Trial · NCT02651272
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events | 20 weeks | The occurrence of treatment emergent AEs includes having any of the following: vaso-occlusive crises requiring hospitalization; acute congestive heart failure; hypotension (defined as a mean arterial pressure less than 60mmHg); decrease in hemoglobin concentration by greater than 1 g/dL. |
| Secondary | Change in Right Arterial Pressure (RAP) | Baseline, 16 weeks | RAP will be assessed by right heart catheterization. Normal range is 2-6 mmHg. |
| Secondary | Change in Systolic Right Ventricular Pressure (RVSP) | Baseline, 16 weeks | RVSP will be assessed by right heart catheterization. Normal range is 15-25 mmHg. |
| Secondary | Change in Diastolic Pulmonary Artery Pressure (PADP) | Baseline, 16 weeks | PADP will be assessed by right heart catheterization. Normal range is 8-15 mmHg. |
| Secondary | Change in Systolic Pulmonary Artery Pressure (SPAP) | Baseline, 16 weeks | SPAP will be assessed by right heart catheterization. Normal range is 15-25 mm Hg. |
| Secondary | Change in Systemic Vascular Resistance Index (SVR) | Baseline, Week 16 | Systemic vascular resistance (SVR) will be assessed with this formula Systemic Vascular Resistance (SVR) = 80x(Mean Arterial Pressure - Mean Venous Pressure or CVP) / Cardiac Output. Normal range is 800 - 1200 dynes-sec/cm-5. |
| Secondary | Change in Cardiac Index (CI) | Baseline to Week 16 | Cardiac index (CI) will be measured in L/min/m\^2. The normal range for CI is 2.5 to 4 L/min/m\^2. |
| Secondary | Change in 6 Minute Walk Distance (6MWD) | Baseline, 16 weeks | The 6 minute walk test (6MWT) assesses distance walked over 6 minutes (6MWD) as a sub-maximal test of aerobic capacity/endurance. Participants will walk at their normal pace for 6 minutes. |
| Secondary | Assess Change of Borg Dyspnea Index | Baseline, 16 weeks | The Borg Dyspnea Index (BDI) is a 0 to 10 rated self reported numerical score used to measure dyspnea during submaximal exercise and will be administered immediately following the 6MWT. The higher the score, the more dyspnea. |
| Secondary | World Health Organization (WHO) Functional Classification | 16 weeks | The WHO functional classification will be assessed and documented with the WHO Class. Class I Patients with pulmonary hypertension (PH) but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain or near syncope. Class II Patients with PH resulting in a slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity causes undue dyspnea or fatigue, chest pain or near syncope. Class III Patients with PH resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes undue dyspnea or fatigue, chest pain or near syncope. Class IV Patients with PH with inability to carry out any physical activity without symptoms. These patients manifest signs of right heart failure. Dyspnea and/or fatigue may even be present at rest. Discomfort is increased by any physical activity. The Class is inversely related to function. |
| Secondary | Change in NT-proB-type Natriuretic Peptide (NT-pro-BNP) | Baseline, 16 weeks | The normal range for NT-pro-BNP is less than 300 picograms of BNP per milliliter (pg/ml) of blood; higher levels are less favorable. |
| Secondary | Change in Cardiac Output (CO) | Baseline, Week 16 | Cardiac output (CO) will be measured in L/min/m\^2. The normal range for CO is 4 to 8 L/min/m\^2. |
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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