Hfcollaboratory.com



--------------------------------------------------------------------------------------------------------------------SUPPLEMENTARY MATERIALBox 1. Conceptualized Modular Case Report Form Additions and Example Data ItemsArrhythmia Details – cardiac resynchronization therapy and defibrillator device details, anti-arrhythmic agent details and dosesEchocardiogram Details – typical echocardiographic core lab assessmentsElectrocardiogram Details –PR interval, ventricular arrhythmia details, bradycardia detailsExpanded Cardiovascular Medication Details – doses of vasodilators, digoxin, ivabradineExpanded Congenital Heart Disease AssessmentExpanded Demographics – gender at enrollment, expanded racial groupsExpanded Event Classification – mortality adjudication including sudden cardiac death, hospitalization adjudication including cardiovascular hospitalization, separation of worsening heart failure equivalents including emergency room visits, observation stays, diuretic infusion clinics, and renal failure eventsExpanded Laboratory Details – extended testing including hepatic, glycemic, nutritional, lipid, and inflammatory testing, troponinsExpanded Physical Examination and Vital Signs – temperature, pulmonary examination, abdominal examinationExpanded Surgical and Procedural History Details – radiofrequency ablation, coronary artery bypass grafting, percutaneous coronary intervention, valvular repair or replacementGenomics EvaluationMagnetic Resonance Details – typical magnetic resonance imaging core lab assessmentsMechanical Circulatory Support – use of inotropes, intra-aortic balloon pump, ventricular assist devices, extracorporeal membrane oxygenationMedication Details for Thrombosis – doses of antiplatelet and anticoagulant medicationsMedication Details for Antihyperglycemia – doses of antihyperglycemic medicationsMetabolic Profiling – inclusive of waist circumference, metabolomic profiling, biomarkersObjective Functional Assessment – 6-minute walk test, cardiopulmonary exercise test, gait speed, frailty, physical performance batteryQuality of Life Subscales and Expanded Quality of Life AssessmentsExpanded Endpoint Ascertainment – mortality subsets, hospitalization subsets, heart failure hospitalization equivalents, patient reported outcome assessmentsBox 2. Included Medical History ElementsCardiovascular Medical HistoryHospitalization for HF with in the prior 12 months, or equivalent (IV diuretics)Predominant etiology of HFPrior myocardial infarctionPrior coronary revascularization (surgical or percutaneous)Presence of moderate or severe valvular regurgitation (any cardiac valve)Presence of moderate or severe valvular stenosis (any cardiac valve)Current use of another medical device (pacemaker, ICD, CRT, CPAP, phrenic nerve stimulator, oxygen therapy)Presence of hypertensionPresence of atrial Fibrillation or flutterPresence of ventricular tachycardia or fibrillationPresence of cerebrovascular disease Presence of peripheral vascular diseaseNon-Cardiovascular Medical HistoryHistory of diabetes mellitusHistory of smokingHistory of chronic obstructive pulmonary diseaseHistory of sleep apneaHistory of depressionHistory of dyslipidemiaHistory of cancer requiring chemotherapy or radiationHistory of renal dysfunction (with Chronic Kidney Disease Stage by estimated glomerular filtration rate)Appendix A. Participants in the Lean CRF Working GroupWilliam T. AbrahamOhio State UniversityAmrut AmberdekarUniversity of Colorado, DenverSeth BilazarianAbiomedMartina BrueckmannBoehringer IngelheimChris CabellArena PharmaceuticalsDaniel CanosCenters for Medicare and Medicaid ServicesPeter CarsonVeterans Affairs Medical CenterJeffrey CerkvenikMedtronicGraziella ColluAstraZenecaMimi DeSouzaBristol-Myers SquibbPete DiBattisteJanssenMona FiuzatUS FDA; Duke UniversityAl GianchettiXyloCorMatthew HillebrennerUS FDA Division of Cardiovascular and Renal ProductsNicole IbrahimUS FDA Center for Devices and Radiological HealthRichard JacobUnaffiliated (Patient)Robert KazmierskiUS FDA Center for Devices and Radiological HealthJoerg KoglinMerckMarvin KonstamTufts UniversityJohn LaschingerUS FDA Center for Devices and Radiological HealthMartin LefkowitzNovartisJoAnn LindenfeldVanderbilt UniversityDouglas MannWashington University in St LouisChristopher M. O’ConnorInova Heart and Vascular InstituteMitchell A. PsotkaInova Heart and Vascular InstituteLothar RoessigBayerJoseph RogersDuke UniversityDaniel SchaberMedtronicMeir ShinnarUS FDA Center for Devices and Radiological HealthSteve SimonsonWindtree TherapeuticsShashank SinhaInova Heart and Vascular InstituteScott D. SolomonBrigham and Women’s HospitalPatrick VertaEdwardsEmily ZeitlerDuke UniversityBram ZuckermanUS FDA Center for Devices and Radiological HealthAppendix B. Consensus Adult Case Report Form for Devices?2019 Heart Failure CollaboratoryDEMOGRAPHICSBirth Month ____ and Birth Year ____Sex at Birth:O MaleO FemaleEthnicity:О Hispanic or LatinoО Not Hispanic or Latino О Not Reported or RefusedRace as determined by patient or family (Check all that apply)O American Indian, First Nations, or AboriginalO Alaska Native O Black or African American O Asian IndianO ChineseO FilipinoO JapaneseO KoreanO VietnameseO Other AsianO Native HawaiianO Pacific Islander (Other than Native Hawaiian)O White or CaucasianO Not Reported or RefusedPHYSICAL EXAMINATIONHeight ________ О cm О inWeight ________ О kg О lbResting Heart Rate: __________ (beats/min)Resting Systolic Blood Pressure: __________ (mmHg)Resting Diastolic Blood Pressure: _________ (mmHg)Resting Respiratory Rate: _______ (respirations/min)HF Assessment: (Dichotomous yes/no)Peripheral Edema - О yes О noRales/Rhonchi - О yes О noJugular Venous Distention (JVD) - О yes О noS3 gallop - О yes О noCARDIAC ASSESSMENTLeft Ventricular Ejection Fraction Assessment: (Within ____ months)Left Ventricular Ejection Fraction: (Single number, range not allowed) _____ %Left Ventricular Ejection Fraction Modality:О EchocardiogramО Magnetic Resonance ImagingО Gated myocardial perfusion imaging; single photon emission computed tomography (SPECT) or positron emission tomography (PET)О Gated Equilibrium Radionucleotide Ventriculography (MUGA)О Left ventricular contrast ventriculography during invasive catheterizationElectrocardiogram: (Within ____ months)О Sinus rhythmО Atrial Fibrillation/Flutter О Ventricular PacedVentricular rate _____ beats/minQRS Duration _____ millisecondsО Left Bundle Branch Block presentNYHA Class at time of consentО IО IIО IIIО IVPATIENT REPORTED OUTCOMES ASSESSMENTPatient-Reported Outcome by Qualified Medical Device Development Tool at time of Enrollment:О KCCQ (Kansas City Cardiomyopathy Questionnaire) Overall Summary Score _________О MLHFQ (Minnesota Living with HF Questionnaire) Total Score _________CARDIOVASCULAR MEDICAL HISTORYHospitalization due to Heart Failure (or equivalent) within prior 12 months? О yes О noPredominant Ischemic Etiology of Heart Failure - О yes О noCoronary Artery Disease: Previous Myocardial Infarction - О yes О noPrevious Revascularization (Coronary Artery Bypass or Percutaneous Coronary Intervention) - О yes О noKnown Moderate or Severe Valvular Regurgitation (check all that apply)О AorticО MitralО TricuspidО PulmonicО NoneKnown Moderate or Severe Valvular Stenosis (check all that apply)О AorticО MitralО TricuspidО PulmonicО NoneMedical Devices (Check all that apply)О Pacemaker (non-CRT, non-ICD)О Implantable Cardioverter-Defibrillator (ICD; non-CRT)О Cardiac Resynchronization Therapy (CRT-P, non-ICD)О Cardiac Resynchronization Therapy, Implantable Cardioverter-Defibrillator (CRT-D)О Continuous Positive Airway Pressure (CPAP)О Phrenic Nerve StimulatorО Continuous Oxygen TherapyО Durable Left Ventricular Assist DeviceО OtherО NoneHistory of Hypertension - О yes О noHistory of Atrial fibrillation/flutter - О yes О noHistory of Ventricular tachycardia/fibrillation - О yes О noHistory of Cerebrovascular Disease - О yes О noHistory of Peripheral Vascular Disease - О yes О noNON-CARDIOVASCULAR MEDICAL HISTORYHistory of Diabetes Mellitus - О None О Type 1 О Type 2 О Unknown TypeSmoking Status - О Current О Former О NeverHistory of COPD - О yes О noHistory of Sleep Apnea - О yes О noHistory of Depression - О yes О noHistory of Dyslipidemia - О yes О noHistory of Cancer Requiring Chemotherapy or Radiation - О yes О noRenal Function at Enrollment by Estimated Glomerular Filtration Rate (eGFR; Chronic Kidney Disease Stage) О I (eGFR ≥90 ml/min/1.73m2)О II (eGFR 60-89 ml/min/1.73m2)О IIIa (eGFR 45-59 ml/min/1.73m2)О IIIb (eGFR 30-44 ml/min/1.73m2)О IV (eGFR 15-29 ml/min/1.73m2)О V (eGFR <15 ml/min/1.73m2)BASELINE LABORATORY VALUESSerum Hemoglobin ____ О g/dL О mmol/lSerum Sodium ____ О mEq/l О mmol/lSerum Potassium ____ О mEq/l О mmol/lBlood Urea Nitrogen ____ О mg/dL О mmol/lSerum Creatinine ____ О mg/dL О mmol/lNatriuretic Peptides ____ О BNP О NT-proBNP (pg/ml)Serum Glucose ____ О mEq/l О mmol/lBASELINE MEDICATIONS Loop Diuretics (total daily dose, select all that apply)О Furosemide ____ mgО Torsemide ____ mgО Bumetanide ____ mgО Ethacrynic Acid ____ mgО NoneThiazide Diuretics (total daily dose, select all that apply)О Hydrochlorothiazide ____ mgО Chlorthalidone ____ mgО Chlorothiazide ____ mgО Indapamide ____ mgО Metolazone ____ mgО Methyclothiazide ____ mgО NoneMineralocorticoid Receptor Antagonists (total daily dose, select all that apply)О Spironolactone ____ mgО Eplerenone ____ mgО Canrenone ____ mgО NoneRenin-Angiotensin System Inhibitors (total daily dose, select all that apply)О Benazepril ____ mgО Captopril ____ mgО Enalapril ____ mgО Fosinopril ____ mgО Lisinopril ____ mgО Moexipril ____ mgО Perindopril ____ mgО Quinapril ____ mgО Ramipril ____ mgО Trandolapril ____ mgО Azilsartan ____ mgО Candesartan ____ mgО Eprosartan ____ mgО Irbesartan ____ mgО Losartan ____ mgО Olmesartan ____ mgО Telmisartan ____ mgО Valsartan ____ mgО Sacubitril-Valsartan ____ mgО Aliskiren ____ mgО NoneBeta-Adrenergic Receptor Blockers (total daily dose, select all that apply)О Acebutolol ____ mgО Atenolol ____ mgО Betaxolol ____ mgО Bisoprolol ____ mg О Bucindolol ____ mgО Carvedilol ____ mgО Labetalol ____ mgО Metoprolol tartrate ____ mgО Metoprolol succinate ____ mgО Nadolol ____ mgО Nebivolol ____ mgО Penbutolol ____ mgО Pindolol ____ mgО Propranolol ____ mgО NoneOTHER HF MEDICATIONSDigoxin О yes О noIvabradine О yes О noTolvaptan О yes О noHydralazine О yes О noIsosorbide-Mononitrate О yes О noIsosorbide-Dinitrate О yes О noOTHER CARDIOVASCULAR MEDICATIONSAny Antiarrhythmic Medication О yes О noAny Calcium Channel Antagonist О yes О noAspirin О yes О noAny Non-Aspirin Anti-Platelet Agent О yes О noWarfarin О yes О noAny Direct Oral Anti-Coagulant О yes О noAny Statin О yes О noAny Additional Anti-Hypertensive Medication О yes О noANTI-HYPERGLYCEMIC MEDICATIONSMetformin О yes О noAny Sulfonylurea О yes О noAny Thiazolidinedione О yes О noAny Glucagon-Like Peptide-1 (GLP-1) Antagonist О yes О noAny Dipeptidyl-peptidase-4 (DPP-4) Antagonist О yes О noAny Sodium-Glucose Co-Transporter-2 (SGLT-2) Antagonist О yes О noAny Insulin О yes О noHEART FAILURE MEDICAL AND DEVICE THERAPY EXPLANATIONRenin-Angiotensin System Inhibitor at goal dose О yes О noIf Renin-Angiotensin System Inhibitor not at goal dose, this is due to (select all that apply):О HyperkalemiaО Renal DysfunctionО HypotensionО BradycardiaО Other Side Effect or IntoleranceО Physician Decision-Making other than Side Effects or IntoleranceBeta-Adrenergic Receptor Blocker at goal dose О yes О noIf Beta-Adrenergic Receptor Blocker not at goal dose, this is due to (select all that apply):О HyperkalemiaО Renal DysfunctionО HypotensionО BradycardiaО Other Side Effect or IntoleranceО Physician Decision-Making other than Side Effects or IntoleranceMineralocorticoid Receptor Antagonist at goal dose О yes О noIf Mineralocorticoid Receptor Antagonist not at goal dose, this is due to (select all that apply):О HyperkalemiaО Renal DysfunctionО HypotensionО BradycardiaО Other Side Effect or IntoleranceО Physician Decision-Making other than Side Effects or IntoleranceEVENTSAll-Cause Mortality ________ (date)Cardiovascular Mortality О yes О noLeft Ventricular Assist Device (LVAD) or Heart Transplant ________ (date)All-Cause Hospitalization ________ (date)Heart Failure Hospitalization О yes О noOther Worsening Heart Failure Event Requiring Intravenous Diuretic ________ (date)(Emergency Department, Observation Visit, Clinic Visit, or Other Intravenous Diuretic Administration)Patient-Reported Outcome by Qualified Medical Device Development Tool:О KCCQ (Kansas City Cardiomyopathy Questionnaire) Overall Summary Score _________О MLHFQ (Minnesota Living with Heart Failure Questionnaire) Total Score _________Appendix C. Consensus Adult Case Report Form for Drugs?2019 Heart Failure Collaboratory Preamble: The Consensus Adult Lean Case Report Form for Drugs is intended to apply to most standard clinical trials of new drugs for the treatment of heart failure to be used for regulatory approval. Limitation of the data items collected may be reasonable in direct consultation with the United States Food and Drug Administration. The lean case report form for drugs is distinct from the case report form for devices in the following ways: Includes: assessment of the symptoms needed for the diagnosis of heart failure and whether heart failure was previously diagnosed.Does not include: assessment of the modality used to determine left ventricular ejection fraction (LVEF) or baseline laboratory values.DEMOGRAPHICSBirth Month ____ and Birth Year ____Sex at Birth:O MaleO FemaleEthnicity:О Hispanic or LatinoО Not Hispanic or Latino О Not Reported or RefusedRace as determined by patient or family (Check all that apply)O American Indian, First Nations, or AboriginalO Alaska Native O Black or African American O Asian IndianO ChineseO FilipinoO JapaneseO KoreanO VietnameseO Other AsianO Native HawaiianO Pacific Islander (Other than Native Hawaiian)O White or CaucasianO Not Reported or RefusedPHYSICAL EXAMINATIONHeight ________ О cm О inWeight ________ О kg О lbResting Heart Rate: __________ (beats/min)Resting Systolic Blood Pressure: __________ (mmHg)Resting Diastolic Blood Pressure: _________ (mmHg)Resting Respiratory Rate: _______ (respirations/min)Symptom Report: (Patient Reported Dichotomous yes/no)Edema - О yes О noDyspnea - О yes О noOrthopnea - О yes О noFatigue - О yes О noHeart Failure Assessment: (Clinician Assessed Dichotomous yes/no)Peripheral Edema - О yes О noRales/Rhonchi - О yes О noJugular Venous Distention (JVD) - О yes О noS3 gallop - О yes О noCARDIAC ASSESSMENTLeft Ventricular Ejection Fraction Assessment: (Within ____ months)Left Ventricular Ejection Fraction: (Single number, range not allowed) _____ %Electrocardiographic Assessment proximal to EnrollmentО Sinus rhythm or О Atrial Fibrillation/Atrial Flutter or О Atrial PacedQRS Duration _____ millisecondsО Left Bundle Branch Block presentNYHA Class at time of consentО IО IIО IIIО IVCARDIOVASCULAR MEDICAL HISTORYPrior diagnosis of heart failure - О yes О noHospitalization due to heart failure (or equivalent) within the prior 12 months - О yes О noPredominant ischemic etiology of heart failure - О yes О noKnown Coronary Artery Disease - О yes О noPrevious Myocardial Infarction - О yes О noPrevious Revascularization (Coronary Artery Bypass or Percutaneous Coronary Intervention) - О yes О noKnown Moderate or Severe Valvular Regurgitation (check all that apply)О AorticО MitralО TricuspidО PulmonicО NoneKnown Moderate or Severe Valvular Stenosis (check all that apply)О AorticО MitralО TricuspidО PulmonicО NoneMedical Devices (Check all that apply)О Pacemaker (non-CRT, non-ICD)О Implantable Cardioverter-Defibrillator (ICD; non-CRT)О Cardiac Resynchronization Therapy (CRT-P, non-ICD)О Cardiac Resynchronization Therapy, Implantable Cardioverter-Defibrillator (CRT-D)О Continuous Positive Airway Pressure (CPAP)О Phrenic Nerve StimulatorО Continuous Oxygen TherapyО Durable Left Ventricular Assist DeviceО OtherО NoneHistory of Hypertension - О yes О noHistory of Atrial fibrillation/flutter - О yes О noHistory of Ventricular tachycardia/fibrillation - О yes О noHistory of Cerebrovascular Disease - О yes О noHistory of Peripheral Vascular Disease - О yes О noHistory of Congenital Heart Disease: О yes О noNON-CARDIOVASCULAR MEDICAL HISTORYHistory of Diabetes Mellitus - О None О Type 1 О Type 2 О Unknown TypeSmoking Status - О Current О Former О NeverHistory of COPD - О yes О noHistory of Sleep Apnea - О yes О noHistory of Depression - О yes О noHistory of Dyslipidemia - О yes О noHistory of Cancer Requiring Chemotherapy or Radiation - О yes О noRenal Function at Enrollment by Estimated Glomerular Filtration Rate (eGFR) and Chronic Kidney Disease StageО I (GFR ≥90 ml/min/1.73m2)О II (GFR 60-89 ml/min/1.73m2)О IIIa (GFR 45-59 ml/min/1.73m2)О IIIb (GFR 30-44 ml/min/1.73m2)О IV (GFR 15-29 ml/min/1.73m2)О V (GFR <15 ml/min/1.73m2)Current treatment with Dialysis - О yes О noBASELINE MEDICATIONS Loop Diuretics (total daily dose, select all that apply)О Furosemide ____ mgО Torsemide ____ mgО Bumetanide ____ mgО Ethacrynic Acid ____ mgО NoneThiazide Diuretic О yes О noMineralocorticoid Receptor Antagonists (total daily dose, select all that apply)О Spironolactone ____ mgО Eplerenone ____ mgО Canrenone ____ mgО NoneRenin-Angiotensin System Inhibitors (total daily dose, select all that apply)О Benazepril ____ mgО Captopril ____ mgО Enalapril ____ mgО Fosinopril ____ mgО Lisinopril ____ mgО Moexipril ____ mgО Perindopril ____ mgО Quinapril ____ mgО Ramipril ____ mgО Trandolapril ____ mgО Azilsartan ____ mgО Candesartan ____ mgО Eprosartan ____ mgО Irbesartan ____ mgО Losartan ____ mgО Olmesartan ____ mgО Telmisartan ____ mgО Valsartan ____ mgО Sacubitril-Valsartan ____ mgО Aliskiren ____ mgО NoneBeta-Adrenergic Receptor Blockers (total daily dose, select all that apply)О Acebutolol ____ mgО Atenolol ____ mgО Betaxolol ____ mgО Bisoprolol ____ mgО Bucindolol ____ mgО Carvedilol ____ mgО Labetalol ____ mgО Metoprolol tartrate ____ mgО Metoprolol succinate ____ mgО Nadolol ____ mgО Nebivolol ____ mgО Penbutolol ____ mgО Pindolol ____ mgО Propranolol ____ mgО NoneOTHER HF MEDICATIONSDigoxin О yes О noIvabradine О yes О noTolvaptan О yes О noHydralazine О yes О noIsosorbide-Mononitrate О yes О noIsosorbide-Dinitrate О yes О noOTHER CARDIOVASCULAR MEDICATIONSAny Antiarrhythmic Medication О yes О noAny Calcium Channel Antagonist О yes О noAspirin О yes О noAny Non-Aspirin Anti-Platelet Agent О yes О noWarfarin О yes О noAny Direct Oral Anti-Coagulant О yes О noAny Statin О yes О noAny Additional Anti-Hypertensive Medication О yes О noANTI-HYPERGLYCEMIC MEDICATIONSMetformin О yes О noAny Sulfonylurea О yes О noAny Thiazolidinedione О yes О noAny Glucagon-Like Peptide-1 (GLP-1) Agonist О yes О noAny Dipeptidyl-peptidase-4 (DPP-4) Antagonist О yes О noAny Sodium-Glucose Co-Transporter-2 (SGLT-2) Antagonist О yes О noAny Insulin О yes О noHF MEDICAL THERAPY EXPLANATIONIf no Renin-Angiotensin System Inhibitor, this is due to (select all that apply):О HyperkalemiaО Renal DysfunctionО HypotensionО BradycardiaО Other Side Effect or IntoleranceО Physician Decision-Making other than Side Effects or Intolerance (including lack of indication)If no Beta-Adrenergic Receptor Blocker, this is due to (select all that apply):О HyperkalemiaО Renal DysfunctionО HypotensionО BradycardiaО Other Side Effect or IntoleranceО Physician Decision-Making other than Side Effects or Intolerance (including lack of indication)If no Mineralocorticoid Receptor Antagonist, this is due to (select all that apply):О HyperkalemiaО Renal DysfunctionО HypotensionО BradycardiaО Other Side Effect or IntoleranceО Physician Decision-Making other than Side Effects or Intolerance (including lack of indication)EVENTSAll-Cause Mortality ________ (date)Cardiovascular Mortality О yes О no О unknownAll-Cause Hospitalization ________ (date)Cardiovascular Hospitalization О yes О no О unknownHeart Failure Hospitalization О yes О no О unknown ................
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