Trial · NCT00872170
Sildenafil to Improve Exercise Capacity in People With Thalassemia and Pulmonary Hypertension
NCT00872170, Phase 2, Phase 3, Completed, Carelon Research; results first posted 2014-02-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Sildenafil to Improve Exercise Capacity in People With Thalassemia and Pulmonary Hypertension. Trials, record NCT00872170. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00872170
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sildenafil to Improve Exercise Capacity in People With Thalassemia and Pulmonary Hypertension
- NCT number
- NCT00872170
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 27 participants, actual
- Lead sponsor
- Carelon Research
- Conditions
- Thalassemia, Hypertension, Pulmonary
- Interventions
- Sildenafil
- First posted
- 2009-03-31
- Last updated
- 2014-02-21
- Results first posted
- 2014-02-21
- Limitations and caveats
- Of 14 patients in the Sildenafil arm, 4 patients with discrepant TRVs between the local site, core lab and NHLBI readings were excluded for the main analyses.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Six-minute Walk Test (6MWT) Distance From Baseline to Week 12 Among Sildenafil Group | Baseline and Week 12 | Change in six-minute walk test (6MWT) distance was calculated as 6MWT at week 12 minus 6MWT at baseline. |
| Secondary | Change in Tricuspid Regurgitant Jet Velocity (TRV) From Baseline to Week 12 Among Sildenafil Group | Baseline and Week 12 | Change in tricuspid regurgitant jet velocity (TRV) was calculated as TRV at week 12 minus TRV at baseline. The TRV provides an estimate of pulmonary artery pressure. |
| Secondary | Change in Echo Left Ventricular End Systolic Volume (LVESV) From Baseline to Week 12 Among Sildenafil Group | Baseline and Week 12 | Change in echo left ventricular end systolic volume (LVESV) was calculated as LVESV at week 12 minus LVESV at baseline. |
| Secondary | Change in Echo Left Ventricular End Diastolic Volume (LVEDV) From Baseline to Week 12 Among Sildenafil Group | Baseline and Week 12 | Change in echo left ventricular end diastolic volume (LVEDV) was calculated as LVEDV at week 12 minus LVEDV at baseline. |
| Secondary | Change in Plasma Arginine From Baseline to Week 12 Among Sildenafil Group | Baseline and Week 12 | Change in Plasma Arginine was calculated as Plasma Arginine at week 12 minus Plasma Arginine at baseline. |
| Secondary | Change in Red Blood Cell (RBC) Arginine From Baseline to Week 12 Among Sildenafil Group | Baseline and Week 12 | Change in Red Blood Cell (RBC) Arginine was calculated as Red Blood Cell (RBC) Arginine at week 12 minus Red Blood Cell (RBC) Arginine at baseline. |
| Secondary | Change in Soluble Platelet Selectin (sP-SELECTIN) From Baseline to Week 12 Among Sildenafil Group | Baseline and Week 12 | Change in Soluble platelet selectin (sP-SELECTIN) was calculated as sP-SELECTIN at week 12 minus sP-SELECTIN at baseline. |
| Secondary | Change in Lactate Dehydrogenase (LDH) From Baseline to Week 12 Among Sildenafil Group | Baseline and Week 12 | Change in Lactate dehydrogenase (LDH) was calculated as LDH at week 12 minus LDH at baseline. |
| Secondary | Change in Cell Free Hemoglobin From Baseline to Week 12 Among Sildenafil Group | Baseline and Week 12 | Change in Cell Free Hemoglobin was calculated as Cell Free Hemoglobin at week 12 minus Cell Free Hemoglobin at baseline. |
| Secondary | Change in Arginase Concentration From Baseline to Week 12 Among Sildenafil Group | Baseline and Week 12 | Change in Arginase concentration was calculated as Arginase concentration at week 12 minus Arginase concentration at baseline. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Six-minute Walk Test (6MWT) Distance From Baseline to Week 12 Among Sildenafil Group | Baseline and Week 12 | Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and 2 patients who had no 6MWT at 12 weeks were excluded. Patients in control group were only assessed at baseline. Therefore, 8 Sildenafil and 0 control patients were used. | meters | MEAN |
| SECONDARY | Change in Tricuspid Regurgitant Jet Velocity (TRV) From Baseline to Week 12 Among Sildenafil Group | Baseline and Week 12 | Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used. | m/s | MEAN |
| SECONDARY | Change in Echo Left Ventricular End Systolic Volume (LVESV) From Baseline to Week 12 Among Sildenafil Group | Baseline and Week 12 | Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used. | ml | MEAN |
| SECONDARY | Change in Echo Left Ventricular End Diastolic Volume (LVEDV) From Baseline to Week 12 Among Sildenafil Group | Baseline and Week 12 | Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used. | ml | MEAN |
| SECONDARY | Change in Plasma Arginine From Baseline to Week 12 Among Sildenafil Group | Baseline and Week 12 | Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used. | µM | MEAN |
| SECONDARY | Change in Red Blood Cell (RBC) Arginine From Baseline to Week 12 Among Sildenafil Group | Baseline and Week 12 | Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used. | µM | MEAN |
| SECONDARY | Change in Soluble Platelet Selectin (sP-SELECTIN) From Baseline to Week 12 Among Sildenafil Group | Baseline and Week 12 | Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used. | ng/ml | MEAN |
| SECONDARY | Change in Lactate Dehydrogenase (LDH) From Baseline to Week 12 Among Sildenafil Group | Baseline and Week 12 | Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and 2 patients who had no LDH at 12 weeks were excluded. Patients in control group were only assessed at baseline. Therefore, 8 Sildenafil and 0 control patients were used. | U/L | MEAN |
| SECONDARY | Change in Cell Free Hemoglobin From Baseline to Week 12 Among Sildenafil Group | Baseline and Week 12 | Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used. | ug/ml | MEAN |
| SECONDARY | Change in Arginase Concentration From Baseline to Week 12 Among Sildenafil Group | Baseline and Week 12 | Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used. | ng/ml | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Six-minute Walk Test (6MWT) Distance From Baseline to Week 12 Among Sildenafil Group | Sildenafil | -1.38 | Standard Error 16.01 | meters | |
| Change in Tricuspid Regurgitant Jet Velocity (TRV) From Baseline to Week 12 Among Sildenafil Group | Sildenafil | -0.45 | Standard Error 0.18 | m/s | |
| Change in Echo Left Ventricular End Systolic Volume (LVESV) From Baseline to Week 12 Among Sildenafil Group | Sildenafil | -3.82 | Standard Error 0.98 | ml | |
| Change in Echo Left Ventricular End Diastolic Volume (LVEDV) From Baseline to Week 12 Among Sildenafil Group | Sildenafil | -7.89 | Standard Error 2.71 | ml | |
| Change in Plasma Arginine From Baseline to Week 12 Among Sildenafil Group | Sildenafil | 31.77 | Standard Error 15.81 | µM | |
| Change in Red Blood Cell (RBC) Arginine From Baseline to Week 12 Among Sildenafil Group | Sildenafil | 3.67 | Standard Error 1.45 | µM | |
| Change in Soluble Platelet Selectin (sP-SELECTIN) From Baseline to Week 12 Among Sildenafil Group | Sildenafil | 121.13 | Standard Error 57.56 | ng/ml | |
| Change in Lactate Dehydrogenase (LDH) From Baseline to Week 12 Among Sildenafil Group | Sildenafil | 23.37 | Standard Error 35.98 | U/L | |
| Change in Cell Free Hemoglobin From Baseline to Week 12 Among Sildenafil Group | Sildenafil | -67.60 | Standard Error 48.03 | ug/ml | |
| Change in Arginase Concentration From Baseline to Week 12 Among Sildenafil Group | Sildenafil | -17.06 | Standard Error 16.25 | ng/ml |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sildenafil | 14 | |
| Overall Study | STARTED | Control | 13 | |
| Overall Study | COMPLETED | Sildenafil | 13 | |
| Overall Study | COMPLETED | Control | 13 | |
| Overall Study | NOT COMPLETED | Sildenafil | 1 | |
| Overall Study | NOT COMPLETED | Control | 0 |
Source ClinicalTrials.gov
Adverse events34
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 | Fatigue | General disorders | Sildenafil | 1 | 14 | 1 |
| other | Fatigue | General disorders | Control | 0 | 0 | 0 |
| other | Photophobia | Eye disorders | Sildenafil | 1 | 14 | 1 |
| other | Photophobia | Eye disorders | Control | 0 | 0 | 0 |
| other | Headache | Nervous system disorders | Sildenafil | 5 | 14 | 6 |
| other | Headache | Nervous system disorders | Control | 0 | 0 | 0 |
| other | Vision/color disturbance | Eye disorders | Sildenafil | 2 | 14 | 3 |
| other | Vision/color disturbance | Eye disorders | Control | 0 | 0 | 0 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Sildenafil | 1 | 14 | 1 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Control | 0 | 0 | 0 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sildenafil | ||
| Total, all-cause mortality | Control | ||
| Total, other adverse events | Sildenafil | 11 | 14 |
| Total, other adverse events | Control | 0 | 0 |
| Total, serious adverse events | Sildenafil | 2 | 14 |
| Total, serious adverse events | Control | 0 | 0 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23585527 | RESULT |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01HL065238 | Thalassemia Clinic Research Network | MCKINLAY, SONJA M | NEW ENGLAND RESEARCH INSTITUTES, INC. | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2000 to 2009 |
Source NIH RePORTER
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/NCT00872170
GET https://conductscience.org/api/trials/v1/NCT00872170/events?page=2