Instructions: This form is completed and entered for all participants. Database will skip over sections that do not apply.
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1 Revision of 08/30/2017 Form #102 Page 1 of 6 PVDOMICS STUDY PVD Assessment - Form #102 Instructions: This form is completed and entered for all participants. Database will skip over sections that do not apply. For Comparators and PH Groups, complete this form after the Right Heart Catheterization. Use all medical and surgical history related to pulmonary vascular disease (PVD). Information should be obtained from medical records, local physician records, and participant interview. It should include any current diagnoses and past pertinent history. Medical records might include, but are not limited to: hospital discharge summaries, consultation letters, MD progress notes, problem lists, medication records and imaging reports [i.e. x-ray, ultrasound, CT]. 1. Identification Number 2. Alphacode. 3. Date of review: mm/dd/yyyy 4. Identify PVD status of this participant... 1=Control, go to Q200. 2=Comparator, go to Q5. 3=PH, go to Q11. COMPARATORS If Q4=2-Comparator, complete the following items Q5-Q10: 5. Was this participant diagnosed with any of these WHO Group 1 comparator diagnoses?... For Q5: 0=No, skip to Q6; 1=Yes, complete Q5a-d. For Q5a-d: use 0=No, 1=Yes a. Mild PH (mpap 21 to <25)?... b. epah (exercise mpap 30, flow <10 L/min and mpap-q slope >3) (mmhg*min/l)... c. Relative of heritable pulmonary arterial hypertension (HPAH)... d. CTD with mild (mpap 21 to <25) or no PH Was this participant diagnosed with any of these WHO Group 2 comparator diagnoses?... For Q6: 0=No, skip to Q7; 1=Yes, complete Q6a-b2 For Q6a-b2: use 0=No, 1=Yes a. Mild PVD risk associated with LHD (left heart disease with mpap <25)?... b. Moderate (PVD risk associated with LHD?... b.1. Isolated post-capillary pulmonary hypertension (Ipc-PH) mpap 25, PVR <3, DPG <7 (mmhg)?... b.2. Provocable mpcw >18 or mpcw >15 with large v waves following challenge?....
2 Page 2 of 6 7. Was this participant diagnosed with any of these WHO Group 3 comparator diagnoses?... For Q7: 0=No, skip to Q8; 1=Yes, complete Q7a-g. For Q7a-g: use 0=No, 1=Yes a. Chronic Obstructive Pulmonary Disease (COPD)?... b. Idiopathic Pulmonary Fibrosis (IPF)?... c. Other Interstitial Lung Diseases (ILD) including CPFE and SSc-ILD?... d. Obstructive Sleep Apnea (OSA)?... e. Obesity Hypoventilation Syndrome (OHS)?... f. Sarcoidosis?... g. Mild to no PVD risk (mpap <21) or Moderate PVD risk (mpap 21 to <25)? Was this participant diagnosed with this WHO Group 4 comparator diagnosis?... For Q8: 0=No, skip to Q9; 1=Yes, complete Q8a. a. Chronic PE with mild to no PVD (mpap <25)? (0=No, 1=Yes) What is the Primary WHO Group Comparator classification?... 1=WHO Group 1 3=WHO Group 3 2=WHO Group 2 4=WHO Group What is the Secondary WHO Group Comparator classification?... 1=WHO Group 1 3=WHO Group 3 8=Not applicable 2=WHO Group 2 4=WHO Group 4 If Q5-10 were answered, skip to Q19 comments for Adjudication Committee PULMONARY HYPERTENSION (PH) Answer Q11-end of form. 11. a. How was participant diagnosed with pulmonary hypertension (PH) at time of enrollment (Form 100 enroll date)?... 1=Diagnosed by right heart cath (RHC) 2=Diagnosed by testing but not including RHC 3=PH suspected b. Was a WHO PH Group previously identified for this participant?... (0=No, skip to 11d, 1=Yes, complete Q11c) c. If yes, what group?... 1=WHO Group 1 5=WHO Group 5 2=WHO Group 2 6=Mixed 3=WHO Group 3 9=Unknown 4=WHO Group 4
3 Page 3 of 6 d. Date of PH diagnosis (mm/dd/yyyy)... / / If day of diagnosis is unknown, insert 15. Any of the following PH associated medical conditions: WHO Group 1 Review Pulmonary arterial hypertension (PAH) 12. Was this participant diagnosed with any of these WHO Group 1 diagnoses?... For Q12: 0=No, skip to Q13; 1=Yes, complete Q12a-j. For Q12a-j: use 0=No, 1=Yes: a. IPAH (Idiopathic pulmonary arterial hypertension)?... b. FPAH (Familial pulmonary arterial hypertension)?... b.1. Hereditary hemorrhagic telangiectasia (HHT)... c. Drug-induced pulmonary arterial hypertension?... d. Connective tissue disease (CTD)?... d.1. Systemic lupus erythematosus (Lupus) (SLE)?... d.2. Sjogrens?... d.3. Rheumatoid Arthritis (RA)?... d.4. Mixed connective tissue disease (MCTD)?... d.5. Systemic sclerosis (SSc)?... d.6. Antisynthestase syndrome... e. Human immunodeficiency virus (HIV) infection induced PH?... f. Portal hypertension... g. Congenital heart disease (CHD)... g.1 Was the shunt repaired?... h. Schistosomiasis?... i. Pulmonary-capillary hemangiomatosis (PCH)?... j. Pulmonary veno-occlusive disease (PVOD)?... WHO Group 2 Review PH due to Heart Diseases 13. Was this participant diagnosed with any of these WHO Group 2 diagnoses?... For Q13: 0=No, skip to Q14; 1=Yes, complete Q13a-d. For Q13a-d2: use 0=No, 1=Yes: a. Valvular heart disease?... a.1. Stenotic?... a.2. Regurgitant?...
4 Page 4 of 6 b. Systolic heart failure?... c. Heart failure with preserved ejection fraction?... d. Cardiomyopathy?... d.1. Hypertrophic?... d.2. Restrictive?... WHO Group 3 Review PH due to Lung Disease and/or Hypoxemia 14. Was this participant diagnosed with any of these WHO Group 3 diagnoses?... For Q14: 0=No, skip to Q15; 1=Yes, complete Q14a-i. For Q14a-i: 0=No, 1=Yes: a. Chronic obstructive pulmonary disease (COPD)?... b. Idiopathic pulmonary fibrosis (IPF)?... c. Combined pulmonary fibrosis and emphysema (CPFE)?... d. Other interstitial lung disease (ILD)?... e. Obstructive sleep apnea (OSA)?... f. Non-parenchymal restrictive lung disease (RLD)?... g. Obesity hypoventilation syndrome (OHS)?... h. Hypersensitivity pneumonitis?... i. Thoracic cage abnormality?... WHO Group 4 Review 15. Was this participant diagnosed with any of these WHO Group 4 diagnoses?... For Q15: 0=No, skip to Q16; 1=Yes, complete Q15a-c. a. Chronic thromboembolic pulmonary hypertension (CTEPH) (0=No, 1=Yes)... b. Pulmonary thromboendarterectomy (PTE) (0=No, 1=Yes)... c. Balloon pulmonary angioplasty (BPA) (0=No, 1=Yes)... WHO Group 5 Review 16. Was this participant diagnosed with any of these WHO Group 5 diagnoses?... For Q16: 0=No, skip to Q17; 1=Yes, complete Q16a-c2. For Q16a-c2: Use 0=No, 1=Yes: a. Sarcoidosis?... b. Myeloproliferative Disease?... c. Hemoglobinopathy?... c.1. Sickle Cell?... c.2. Thalassemia?...
5 Page 5 of What WHO Group does the PVDOMICS Study Team think this participant falls into now?... 1=WHO Group 1 5=WHO Group 5 2=WHO Group 2 6=Mixed (must complete Q17a-c, Q18a-e, 3=WHO Group 3 and Q19-Comments) 4=WHO Group 4 If response to Q17=6=Mixed, please identify WHO Groups using the codes below: 1=WHO Group 1 4=WHO Group 4 2=WHO Group 2 5=WHO Group 5 3=WHO Group 3 8=Not applicable a. What is the Primary WHO Group classification?... b. What is the Secondary WHO Group classification?... c. What is the Tertiary WHO Group classification?... If Q17 a and b = WHO Groups 1 and/or 2 and/or 3, complete Q18: Note: Participant can only be classified once in Q18a-e: 18. a. Is this participant s PH considered Mixed WHO Groups 2 & 3 as defined below (0=No, skip to 18c, 1=Yes)... Definition: PCW > 18, LAH, LAE, atrial fib AND COPD, IPF, SSc-ILD, OHS, OSA, non-parenchymal restrictive lung diagnosis or CPFE b. What is mixed WHO Group for 2 and 3?... 1=WHO 2, 3: acute worsening in PCW with fluid challenge, exercise, pulmonary vasodilator 2=WHO 3, 2: acute worsening of oxygenation or only mild elevation of PCW c. Is this participant s PH considered WHO 1 & 3 as described below (0=No, 1=Yes)... Features of WHO 1: i.e, autoimmune serology, positive family history AND mild (COPD, IPF, SSc-ILD, OHS, OSA, non-parenchymal restrictive lung diagnosis, CPFE); ie. evidence of progressive PH in response to activity and/or over time with stability of hypoxemia or mild parenchymal lung disease d. Is this participant s PH considered WHO 1, 2 as described below (0=No, 1=Yes)... WHO 1, 2: PAH (WHO 1, autoimmune serology) with provocation elevation in PCW e. Is this participant s mixed PH described as other? (0=No, 1=Yes)... If other, please describe and provide rationale in Comments below. 19. Comments for Adjudication Committee (enter into database). Continue on next page.
6 Page 6 of Username of physician reviewing/completing this form... (Username is the first 6 letters of physician's last name and first initial.) *This should be the center PI or other study physician trained on the PVDOMICS RHC protocol Date this form completed (mm/dd/yyyy)... / / 201. Username of person reviewing completeness of this form... Clinical Center Use Only Date form entered (mm/dd/yyyy) / / Username of person entering this form
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