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Trial · NCT01447628

Registered outcomes32

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange in Exercise Capacity - Endurance12 Weeks post study treatment
Time measured in seconds from start to end of the endurance bicycle cardiopulmonary exercise testing at 80% of the peak work rate. Peak work rate is determined by that achieved at the baseline incremental cardiopulmonary exercise test (CPET). Note that this was the primary end-point of the European study. Endurance CPET was not done in China.
PrimaryChange in Resting Pulmonary Vascular Resistance (PVR)12 weeks post study treatmentTo be measured by cardiac catheterisation in wood units.
SecondaryOxygen Consumption (VO2) Level at Peak 12 Weeks After Study Treatment12 weeks post study treatmentLevel of VO2 at peak measured during incremental cardio-pulmonary exercise testing
SecondaryOxygen Consumption (VO2) at Metabolic Threshold12 weeks post study treatmentLevel of VO2 at metabolic threshold measured during incremental cardio-pulmonary exercise test
SecondaryVentilation / Volume of Exhaled Carbon Dioxide (VE/VCO2 Slope)12 weeks post study treatmentVE/VCO2 slope measured during incremental cardio-pulmonary exercise testing
SecondaryOxygen Consumption (VO2) / Work Rate (WR) Slope12 weeks post study treatmentLevel of VO2 / WR Slope measured during incremental cardio-pulmonary exercise testing
SecondaryPeak Oxygen (O2) Pulse Rate12 weeks post study treatmentO2 pulse rate (amount of oxygen consumed per heart beat) at peak measured during incremental cardio-pulmonary exercise test
SecondaryOxygen Consumption (VO2) at the End of Endurance Cardio-pulmonary Exercise Test (CPET)12 weeks post study treatmentLevel of VO2 measured at end of endurance cardio-pulmonary exercise test. Note that endurance CPET was not done in China, so this is reported only for the European dataset.
SecondaryOxygen Consumption (VO2) at 3 Minutes12 weeks post study treatmentLevel of VO2 measured at 3 minutes into endurance cardio-pulmonary exercise test (CPET) Note that endurance CPET was not done in China, hence results are presented only for the European dataset.
SecondaryIron Indices: Serum Iron12 weeks post study treatmentMeasurement of serum iron
SecondaryIron Indices: Transferrin Saturations12 weeks post study treatmentMeasurement of serum transferrin saturations. The saturation measures the iron concentration as a proportion of the iron binding capacity of transferrin.
SecondaryIron Indices: Ferritin12 weeks post study treatmentMeasured level of serum ferritin
SecondaryIron Indices: Soluble Transferrin Receptors (sTfR)12 weeks post study treatmentMeasure of serum sTfR level. Note that this was not measured in China, hence is reported only for the European dataset.
Secondary6 Minute Walk Test: Distance Walked12 weeks post study treatmentDistance in metres walked during standardised and validated 6 minute walk test
Secondary6 Minute Walk Test: Borg Dyspnoea Score After Test12 weeks post study treatmentParticipant reported score on the modified Borg Dyspnoea scale (0-10) following 6 minute walk test. Higher scores indicate worsened dyspnoea.
SecondaryIron Indices: N-terminal Pro B-type Natriuretic Peptide (NT-pro-BNP)12 weeks post study treatmentMeasured level of NT-pro-BNP in blood sample. Note that this was not measured in China, hence is presented only for the European dataset.
SecondaryCambridge Pulmonary Hypertension Outcome Review (CAMPHOR Questionnaire): Symptom Score12 weeks post study treatment
Participant self reported symptom score using the CAMPHOR questionnaire (0-25). Scores for symptoms range from 0-25, with higher scores indicating worse symptoms. Note that this was not measured in China, hence is presented only for the European dataset.
SecondaryCambridge Pulmonary Hypertension Outcome Review (CAMPHOR Questionnaire): Activity Score12 weeks post study treatment
Participants' self reported score of their own level of activity based on the CAMPHOR questionnaire. Activity scores range from 0-30, with higher scores indicating more physical limitations Note that this was not measured in China, hence is presented only for the European dataset.
SecondaryCambridge Pulmonary Hypertension Outcome Review (CAMPHOR Questionnaire): QoL Score12 weeks post study treatment
Quality of Life score based on the Cambridge Pulmonary Hypertension Outcomes Review (CAMPHOR) questionnaire (0-25). Scores for QoL range from 0-25, with higher scores indicating worse quality of life Note that this was not measured in China, hence is presented only for the European dataset.
SecondaryMean Right Atrial Pressure (Cardiac Catheter)12 weeks post study treatmentMean right atrial pressure at rest measured by cardiac catheter

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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