Sickle Cell AnemiaNCT01783093
Tricuspid Regurgitant Jet Velocity as an Independent Marker for Mortality in Sickle Cell Anemia
An observational study of Sickle Cell Anemia and Pulmonary Hypertension, run by Namita Sood at 1 site in United States.
Trial summary
The purpose of this study is to evaluate patients with pulmonary hypertension and sickle cell disease who have had multiple echocardiograms. Previous studies have shown that an elevated tricuspid jet (TR) regurgitant velocity on echo in this population is a predictor of mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sickle Cell Anemia, Pulmonary Hypertension
- What is being tested?
- Data Collection
- How many people
- 209 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients records will be extracted from the complete medical record at OSUMC
To limit bias in this study all patients that with sickle cell anemia and pulmonary hypertension with the pre-specified data required will be included.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Medical Center
Columbus, Ohio, 43221
About this study
Official title: An Evaluation of Tricuspid Regurgitant Jet Velocity as an Independent Marker for Mortality in Patients With Sickle Cell Anemia: A Retrospective Data Review
The purpose of this study is to evaluate patients with pulmonary hypertension and sickle cell disease who have had multiple echocardiograms. Previous studies have shown that an elevated tricuspid jet (TR) regurgitant velocity on echo in this population is a predictor of mortality. This initial data only examined an isolated TR jet velocity. It was presumed that the mortality was related to pulmonary hypertension.
It is the aim of this study to retrospectively evaluate patients who have had multiple echocardiograms and to determine if patients who had either a normalization of their TR jet velocity on a subsequent echo or had no evidence of pulmonary hypertension on right heart catheterization had a similar mortality rate to those with persistently elevated TR jet velocity.
- Conditions
- Sickle Cell Anemia, Pulmonary Hypertension
- Being tested
- Data Collection
- Medical subject headings
- Anemia, Sickle Cell, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data CollectionOther
Collection of data from existing medical records
| Study group | Role | What they receive |
|---|---|---|
| Sickle cell and pulmonary hypertension | Not described Receives: Other: Data Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
A retrospective review on patients who have had multiple echocardiograms to determine if patients with a normalization of TR Jet Velocity have changes in risk of death compared with those who do not have normalization of TR Jet Velocity.
Any subject's who meet criteria and have multiple echocardiograms may be included.
Measured: Up to 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2013 (estimated)
- Study startDec 2009
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Namita Sood
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Namita Sood, Ohio State University
- Investigators
- Namita Sood, M.D., Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01783093
- Sponsor's protocol ID
- 2009H0269
- Status last verified
- Jan 2013
- First submitted
- 17 Aug 2011
- Last updated
- 4 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Gladwin MT, Sachdev V, Jison ML, Shizukuda Y, Plehn JF, Minter K, Brown B, Coles WA, Nichols JS, Ernst I, Hunter LA, Blackwelder WC, Schechter AN, Rodgers GP, Castro O, Ognibene FP. Pulmonary hypertension as a risk factor for death in patients with sickle cell disease. N Engl J Med. 2004 Feb 26;350(9):886-95. doi: 10.1056/NEJMoa035477.
PubMed 14985486Gladwin MT, Vichinsky E. Pulmonary complications of sickle cell disease. N Engl J Med. 2008 Nov 20;359(21):2254-65. doi: 10.1056/NEJMra0804411. No abstract available.
PubMed 19020327Ballas SK. The cost of health care for patients with sickle cell disease. Am J Hematol. 2009 Jun;84(6):320-2. doi: 10.1002/ajh.21443. No abstract available.
PubMed 19415728Farber HW, Loscalzo J. Pulmonary arterial hypertension. N Engl J Med. 2004 Oct 14;351(16):1655-65. doi: 10.1056/NEJMra035488. No abstract available.
PubMed 15483284De Castro LM, Jonassaint JC, Graham FL, Ashley-Koch A, Telen MJ. Pulmonary hypertension associated with sickle cell disease: clinical and laboratory endpoints and disease outcomes. Am J Hematol. 2008 Jan;83(1):19-25. doi: 10.1002/ajh.21058.
PubMed 17724699
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Tricuspid Regurgitant Jet Velocity as an Independent Marker for Mortality in Patients With Sickle Cell Anemia: A Retrospective Data Review
- ClinicalTrials.gov ID
- NCT01783093
- Acronym / sponsor ID
- 2009H0269
- Conditions
- Sickle Cell Anemia, Pulmonary Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Namita SoodUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 4 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate patients with pulmonary hypertension and sickle cell disease who have had multiple echocardiograms. Previous studies have shown that an elevated tricuspid jet (TR) regurgitant velocity on echo in this population is a predictor of mortality. This initial data only examined an isolated TR jet velocity. It was presumed that the mortality was related to pulmonary hypertension.
It is the aim of this study to retrospectively evaluate patients who have had multiple echocardiograms and to determine if patients who had either a normalization of their TR jet velocity on a subsequent echo or had no evidence of pulmonary hypertension on right heart catheterization had a similar mortality rate to those with persistently elevated TR jet velocity.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sickle cell and pulmonary hypertension | – | Other: Data Collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients records will be extracted from the complete medical record at OSUMC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data CollectionCollection of data from existing medical records | Other | Sickle cell and pulmonary hypertension |
Primary outcome
A retrospective review on patients who have had multiple echocardiograms to determine if patients with a normalization of TR Jet Velocity have changes in risk of death compared with those who do not have normalization of TR Jet Velocity.
Time frame: Up to 20 years
Any subject's who meet criteria and have multiple echocardiograms may be included.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2013.
- Background: PubMed 14985486Gladwin MT, Sachdev V, Jison ML, Shizukuda Y, Plehn JF, Minter K, Brown B, Coles WA, Nichols JS, Ernst I, Hunter LA, Blackwelder WC, Schechter AN, Rodgers GP, Castro O, Ognibene FP. Pulmonary hypertension as a risk factor for death in patients with sickle cell disease. N Engl J Med. 2004 Feb 26;350(9):886-95. doi: 10.1056/NEJMoa035477.
- Background: PubMed 19020327Gladwin MT, Vichinsky E. Pulmonary complications of sickle cell disease. N Engl J Med. 2008 Nov 20;359(21):2254-65. doi: 10.1056/NEJMra0804411. No abstract available.
- Background: PubMed 19415728Ballas SK. The cost of health care for patients with sickle cell disease. Am J Hematol. 2009 Jun;84(6):320-2. doi: 10.1002/ajh.21443. No abstract available.
- Background: PubMed 15483284Farber HW, Loscalzo J. Pulmonary arterial hypertension. N Engl J Med. 2004 Oct 14;351(16):1655-65. doi: 10.1056/NEJMra035488. No abstract available.
- Background: PubMed 17724699De Castro LM, Jonassaint JC, Graham FL, Ashley-Koch A, Telen MJ. Pulmonary hypertension associated with sickle cell disease: clinical and laboratory endpoints and disease outcomes. Am J Hematol. 2008 Jan;83(1):19-25. doi: 10.1002/ajh.21058.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Namita Sood, M.D. principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Anemia and Pulmonary Hypertension, run by Namita Sood at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A retrospective review on patients who have had multiple echocardiograms to determine if patients with a normalization of TR Jet Velocity have changes in risk of death compared with those who do not have normalization of TR Jet Velocity. (time frame: Up to 20 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01783093, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2013.