Basic Systolic Function

Cardiorespiratory failure is a common cause of death for patients with Duchenne muscular dystrophy. Current therapies may delay the progression of heart failure for this population. Measuring left ventricular ejection fraction (LVEF) regularly can show the rate of decline in left ventricle function for a patient.[1] (ref: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8941672/)

This section illustrates how the results of several systolic function tests, and accompanying data, are represented using the Study Data Tabulation Model (SDTM).

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

Row	STUDYID	DOMAIN	USUBJID	SUBJID	RFSTDTC	RFICDTC	DTHDTC	DTHFL	SITEID	BRTHDTC	AGE	AGEU	SEX	RACE	ARMCD	ARM	ACTARMCD	ACTARM	COUNTRY
1	DMD-EF	DM	DMD-EF-01-101	101	2022-05-16T09:00	2022-05-16			01	2010-02-07	12	YEARS	M	BLACK OR AFRICAN AMERICAN	A	Drug A	A	Drug A	USA
2	DMD-EF	DM	DMD-EF-01-102	102	2022-06-13T08:00	2022-06-13			01	2008-05-01	14	YEARS	M	ASIAN	A	Drug A	A	Drug A	MYS
3	DMD-EF	DM	DMD-EF-01-103	103	2022-07-15T10:15	2022-07-15			01	2003-07-10	19	YEARS	M	NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER	B	Drug B	B	Drug B	BRA
4	DMD-EF	DM	DMD-EF-01-104	104	2022-09-06T09:30	2022-09-06	2023-11-23	Y	01	1999-01-15	23	YEARS	M	WHITE	B	Drug B	B	Drug B	IRL

$warningHtml

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.[2] The 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

Row	STUDYID	DOMAIN	USUBJID	VSSEQ	VSTESTCD	VSTEST	VSPOS	VSORRES	VSORRESU	VSSTRESC	VSSTRESN	VSSTRESU	VISITNUM	VISIT	VSDTC
1	DMD-EF	VS	DMD-EF-01-101	1	HEIGHT	Height	STANDING	47	in	119	119	cm	1	VISIT 1	2022-05-16
2	DMD-EF	VS	DMD-EF-01-101	2	WEIGHT	Weight	STANDING	20	kg	20	20	kg	1	VISIT 1	2022-05-16
3	DMD-EF	VS	DMD-EF-01-101	3	HEIGHT	Height	STANDING	52	in	132	132	cm	6	VISIT 6	2023-04-06
4	DMD-EF	VS	DMD-EF-01-101	4	WEIGHT	Weight	STANDING	32	kg	32	32	kg	6	VISIT 6	2023-04-06

$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

Row	STUDYID	DOMAIN	USUBJID	CVSEQ	CVLNKID	CVTESTCD	CVTEST	CVORRES	CVORRESU	CVSTRESC	CVSTRESN	CVSTRESU	CVLOC	CVMETHOD	VISITNUM	VISIT	CVDTC	CVDY
1	DMD-EF	CV	DMD-EF-01-101	1		ESV	End Systolic Volume	32	mL	32	32	mL	HEART, LEFT VENTRICLE	MRI	1	VISIT 1	2022-05-16	1
2	DMD-EF	CV	DMD-EF-01-101	2		EDV	End Diastolic Volume	95	mL	95	95	mL	HEART, LEFT VENTRICLE	MRI	1	VISIT 1	2022-05-16	1
3	DMD-EF	CV	DMD-EF-01-101	3	2-1	LVEF_C	Left Ventricular Ejection Fraction, Cal	70	%	70	70	%	HEART, LEFT VENTRICLE	MRI	1	VISIT 1	2022-05-16	1
4	DMD-EF	CV	DMD-EF-01-101	4	2-1	CARDOUT	Cardiac Output	5.4	L/min	5.4	5.4	L/min	HEART, LEFT VENTRICLE	MRI	1	VISIT 1	2022-05-16	1
5	DMD-EF	CV	DMD-EF-01-101	5		ESV	End Systolic Volume	24	mL	24	24	mL	HEART, RIGHT VENTRICLE	MRI	1	VISIT 1	2022-05-16	1
6	DMD-EF	CV	DMD-EF-01-101	6		EDV	End Diastolic Volume	90	mL	90	90	mL	HEART, RIGHT VENTRICLE	MRI	1	VISIT 1	2022-05-16	1
7	DMD-EF	CV	DMD-EF-01-101	7	2-1	RVEF_C	Right Ventricular Ejection Fraction, Cal	75	%	75	75	%	HEART, RIGHT VENTRICLE	MRI	1	VISIT 1	2022-05-16	1
8	DMD-EF	CV	DMD-EF-01-101	8	2-1	CARDOUT	Cardiac Output	5.6	L/min	5.6	5.6	L/min	HEART, RIGHT VENTRICLE	MRI	1	VISIT 1	2022-05-16	1
9	DMD-EF	CV	DMD-EF-01-101	9		ESV	End Systolic Volume	37	mL	37	37	mL	HEART, LEFT VENTRICLE	MRI	6	VISIT 6	2023-04-06	326
10	DMD-EF	CV	DMD-EF-01-101	10		EDV	End Diastolic Volume	94	mL	94	94	mL	HEART, LEFT VENTRICLE	MRI	6	VISIT 6	2023-04-06	326
11	DMD-EF	CV	DMD-EF-01-101	11	2-2	LVEF_C	Left Ventricular Ejection Fraction, Cal	65	%	65	65	%	HEART, LEFT VENTRICLE	MRI	6	VISIT 6	2023-04-06	326
12	DMD-EF	CV	DMD-EF-01-101	12	2-2	CARDOUT	Cardiac Output	4.0	L/min	4.0	4.0	L/min	HEART, LEFT VENTRICLE	MRI	6	VISIT 6	2023-04-06	326
13	DMD-EF	CV	DMD-EF-01-101	13		ESV	End Systolic Volume	36	mL	36	36	mL	HEART, RIGHT VENTRICLE	MRI	6	VISIT 6	2023-04-06	326
14	DMD-EF	CV	DMD-EF-01-101	14		EDV	End Diastolic Volume	93	mL	93	93	mL	HEART, RIGHT VENTRICLE	MRI	6	VISIT 6	2023-04-06	326
15	DMD-EF	CV	DMD-EF-01-101	15	2-2	RVEF_C	Right Ventricular Ejection Fraction, Cal	70	%	70	70	%	HEART, RIGHT VENTRICLE	MRI	6	VISIT 6	2023-04-06	326
16	DMD-EF	CV	DMD-EF-01-101	16	2-2	CARDOUT	Cardiac Output	4.0	L/min	4.0	4.0	L/min	HEART, RIGHT VENTRICLE	MRI	6	VISIT 6	2023-04-06	326

$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

Row	STUDYID	DOMAIN	USUBJID	LBSEQ	LBLNKID	LBTESTCD	LBTEST	LBCAT	LBORRES	LBORRESU	LBORNRLO	LBORNRHI	LBSTRESC	LBSTRESN	LBSTRESU	LBSTNRLO	LBSTRNHI	LBNRIND	LBLOINC	LBSPEC	LBLOBXFL	VISITNUM	VISIT	LBDTC	LBDY
1	DMD-EF	LB	DMD-EF-01-101	1	2-1	BNPPRONT	N-Terminal ProB-type Natriuretic Peptide	CHEMISTRY	40	pg/mL	0	100	40	40	ng/L	0	100	NORMAL	71425-3	BLOOD		1	VISIT 1	2022-05-16	1
2	DMD-EF	LB	DMD-EF-01-101	2	2-2	BNPPRONT	N-Terminal ProB-type Natriuretic Peptide	CHEMISTRY	900	pg/mL	0	100	900	900	ng/L	0	100	HIGH	71425-3	BLOOD		6	VISIT 6	2023-04-06	326

$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
1	DMD-EF	CV		CVLNKID		MANY	2
2	DMD-EF	LB		LBLNKID		ONE	2

$warningHtml

For more information on the domains used in this section see:

Demographics (DM) - SDTMIG v3.4, Section 5.2
Vital Signs (VS) - SDTMIG v3.4, Section 6.3.13
Cardiovascular System Findings (CV) - SDTMIG v3.4, Section 6.3.7.2
Laboratory Test Results (LB) - SDTMIG v3.4, Section 6.3.5.6
Related Records (RELREC) - SDTMIG v3.4, Section 8.2.1

Space shortcuts

Page tree