Heart Failure Medical History aCRF

Illustrates Domains

MH
RS
CM
CV
HO

Illustrates Variables

MHEVDTYP
MHPRC
MHETOLGY
MHEVLINT
MHCRNORD
RSORRES
CMOCCUR
HOOCCUR
CVMETHOD

Content

This example CRF collects information on the subject's heart failure. Any general medical history, including comorbidities, would be collected on the general medical history CRF and information on hospitalizations would be reported on the healthcare utilization CRF. These are not shown here; however, examples can be found in the CDASHIG (https://www.cdisc.org/standards/foundational/cdash).

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	Medical History Category MHCAT Hidden/pre-populated	Heart Failure History
Record the type of heart failure.	What type of heart failure does the subject have? HF_MHTERM MHTERM	Heart failure with preserved ejection fraction (HFpEF) Heart failure with midrange ejection fraction (HFmrEF) Heart failure with reduced ejection fraction (HFrEF)
	HF_MHPRESP MHPRESP where MHTERM=HF_MHTERM Hidden/pre-populated	Y <From NY codelist>
Record the diagnosis date of the heart failure using this format (DD-MON-YYYY).	What was the date of diagnosis of heart failure? HF_MHSTDAT MHSTDTC where MHTERM=HF_MHTERM	_________________
	Medical History Event Date Type HF_MHEVDTYP MHEVDTYP Hidden/pre-populated	DIAGNOSIS
Record the primary cause of heart failure. Ensure that this event is recorded on the general medical history CRF.	What was the primary cause of heart failure? MHPRC NSMH.MHPRC where MHTERM=HF_MHTERM	High blood pressure Coronary artery disease Faulty heart valves Cardiomyopathy Abnormal heart rhythms Other, specify
Record the primary cause if "Other, specify" was checked.	Specify Other MHPRCOTH NSMH.MHPRCOTH	_________________
Record the etiology.	What is the etiology of the heart failure? MHETOLGY NSMH.MHETOLGY where MHTERM=HF_MHTERM	Ischemic Non-ischemic
Record the subject's NYHA classification at entry into the study.	What was the NYHA functional classification at entry into the study? NYHACLS_RSORRES RSORRES where RSTESTCD=*to be determined and RSDTC=VISDAT	I II III IV
Record whether the subject ever received IV diuretics for heart failure. If Yes, record the IV diuretics used on the Concomitant Medication CRF.	Was the subject ever administered IV diuretics for heart failure? IVD_CMOCCUR CMOCCUR where CMTRT ="DIURETIC" and CMROUTE="INTRAVENOUS" and CMCAT="PRIOR HEART FAILURE MEDICATION"	Yes No <From NY codelist>
Record whether the subject had any episodes of worsening heart failure in the last 6 months	Did the subject have any episodes of worsening heart failure in the last 6 months? HFWOR _MHOCCUR MHOCCUR where MHTERM="WORSENING HEART FAILURE"	Yes No <From NY codelist>
	Medical History Evaluation Interval HFWOR_MHEVLINT MHEVLINT where MHTERM="WORSENING HEART FAILURE" Hidden/pre-populated	-P6M
	Chronological Order HFWOR_MHCRNORD NSMH.MHCRNORD where MHTERM="WORSENING HEART FAILURE" Hidden/pre-populated	MOST RECENT
	Medical History Event Date Type HFWOR_MHEVDTYP MHEVDTYP where MHTERM="WORSENING HEART FAILURE" Hidden/pre-populated	EPISODE
Record the start date of the most recent episode of worsening heart failure (as defined in the protocol) in the last 6 months using this format (DD-MON-YYYY).	What was the start date of the most recent episode of worsening heart failure in the last 6 months? HFWOR_MHSTDAT MHSTDTC where MHTERM="WORSENING HEART FAILURE"	_________________
If Yes, record the hospitalization on the healthcare utilization CRF.	Did this event require hospitalization? HOOCCUR HOOCCUR where HOTERM="HOSPITAL" and NSHO.HOINDC="WORSENING HEART FAILURE" and HOEVLINT="-P6M" and HOPRESP="Y"	Yes No <From NY codelist>
Record date of the estimated LVEF measurements using this format (DD-MON-YYYY).	What was the date of the test to determine estimated LVEF? CVDAT CVDTC where CVTESTCD="LVEF_E"	_________________
	Unit LVEF_E_CVORRESU CVORRESU where CVTESTCD="LVEF_E" Hidden/pre-populated	% <From UNIT codelist>
Record the method.	What was the method used to determine the estimated LVEF? LVEF_E_CVMETHOD CVMETHOD where CVTESTCD="LVEF_E"	MUGA Echocardiography Cardiac catheterization Cardiac CT scan Cardiac MRI <From METHOD codelist>

View CRF Metadata

Order	CDASH Variable	Question Text	Prompt	CRF Completion Instructions	Type	SDTMIG Target	SDTM Variable Mapping	Controlled Terminology Code List Name	CRF Implementation notes	Permissible Values	Pre-specified Value	List Style	Hidden
1	MHCAT	What was the category of the medical history?	Medical History Category	If collected on the CRF, the sponsor provides instructions to ensure the data is entered as intended.	text	MHCAT	MHCAT				Heart Failure History		Y
2	HF_MHTERM	What type of heart failure does the subject have?	Medical History Term	Record the type of heart failure.	text	MHTERM	MHTERM			Heart failure with preserved ejection fraction (HFpEF); Heart failure with midrange ejection fraction (HFmrEF); Heart failure with reduced ejection fraction (HFrEF)
3	HF_MHPRESP	N/A	N/A	N/A	text	MHPRESP	MHPRESP where MHTERM=HF_MHTERM	(NY)			Y	Radio	Y
4	HF_MHSTDAT	What was the date of diagnosis of heart failure?	Chronic Heart Failure Diagnosis Date	Record the diagnosis date of the heart failure using this format (DD-MON-YYYY).	text	MHSTDTC	MHSTDTC where MHTERM=HF_MHTERM
5	HF_MHEVDTYP	What was the medical history event date type?	Medical History Event Date Type	N/A	text	MHEVDTYP			The instructions depend upon the format of the CRF. Sponsors may pre-print these values on the CRF or use them as defaulted or hidden text.		DIAGNOSIS		Y
6	MHPRC	What was the primary cause of heart failure?	Primary cause	Record the primary cause of heart failure. Ensure that this event is recorded on the general medical history CRF.	text	NSMH.MHPRC	NSMH.MHPRC where MHTERM=HF_MHTERM			High blood pressure; Coronary artery disease; Faulty heart valves; Cardiomyopathy; Abnormal heart rhythms; Other, specify		Radio
7	MHPRCOTH	Specify Other	Primary cause, other	Record the primary cause if "Other, specify" was checked.	text	NSMH.MHPRCOTH
8	MHETOLGY	What is the etiology of the heart failure?	Etiology	Record the etiology.	text	MHORRES	NSMH.MHETOLGY where MHTERM=HF_MHTERM			Ischemic; Non-ischemic		Radio
9	NYHACLS_RSORRES	What was the NYHA functional classification at entry into the study?	NYHA Classification Result	Record the subject's NYHA classification at entry into the study.	text	RSORRES	RSORRES where RSTESTCD=*to be determined and RSDTC=VISDAT		This will be represented in the RS domain. A QRS supplement will be published with the appropriate terminology.	I; II; III; IV		Radio
10	IVD_CMOCCUR	Was the subject ever administered IV diuretics for heart failure?	IV Diuretics Medications	Record whether the subject ever received IV diuretics for heart failure. If Yes, record the IV diuretics used on the Concomitant Medication CRF.	text	CMOCCUR	CMOCCUR where CMTRT ="DIURETIC" and CMROUTE="INTRAVENOUS" and CMCAT="PRIOR HEART FAILURE MEDICATION"	(NY)		Yes;No		Radio
11	HFWOR _MHOCCUR	Did the subject have any episodes of worsening heart failure in the last 6 months?	Worsening Heart Failure Episodes	Record whether the subject had any episodes of worsening heart failure in the last 6 months		MHOCCUR	MHOCCUR where MHTERM="WORSENING HEART FAILURE"	(NY)	The definition of this term would be described in the protocol.	Yes;No
12	HFWOR_MHEVLINT	N/A	Medical History Evaluation Interval	N/A	text	MHEVLINT	MHEVLINT where MHTERM="WORSENING HEART FAILURE"				-P6M		Y
13	HFWOR_MHCRNORD	N/A	Chronological Order	N/A	text	NSMH.MHCRNORD	NSMH.MHCRNORD where MHTERM="WORSENING HEART FAILURE"				MOST RECENT		Y
14	HFWOR_MHEVDTYP	What was the medical history event date type?	Medical History Event Date Type	The instructions depend upon the format of the CRF. Sponsors may print these values on the CRF or use them as defaulted or hidden text.	text	MHEVDTYP	MHEVDTYP where MHTERM="WORSENING HEART FAILURE"				EPISODE		Y
15	HFWOR_MHSTDAT	What was the start date of the most recent episode of worsening heart failure in the last 6 months?	Worsening Heart Failure Start Date	Record the start date of the most recent episode of worsening heart failure (as defined in the protocol) in the last 6 months using this format (DD-MON-YYYY).	text	MHSTDTC	MHSTDTC where MHTERM="WORSENING HEART FAILURE"
16	HOOCCUR	Did this event require hospitalization?	Hospitalization	If Yes, record the hospitalization on the healthcare utilization CRF.	text	HOOCCUR	HOOCCUR where HOTERM=”HOSPITAL” and NSHO.HOINDC=”WORSENING HEART FAILURE” and HOEVLINT=”-P6M” and HOPRESP=”Y”	(NY)		Yes;No		Radio
17	CVDAT	What was the date of the test to determine estimated LVEF?	LVEF Date	Record date of the estimated LVEF measurements using this format (DD-MON-YYYY).	text	CVDTC	CVDTC where CVTESTCD="LVEF_E"
18	LVEF_E_CVORRES	What was the estimated LVEF at entry into the study?	LVEF	Record the subject's estimated LVEF at entry into the study.	text	CVORRES	CVORRES where CVTESTCD="LVEF_E"
19	LVEF_E_CVORRESU	Unit	Unit	Record the unit.	text	CVORRESU	CVORRESU where CVTESTCD="LVEF_E"	(UNIT)			%		Y
20	LVEF_E_CVMETHOD	What was the method used to determine the estimated LVEF?	Method	Record the method.	text	CVMETHOD	CVMETHOD where CVTESTCD="LVEF_E"	(METHOD)		MUGA; Echocardiography; Cardiac catheterization; Cardiac CT scan; Cardiac MRI		Radio

*The controlled terminology for NYHA functional classification was not available when this CRF was developed.