Sildenafil Therapy for Pulmonary Hypertension and Sickle Cell Disease
This study has been terminated.
(Subjects on drug were more likely to have severe pain crises requiring hospitalization.)
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00492531
First received: June 26, 2007
Last updated: June 3, 2011
Last verified: June 2011
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Results First Received: April 28, 2011
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment |
| Conditions: |
Sickle Cell Disease Pulmonary Hypertension |
| Interventions: |
Drug: Sildenafil Drug: Placebo |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| Subjects with Sickle cell hemoglobinopathy were recruited from 10 centers(9 in United States and 1 in United Kingdom) |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Sildenafil | Subjects received oral sildenafil 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated). |
| Placebo | Subjects received matching oral dose of placebo 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated). |
Participant Flow: Overall Study
| Sildenafil | Placebo | |
|---|---|---|
| STARTED | 37 | 37 |
| COMPLETED | 15 [1] | 14 [2] |
| NOT COMPLETED | 22 | 23 |
| Withdrawn(More than one reason selected) | 22 | 23 |
| [1] | Of 15 subjects who completed study, 13 were enrolled in Open label. |
|---|---|
| [2] | Of 14 subjects who completed study, 13 were enrolled in Open label. |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Sildenafil | Subjects received oral sildenafil 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated). |
| Placebo | Subjects received matching oral dose of placebo 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated). |
| Total | Total of all reporting groups |
Baseline Measures
| Sildenafil | Placebo | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
37 | 37 | 74 |
|
Age
[units: years] Mean ± Standard Deviation |
47 ± 13 | 44 ± 14 | 45 ± 13 |
|
Gender
[units: participants] |
|||
| Female | 23 | 23 | 46 |
| Male | 14 | 14 | 28 |
|
Ethnicity (NIH/OMB)
[units: Participants] |
|||
| Not Hispanic or Latino | 32 | 37 | 69 |
| Unknown or Not Reported | 5 | 0 | 5 |
|
Race (NIH/OMB)
[units: participants] |
|||
| Black or African American | 36 | 37 | 73 |
| Unknown or Not Reported | 1 | 0 | 1 |
|
6 minute walk
[1] [units: Meters] Mean ± Standard Deviation |
381 ± 75 | 386 ± 75 | 383 ± 75 |
|
Tricuspid regurgitant jet velocity (TRV)
[2] [units: m/s] Mean ± Standard Deviation |
3.0 ± 0.5 | 3.0 ± 0.3 | 3.0 ± 0.3 |
| [1] | The distance walked in six minute was used to assess the exercise capacity of the patient at baseline. |
|---|---|
| [2] | Tricuspid regurgitant jet velocity was measured by transthoracic Doppler Echocardiography. |
Outcome Measures
| 1. Primary: | Change in Exercise Capacity as Assessed by 6 Minute Walk. [ Time Frame: Baseline to week 16/Imputed last visit. ] |
| 2. Secondary: | Change From Baseline in Pulmonary Hypertension at Week 16 as Assessed by Tricuspid Regurgitant Jet Velocity [ Time Frame: 16 weeks ] |
| 3. Secondary: | Borg Dyspnea Score [ Time Frame: baseline to 16 weeks ] |
Hide Outcome Measure 3| Measure Type | Secondary |
|---|---|
| Measure Title | Borg Dyspnea Score |
| Measure Description | Borg dyspnea score was used to measure the level of severity of breathlessness perceived by the patient before and after 6 minute walk. The severity is measured on a 10 point scale with 0= nothing at all and 10=maximum severity of breathlessness. |
| Time Frame | baseline to 16 weeks |
| Safety Issue | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Sildenafil | Subjects received oral sildenafil 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated). |
| Placebo | Subjects received matching oral dose of placebo 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated). |
Measured Values
| Sildenafil | Placebo | |
|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
37 | 37 |
|
Borg Dyspnea Score
[units: Score on a scale] Mean ± Standard Deviation |
||
| Baseline | 2.5 ± 2.1 | 2.1 ± 2.0 |
| Week 6 | 3.4 ± 2.3 | 1.8 ± 1.3 |
| Week 10 | 2.7 ± 2.0 | 2.7 ± 1.7 |
| Week 16 | 2.0 ± 1.6 | 2.8 ± 2.4 |
No statistical analysis provided for Borg Dyspnea Score
| 4. Secondary: | Brain Natriuretic Peptide(BNP)Levels. [ Time Frame: 16 weeks ] |