Trial · NCT03655704
Apabetalone for Pulmonary Arterial Hypertension: a Pilot Study
NCT03655704, Early phase 1, Completed, Steeve Provencher
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Apabetalone for Pulmonary Arterial Hypertension: a Pilot Study. Trials, record NCT03655704. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03655704
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Apabetalone for Pulmonary Arterial Hypertension: a Pilot Study
- NCT number
- NCT03655704
- Status
- Completed
- Phases
- Early phase 1
- Enrollment
- 7 participants, actual
- Lead sponsor
- Steeve Provencher
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Apabetalone
- First posted
- 2018-08-31
- Last updated
- 2022-04-25
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Pulmonary Vascular Resistance (PVR), dyn·s·cm-5 | Baseline,and 16 weeks later | Right heart catheterization: Measuring PVR is performed in a standardized manner in catheterization laboratories of the participating centres, according to recommendations. Printed copies of waveforms will be kept for monitoring visits and documentation of the accuracy of the pressures and calculations. |
| Other | Change in mean Pulmonary Artery Pressure (mPAP), mmHg | At screening and 16 weeks later | The hemodynamic definition of pulmonary arterial hypertension (PAH) is a mean pulmonary artery pressure at rest greater than or equal to 25 mmHg in the presence of a pulmonary capillary wedge pressure less than or equal to 15 mmHg. These measurements can only be taken accurately during a right heart catheterization. |
| Other | Change in cardiac output (L/min) | At screening and 16 weeks later | Catheterization |
| Other | Change in right atrial pressure (RAP), mmHg | At screening and 16 weeks later | Catheterization |
| Other | Change in mixed venous oxygen saturation (SvO2), % | At screening and 16 weeks later | Catheterization |
| Other | Change in the 6-min walk distance (6MWD), meters | Screening, Week 0 (baseline), Week 4, Week 8 and Week 16 | The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise. |
| Other | Change in WHO functional class | Screening, Week 0 (baseline), Week 4, Week 8, Week 16 and end of study | There are four functional classes that are used to rate how ill PH patients are. Class I: No symptoms of pulmonary arterial hypertension with exercise or at rest. Class II: No symptoms at rest but uncomfortable and short of breath with normal activity such as climbing a flight of stairs, grocery shopping, or making the bed. Class III: May not have symptoms at rest but activities greatly limited by shortness of breath, fatigue, or near fainting. Class IV: Symptoms at rest and severe symptoms with any activity. |
| Other | Change in plasma N-terminal pro-brain natriuretic peptide (NT-proBNP) concentration | Week 0 (baseline), Week 8, and Week 16 | To assess changes in inflammatory/calcification mediators (mRNA \& serum proteins) of PAH patients with apabetalone treatment and demonstrate on-target beneficial effects, plasma (EDTA tubes) and whole blood (mRNA; PAXgene tubes) samples will be collected in subjects at visits 0 (baseline), 8 weeks, and 16 weeks. Blood draws at the 8 and 16 week visits should occur 4-6 hours post apabetalone dose to optimize capture of apabetalone's impact on gene expression (mRNA analysis). The plasma samples (EDTA tubes) will be processed and stored at -80°C until shipment on dry ice for future exploratory biomarker analysis relevant to lipid and inflammatory pathways. Whole blood samples (PAXgene tubes) will be stored at -20°C until shipment on dry ice to evaluate gene expression changes. |
| Other | Change in Quality of life (QoL) using Emphasis-10 questionnaire | Week 0 (baseline), and Week 16 | The Emphasis-10 questionnaire is a short questionnaire for assessing HRQoL in pulmonary arterial hypertension. It has excellent measurement properties and is sensitive to differences in relevant clinical parameters. |
| Other | Change in biomarker samples | Week 0 (baseline), Week 8, and Week 16 | circulating levels and transcription (messenger RNA) changes in whole blood of vascular calcification markers (alkaline phosphatase, osteoprotegerin), inflammation (C-reactive protein, fibrinogen, and inflammatory cytokines), complement, acute phase response, fibrogenesis and metabolism (adiponectin, ApoA-I, LDL-C and HDL-C) |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers81
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03655704
GET https://conductscience.org/api/trials/v1/NCT03655704/papers?page=2