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. 2008 Jul 15;5(5):623–630. doi: 10.1513/pats.200802-020SK

TABLE 3.

RANDOMIZED CLINICAL TRIALS IN PAH WITH HRQoL AS SECONDARY OUTCOME

Year Reference Intervention N Design Etiology of PAH NYHA Class Follow-up Interval 6MWD Change Instrument(s) Used HRQoL Findings
1996 (37) Epoprostenol 81 Randomized, open-label, controlled IPAH III, IV 12 wk 113m NHP, CHQ Significant improvement in all 4 domains of CHQ, 2 of 6 domains of NHP
2002 (38) Iloprost 203 Randomized, placebo-controlled IPAH, CTD, AA, CTEPH III, IV 12 wk 36m EQ-5D utility index and VAS, SF-12 Significant improvement in EQ-5D VAS. Nonsignificant trend in EQ-5D utility index. No change in SF-12.
2002 (39) Treprostinil 470 Randomized, double-blind, placebo-controlled IPAH, CTD, CHD II, III, IV 12 wk 16m MLHFQ Significant improvement in physical dimension score of MHLFQ. Nonsignificant trend in total MHLFQ score.
2003 (40) Beraprost 116 Randomized, double-blind, placebo-controlled IPAH, CTD, CHD II, III 3, 6 mo 22-31m MLHFQ No significant improvement in total MLHFQ or subscores.
2004 (41) Sildenafil 22 Randomized, double-blind, crossover IPAH II, III 6 wk 44%↑ exercise time CHQ Significant improvement in dyspnea and fatigue domains of CHQ. Nonsignificant trend in emotional domain.
2004 (42) Sitaxsentan 178 Randomized, double-blind, placebo-controlled IPAH, CTD, CHD II, III, IV 12 wk 33-35m SF-36 No significant differences in SF-36.
2004 (43) Treprostinil 90 Post hoc analysis of RCT CTD II, III, IV 12 wk 21m MLHFQ Nonsignificant trend toward improvement in physical dimension score of MLHFQ.
2005 (44) Ambrisentan 64 Randomized, double-blind, dose-ranging IPAH, CTD, HIV, AA II, III 12 wk 36m VAS Significant improvement in VAS compared to baseline.
2005 (45) Sildenafil v. Bosentan 26 Randomized, double-blind IPAH, CTD III 16 wk 55m KCCQ No significant difference in HRQoL scores between treatments by intent-to-treat. Significant difference between treatments by per-protocol analysis.
2006 (46) Exercise training 30 Randomized, controlled PAH, CTEPH II, III, IV 15 wk 111m SF-36 Significant improvement in SF-36 PCS, MCS, as well as physical functioning, role-physical, social functioning, mental health, and vitality domains.
2007 (47) Sitaxsentan 42 Post hoc analysis of RCT CTD II, III 12 wk 58m SF-36 Significant improvement in physical functioning and role-physical domains.

Definition of abbreviations: 6MWD = six-minute walk distance; AA = anorexigen-associated pulmonary arterial hypertension; CHD = pulmonary arterial hypertension associated with congenital heart disease; CHQ = Chronic Heart Failure Questionnaire; CTD = pulmonary arterial hypertension associated with connective disuse disease; CTEPH = chronic thromboembolic pulmonary hypertension; EQ-5D = EuroQol; HIV = pulmonary arterial hypertension associated with human immunodeficiency virus; IPAH = idiopathic pulmonary arterial hypertension; KCCQ = Kansas City Cardiomyopathy Questionnaire; MLHFQ = Minnesota Living with Heart Failure Questionnaire; NHP = Nottingham Health Profile; NYHA = New York Heart Association; PAH = Pulmonary arterial hypertension; PCS = Physical Component Summary; RCT = randomized controlled trial; SF-36 = Medical Outcome Study 36-item Short Form Health Survey; VAS = visual analog score.