Trial · NCT05339087
Efficacy and Safety of Riociguat in Incipient Pulmonary Vascular Disease as an Indicator for Early PAH
NCT05339087, Phase 2, Terminated, Heidelberg University; results first posted 2026-01-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Riociguat in Incipient Pulmonary Vascular Disease as an Indicator for Early PAH. Trials, record NCT05339087. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05339087
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Riociguat in Incipient Pulmonary Vascular Disease as an Indicator for Early PAH
- NCT number
- NCT05339087
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 35 participants, actual
- Lead sponsor
- Heidelberg University
- Conditions
- Pulmonary Vascular Disorder, Primary Pulmonary Hypertension, Systemic Sclerosis, Other Systemic Involvement of Connective Tissue
- Interventions
- Riociguat Oral Tablet, Placebo
- First posted
- 2022-04-21
- Last updated
- 2026-01-21
- Results first posted
- 2026-01-21
- Limitations and caveats
Sample size reduction to 50% limits statistical power in this two-armed study design. 24-week treatment may have been too short to assess long-term outcomes, especially with reduced exposure due to early end of study (not safety-related). Drug effects may appear less distinct (verum), clinical worsening less pronounced (control), reducing effect size. Baseline imbalances and placebo effects affected interpretation of subjective endpoints. No advanced imaging/biomarker endpoints were included.
Source ClinicalTrials.gov
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change of Pulmonary Vascular Resistance (PVR) | baseline, 24 weeks | Change in pulmonary hemodynamics assessed by right heart catheterization |
| Secondary | Change of Cardiac Index (CI) at Rest From Baseline at 24 Weeks | baseline, 24 weeks | Change in pulmonary hemodynamics assessed by right heart catheterization |
| Secondary | Change of Total Pulmonary Resistance (TPR) From Baseline at 24 Weeks | baseline, 24 weeks | Change in Pulmonary hemodynamics assessed by right heart catheterization Hierarchical testing of secondary endpoints stopped after first step. |
| Secondary | Change of Diffusion Capacity of the Lung (DLCO) From Baseline at 24 Weeks | baseline, 24 weeks | Change assessed by lung function tests. Hierarchical testing of secondary endpoints stopped after first step. |
| Secondary | Change in 6-minute Walking Distance (6MWD) | baseline, 24 weeks | Change in exercise capacity assessed by 6-minute walking distance test Hierarchical testing of secondary endpoints stopped after first step. |
| Secondary | Change of World Health Organization- Functional Class (WHO-FC) From Baseline at 24 Weeks | baseline, 24 weeks | Change of WHO functional class, change score The World Health Organization (WHO) functional class (FC) describes the severity of pulmonary hypertension (PH) symptoms. FC I is considered the mildest and FC IV the most severe form of PH. |
| Other | Change of World Health Organization- Functional Class (WHO-FC) From Baseline at 12 Weeks | baseline, 12 weeks | Change of WHO functional class, change score The World Health Organization (WHO) functional class (FC) describes the severity of pulmonary hypertension (PH) symptoms. FC I is considered the mildest and FC IV the most severe form of PH. |
| Other | Change in Quality of Life (QoL) From Baseline at 24 Weeks | baseline, 24 weeks | Quality of Life (QoL) was assessed using the Short Form (SF) 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated |
| Other | Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline at 24 Weeks | baseline, 24 weeks | Lung function and lung diffusing capacity |
| Other | Change in Total Lung Capacity (TLC) From Baseline at 24 Weeks | baseline, 24 weeks | Lung function and lung diffusing capacity |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 registered outcomesOutcomes31
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change of Pulmonary Vascular Resistance (PVR) | baseline, 24 weeks | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed paticipants may vary due to missing data for specific outcome measures. The per-protocol set is identical to the intention-to-treat set, as no major protocol deviations occurred and all participants met the predefined eligibility criteria. | WU | MEAN |
| SECONDARY | Change of Cardiac Index (CI) at Rest From Baseline at 24 Weeks | baseline, 24 weeks | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed paticipants may vary due to missing data for specific outcome measures. The per-protocol set is identical to the intention-to-treat set, as no major protocol deviations occurred and all participants met the predefined eligibility criteria. | l/min/m2 | MEAN |
| SECONDARY | Change of Total Pulmonary Resistance (TPR) From Baseline at 24 Weeks | baseline, 24 weeks | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed paticipants may vary due to missing data for specific outcome measures. The per-protocol set is identical to the intention-to-treat set, as no major protocol deviations occurred and all participants met the predefined eligibility criteria. | mmHg·min/L | MEAN |
| SECONDARY | Change of Diffusion Capacity of the Lung (DLCO) From Baseline at 24 Weeks | baseline, 24 weeks | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed paticipants may vary due to missing data for specific outcome measures. The per-protocol set is identical to the intention-to-treat set, as no major protocol deviations occurred and all participants met the predefined eligibility criteria. | percent predicted | MEAN |
| SECONDARY | Change in 6-minute Walking Distance (6MWD) | baseline, 24 weeks | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed paticipants may vary due to missing data for specific outcome measures. The per-protocol set is identical to the intention-to-treat set, as no major protocol deviations occurred and all participants met the predefined eligibility criteria. | m | MEAN |
| SECONDARY | Change of World Health Organization- Functional Class (WHO-FC) From Baseline at 24 Weeks | baseline, 24 weeks | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed paticipants may vary due to missing data for specific outcome measures. The per-protocol set is identical to the intention-to-treat set, as no major protocol deviations occurred and all participants met the predefined eligibility criteria. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Change of World Health Organization- Functional Class (WHO-FC) From Baseline at 12 Weeks | baseline, 12 weeks | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed paticipants may vary due to missing data for specific outcome measures. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Change in Quality of Life (QoL) From Baseline at 24 Weeks | baseline, 24 weeks | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed paticipants may vary due to missing data for specific outcome measures. The per-protocol set is identical to the intention-to-treat set, as no major protocol deviations occurred and all participants met the predefined eligibility criteria. | scores on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline at 24 Weeks | baseline, 24 weeks | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed paticipants may vary due to missing data for specific outcome measures. The per-protocol set is identical to the intention-to-treat set, as no major protocol deviations occurred and all participants met the predefined eligibility criteria. | percent predicted | MEAN |
| OTHER_PRE_SPECIFIED | Change in Total Lung Capacity (TLC) From Baseline at 24 Weeks | baseline, 24 weeks | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed paticipants may vary due to missing data for specific outcome measures. The per-protocol set is identical to the intention-to-treat set, as no major protocol deviations occurred and all participants met the predefined eligibility criteria. | percent predicted | MEAN |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 outcomesResults by group88
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change of Pulmonary Vascular Resistance (PVR) | Riociguat | -0.69 | Standard Deviation 0.60 | WU | |
| Change of Pulmonary Vascular Resistance (PVR) | Placebo | 0.89 | Standard Deviation 3.29 | WU | |
| Change of Cardiac Index (CI) at Rest From Baseline at 24 Weeks | Riociguat | 0.21 | Standard Deviation 0.54 | l/min/m2 | |
| Change of Cardiac Index (CI) at Rest From Baseline at 24 Weeks | Placebo | -0.07 | Standard Deviation 0.40 | l/min/m2 | |
| Change of Total Pulmonary Resistance (TPR) From Baseline at 24 Weeks | Riociguat | 0.51 | Standard Deviation 1.18 | mmHg·min/L | |
| Change of Total Pulmonary Resistance (TPR) From Baseline at 24 Weeks | Placebo | -0.21 | Standard Deviation 0.82 | mmHg·min/L | |
| Change of Diffusion Capacity of the Lung (DLCO) From Baseline at 24 Weeks | Riociguat | 1.16 | Standard Deviation 6.40 | percent predicted | |
| Change of Diffusion Capacity of the Lung (DLCO) From Baseline at 24 Weeks | Placebo | 0.09 | Standard Deviation 7.40 | percent predicted | |
| Change in 6-minute Walking Distance (6MWD) | Riociguat | 23 | Standard Deviation 56.41 | m | |
| Change in 6-minute Walking Distance (6MWD) | Placebo | 24 | Standard Deviation 43.58 | m |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Riociguat | 17 | |
| Overall Study | STARTED | Placebo | 18 | |
| Overall Study | Visit 2 | Riociguat | 13 | |
| Overall Study | Visit 2 | Placebo | 14 | |
| Overall Study | Visit 3 | Riociguat | 16 | |
| Overall Study | Visit 3 | Placebo | 16 | |
| Overall Study | COMPLETED | Riociguat | 16 | |
| Overall Study | COMPLETED | Placebo | 16 | |
| Overall Study | NOT COMPLETED | Riociguat | 1 | |
| Overall Study | NOT COMPLETED | Placebo | 2 |
Source ClinicalTrials.gov
Adverse events52
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Riociguat | 5 | 17 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 4 | 18 | |
| other | Bloating | Gastrointestinal disorders | Riociguat | 0 | 17 | |
| other | Bloating | Gastrointestinal disorders | Placebo | 2 | 18 | |
| other | Emesis | Gastrointestinal disorders | Riociguat | 2 | 17 | |
| other | Emesis | Gastrointestinal disorders | Placebo | 2 | 18 | |
| other | Diarrhea | Gastrointestinal disorders | Riociguat | 3 | 17 | |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 2 | 18 | |
| other | Flatulence | Gastrointestinal disorders | Riociguat | 1 | 17 | |
| other | Flatulence | Gastrointestinal disorders | Placebo | 1 | 18 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Riociguat | 0 | 17 |
| Total, all-cause mortality | Placebo | 0 | 18 |
| Total, other adverse events | Riociguat | 16 | 17 |
| Total, other adverse events | Placebo | 16 | 18 |
| Total, serious adverse events | Riociguat | 2 | 17 |
| Total, serious adverse events | Placebo | 1 | 18 |
Source ClinicalTrials.gov
Papers6
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Riociguat vs Placebo: deaths from any cause | Trial comparisons |
| Riociguat vs Placebo: serious adverse events | Trial comparisons |
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/NCT05339087
GET https://conductscience.org/api/trials/v1/NCT05339087/registered?page=2