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Trial · NCT07037836

Registered outcomes18

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

ListOutcomeTime frameDescription
PrimaryVentilation Defect Percentage (VDP) on HP129XeMRIBaseline and 4 weeks post-TyvasoDefined as the region with ventilation signals \< mean - 2SD, measured by HP129XeMRI and expressed as a percentage of total lung volume.
PrimaryMembrane Defect Percentage on HP129XeMRIBaseline and 4 weeks post-TyvasoDefined as the region with membrane signals \< mean - 2SD, measured by HP129XeMRI and expressed as a percentage of total lung volume.
PrimaryLow Membrane Region Percentage on HP129XeMRIBaseline and 4 weeks post-TyvasoDefined as the region with membrane signals between 1SD and 2SD below the mean, measured by HP129XeMRI and expressed as a percentage of total lung volume.
PrimaryRBC Transfer Defect Percentage on HP129XeMRIBaseline and 4 weeks post-TyvasoDefined as the region with RBC transfer signals \< mean - 2SD, measured by HP129XeMRI and expressed as a percentage of total lung volume.
PrimaryLow RBC Transfer Region Percentage on HP129XeMRIBaseline and 4 weeks post-TyvasoDefined as the region with RBC transfer signals between 1SD and 2SD below the mean, measured by HP129XeMRI and expressed as a percentage of total lung volume.
PrimaryRBC Oscillation Amplitude Normalized for RBC Transfer DefectBaseline and 4 weeks post-TyvasoMeasured using HP129XeMRI spectroscopy as a surrogate for pulmonary vascular resistance, normalized to RBC transfer signal intensity.
PrimaryRBC Chemical Shift on HP129XeMRI SpectroscopyBaseline and 4 weeks post-TyvasoFrequency shift in RBC signal reflecting capillary blood oxygenation, measured using HP129XeMRI spectroscopy.
SecondaryNadir SpO₂ During 6MWTBaseline and 4 weeks post-Tyvaso treatment
Lowest oxygen saturation (SpO₂) recorded during the 6-minute walk test, measured by pulse oximetry. The test is performed on room air unless SpO₂ drops below 89%, at which point supplemental oxygen is administered to maintain SpO₂ ≥89%.
SecondarySupplemental Oxygen Flow During 6MWTBaseline and 4 weeks post-Tyvaso treatmentOxygen flow rate in liters per minute required to maintain SpO₂ ≥89% during the 6-minute walk test if room air is insufficient.
Secondary6-Minute Walk Distance (6MWD)Baseline and 4 weeks post-Tyvaso treatmentTotal distance walked in meters during the 6-minute walk test, following ATS guidelines.
SecondaryDyspnea Score During 6MWTBaseline and 4 weeks post-Tyvaso treatmentSubjective rating of dyspnea severity on a 1-10 scale reported by participants at the end of the 6-minute walk test.
SecondaryPeak Heart Rate (% Predicted) During 6MWTBaseline and 4 weeks post-Tyvaso treatmentHighest heart rate achieved during the 6-minute walk test, expressed as a percentage of predicted maximum heart rate.
SecondaryForced Expiratory Volume in 1 Second (FEV1) - Absolute and % PredictedBaseline and 4 weeks post-Tyvaso treatmentEV1 measured in liters and as a percentage of predicted value, assessed by spirometry.
SecondaryForced Vital Capacity (FVC) - Absolute and % PredictedBaseline and 4 weeks post-Tyvaso treatmentFVC measured in liters and as a percentage of predicted value, assessed by spirometry
SecondaryTotal Lung Capacity (TLC) - Absolute and % PredictedBaseline and 4 weeks post-Tyvaso treatmentTLC measured in liters and as a percentage of predicted value, assessed by lung volume testing.
SecondaryResidual Volume (RV) - Absolute and % PredictedBaseline and 4 weeks post-Tyvaso treatmentRV measured in liters and as a percentage of predicted value, assessed by lung volume testing.
SecondaryDiffusing Capacity for Carbon Monoxide (DLCO) - Absolute and % PredictedBaseline and 4 weeks post-Tyvaso treatmentDLCO measured in mL/min/mmHg and as a percentage of predicted value, assessed by single-breath method.
SecondaryCarbon Monoxide Transfer Coefficient (KCO) - Absolute and % PredictedBaseline and 4 weeks post-Tyvaso treatmentKCO measured in mL CO/min/mmHg/L and as a percentage of predicted value, derived from DLCO and alveolar volume.

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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