Zhuang 2014.
Methods | Randomised placebo‐controlled trial 16 weeks duration |
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Participants | Inclusion criteria:
Exclusion criteria:
WHO FC II/III n = 124 |
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Interventions | Tadalafil (40 mg a day) (N=60) or placebo to existing therapy with oral ambrisentan (10 mg a day) (n=64) | |
Outcomes | 6MWD Improvement in WHO functional class Clinical worsening was defined as the occurrence of the following events: death, transplantation, arterial septostomy, hospitalisation due to worsening PAH, initiation of new therapy or worsening FC by week 16 Haemodynamic parameters were measured by right‐heart catheterisation |
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Notes | Funding source not stated Trial was conducted at Shanghai Tenth People’s Hospital of Tongji University, Shanghai, China, between September 2011 and March 2013 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Type of randomisation is not clear The randomisation was stratified for baseline walking distance and type of PAH (idiopathic/familial and anorexigen use vs. other types) |
Allocation concealment (selection bias) | Low risk | Placebo‐controlled |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Placebo‐controlled |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Unclear if outcome assessors were blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Withdrawals were accounted for: In the tadalafil group: 6 participants discontinued: 3 for toxicity, 1 for worsening PAH, 2 for non‐compliance In the placebo group: 5 participants discontinued: 4 for worsening PAH; 1 for irrelevant accidental death |
Selective reporting (reporting bias) | Low risk | Prespecified outcomes were reported |
Other bias | Low risk | Other risk of bias is unlikely |
6MWD: six‐minute walk distance; BNP: brain nutrietic peptide; BODE: Body mass index, airflow Obstruction, Dyspnoea and Exercise capacity; CHF: congenital heart failure; CI: cardiac index; COPD: chronic obstructive pulmonary disease; CTEPH: chronic thromboembolic pulmonary hypertension; DCMP: dilated cardiomyopathy; DLCO: diffusing capacity for carbon monoxide; EF: ejection fraction; EPBF: effective pulmonary blood flow; ERA: endothelin receptor antagonist; FEV1: forced expiratory volume in one second; HFpEF: heart failure with preserved ejection fraction; HIV: human immunodeficiency virus; IV: intravenous; LV: left ventricle; LVEF: left ventricular ejection fraction; LVSD: left ventricular systolic dysfunction; m: metres; n: number; NT‐Pro BNP: N‐terminal prohormone of brain natriuretic peptide; NYHA: New York Heart Association; PAH: pulmonary arterial hypertension; PAP: pulmonary artery pressure; PASP: pulmonary artery systolic pressure; PAWP: pulmonary artery wedge pressure; PCWP: pulmonary capillary wedge pressure; PDA: patent ductus arteriosus; PDE5: phosphodiesterase 5; PEA: pulmonary endarterectomy; PH: pulmonary hypertension; PVR: pulmonary vascular resistance; PVRI: pulmonary vascular resistance index; QOL: quality of life; RAP: right atrial pressure; RHC: right heart catheterisation; SF‐36: short form 36; SGRQ: St George's Respiratory Questionnaire; SO2: saturation of oxygen; SVR: systemic vascular resistance; TAPSE: tricuspid annular plane systolic excursion; TLC: total lung capacity; TTE: transthoracic echocardiogram; TRV: tricuspid regurgitation velocity; VO2: volume of oxygen; WHO: World Health Organization