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Study Detail

Study ID 1002
Name Treatment of Pulmonary Hypertension and Sickle Cell Disease With Sildenafil Therapy
Contact Email biolincc@imsweb.com
Acronym walk-PHaSST
Period 2007 – 2009
Design Clinical Trial
Study PI Mark T. Gladwin
Institution Multiple institutes
URL https://biolincc.nhlbi.nih.gov/studies/walk_phasst/
CTGovID https://clinicaltrials.gov/ct2/show/NCT00492531
Funding Agency NHLBI
Grant Number HHSN268200617182C
Overview The Walk-PHaSST study explored whether sildenafil, a medication used to lessen symptoms of pulmonary hypertension, is also effective and safe for those with sickle cell disease who develop pulmonary hypertension.
Focus Areas 1. 6-Minute Walk
2. Sickle Cell Anemia
3. Sildenafil/Viagra
4. Tricuspid Regurgitant Velocity
5. Sickle Cell Disease
6. Pulmonary Hypertension
Outcomes 1. Change in Exercise Capacity as Assessed by 6 Minute Walk. [ Time Frame: Baseline to week 16/Imputed last visit. ]
2. Change From Baseline in Pulmonary Hypertension at Week 16 as Assessed by Tricuspid Regurgitant Jet Velocity [ Time Frame: 16 weeks ]
3. Borg Dyspnea Score [ Time Frame: baseline to 16 weeks ]
4. Brain Natriuretic Peptide(BNP)Levels. [ Time Frame: 16 weeks ]
Data Location BioLINCC, BioData Catalyst
Biospecimen Available N/A
Data Consent Data sharing via BioLINCC; Consent restricts use of data to research related to sickle cell disease.
Biospecimen Consent NA
Contact Consent NA
Genomic Data No
Age Range 12-70
No. Participants 720
Inclusion Criteria 1. Screening- Males or females, greater than or equal to 12 years of age and less than or equal to 70 years of age.
2. Screening - Diagnosis of sickle cell disease (including, but not limited to SS, SC, SD, or S-beta zero thalassemia).
3. Screening - Provision of informed consent and, where applicable, assent.
4. Participants with mild to severe pulmonary hypertension, defined as Doppler echocardiography peak tricuspid regurgitation velocity (TRV) of = 2.7 m/s, and a six minute walk distance of 150-500 meters, were further eligible for the interventional trial.
Exclusion Criteria 1. Current pregnancy or lactation.
2. Any one of the following medical conditions:Stroke within the last six weeks.Diagnosis of pulmonary embolism within the last three months.History of retinal detachment or retinal hemorrhage in the last 6 months.Non-arteritic anterior ischemic optic neuropathy (NAION) in one or both eyes.History of sustained priapism requiring medical or surgical treatment, unless currently impotent or on transfusion program within the last two years.Any unstable (chronic or acute) condition that in the opinion of the investigator will prevent completion of the study.
3. Subjects taking nitrate-based vasodilators (including, but not limited to nicorandil [available in the UK only]), prostacyclin (inhaled, subcutaneous or intravenous) or endothelin antagonists. Subjects taking calcium channel blockers will be allowed to participate if they are on a stable dose for greater than or equal to 3 months.
4. Left ventricular ejection fraction (LVEF) less than 40 percent or clinically significant ischemic, valvular or constrictive heart disease: LVEF less than 40 percent or SF less than 22 percent.
5. Subjects in other research studies with investigational drugs (with the exception of hydroxyurea) unless the other trial has been approved by the walk-PHaSST Executive Committee for co-participation.
6. Acute or chronic impairment (other than dyspnea), limiting the ability to comply with study requirements (in particular with 6MWT), e.g., angina pectoris, intermittent claudication, symptomatic hip osteonecrosis.
7. Tonsillectomies for sleep apnea within 3 months prior to randomization. Active therapy for pulmonary hypertension, including prostacyclin analog, endothelin-1 antagonist, or PDE-5 inhibitor.
8. Protease inhibitor therapy for HIV treatment Subjects taking potent CYP3A4 inhibitor therapy (e.g., itraconazole, ritonavir, ketoconazole) Subjects who are anticoagulated and have proliferative retinopathy (unless they have had ophthalmologist recommended intervention (e.g., phototherapy) or have been cleared by the ophthalmologist to participate in the study.
9. Subjects with systolic blood pressure greater than or equal to 140 mmHg OR diastolic blood pressure greater than or equal to 90 mmHg.
Data ElementVariables
ASCQ-Me Pain Episode
ASCQ-Me Pain Impact
ASCQ-Me Stiffness Impact
Brief Pain Inventory (BPI) FOOTL
FOOTM
FOOTR
IQ2LLEGM
Q1
Q2ABDOC
Q2ABDOL
Q2ABDOM
Q2ABDOR
Q2BUTTL
Q2BUTTM
Q2BUTTR
Q2CHSTC
Q2CHSTL
Q2CHSTM
Q2CHSTR
Q2ELBL
Q2ELBM
Q2ELBR
Q2GEN
Q2GENM
Q2HANDL
Q2HANDM
Q2HANDR
Q2HEADC
Q2HEADL
Q2HEADM
Q2HEADR
Q2KNEEL
Q2KNEEM
Q2KNEER
Q2LARML
Q2LARMM
Q2LARMR
Q2LBCKC
Q2LBCKL
Q2LBCKM
Q2LBCKR
Q2LLEGL
Q2LLEGR
Q2NECK
Q2NECKM
Q2SHLDL
Q2SHLDM
Q2SHLDR
Q2UARML
Q2UARMM
Q2UARMR
Q2UBCKC
Q2UBCKL
Q2UBCKM
Q2UBCKR
Q2ULEGL
Q2ULEGM
Q2ULEGR
Q3
Q4
Q5
Q6
Q7
Q8
Q9A
Q9B
Q9C
Q9D
Q9E
Q9F
Q9G
Chronic Pain
PROMIS Neuropathic Pain Quality
PROMIS Nociceptive Pain Quality
PROMIS Pain Behavior
PROMIS Pain Interference
Data ElementVariables
6-Minute Walk Test AOPOST
AOPRE
BRGPOST
CLASS
DEVICE
DIAPOST
DIAPRE
DIST
DRUGDA
DRUGHH
DRUGMM
DRUGMO
DRUGYR
FRPOST
FRPRE
FRWALK
HRPOST
HRPRE
OSPOST
OSPRE
STARTHH
STARTMM
SUBSTOP
SYSPOST
SYSPRE
USE02
PROMIS Physical Functioning
Tanner Stage
Data ElementVariables
ASCQ-Me SCD Medical History Checklist
ASCQ-Me Sexual Health
Child Health Questionnaire (CHQ)
Ladder of Life
Pediatric Quality of Life Inventory Child Report (ages 13-18) EMOFC1
EMOFC2
EMOFC3
EMOFC4
EMOFC5
PHYFC1
PHYFC2
PHYFC3
PHYFC4
PHYFC5
PHYFC6
PHYFC7
PHYFC8
SCHFC1
SCHFC2
SCHFC3
SCHFC4
SCHFC5
SOCFC1
SOCFC2
SOCFC3
SOCFC4
Pediatric Quality of Life Inventory Child Report (ages 8-12) EMOFC1
EMOFC2
EMOFC3
EMOFC4
EMOFC5
PHYFC1
PHYFC2
PHYFC3
PHYFC4
PHYFC5
PHYFC6
PHYFC7
PHYFC8
SCHFC1
SCHFC2
SCHFC3
SCHFC4
SCHFC5
SOCFC1
SOCFC2
SOCFC3
SOCFC4
SOCFC5
Pediatric Quality of Life Inventory Parent Report for Child (ages 13-18) EMOFP1
EMOFP2
EMOFP3
EMOFP4
EMOFP5
PHYFP1
PHYFP2
PHYFP3
PHYFP4
PHYFP5
PHYFP6
PHYFP7
PHYFP8
SCHFP1
SCHFP2
SCHFP3
SCHFP4
SCHFP5
SOCFP1
SOCFP2
SOCFP3
SOCFP4
SOCFP5
Pediatric Quality of Life Inventory Parent Report for Child (ages 8-12) EMOFP1
EMOFP2
EMOFP3
EMOFP4
EMOFP5
PHYFP1
PHYFP2
PHYFP3
PHYFP4
PHYFP5
PHYFP6
PHYFP7
PHYFP8
SCHFP1
SCHFP2
SCHFP3
SCHFP4
SCHFP5
SOCFP1
SOCFP2
SOCFP3
SOCFP4
SOCFP5
PROMIS Global Health
PROMIS Global Physical Health
PROMIS Self-Efficacy for Managing Medications and Treatment
SF-36 Health Survey SFQ1
SFQ10
SFQ11A
SFQ11B
SFQ11C
SFQ11D
SFQ2
SFQ3A
SFQ3B
SFQ3C
SFQ3D
SFQ3E
SFQ3F
SFQ3G
SFQ3H
SFQ3I
SFQ3J
SFQ4A
SFQ4B
SFQ4C
SFQ4D
SFQ5A
SFQ5B
SFQ5C
SFQ6
SFQ7
SFQ8
SFQ9A
SFQ9B
SFQ9C
SFQ9D
SFQ9E
SFQ9F
SFQ9G
SFQ9H
SFQ9I
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