLOOD
6VISIT 62023-04-06326
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

A Related Records (RELREC) dataset is used to show the relationship between the CV and LB domains. TAUGDMDCIS-18 - Getting issue details... STATUS   TAUGDMDCIS-19 - Getting issue details... STATUS

$titleHtml

relrec.xpt

Row

STUDYID

RDOMAIN

USUBJID

IDVAR

IDVARVAL

RELTYPE

RELID

1DMD-EFCV
CVLNKID
MANY2
2DMD-EFLB
LBLNKID
ONE2
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