Tricuspid Regurgitant Jet Velocity as an Independent Marker for Mortality in Sickle Cell Anemia

NCT ID: NCT01783093

Last Updated: 2013-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

209 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2013-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Sickle Cell Anemia Pulmonary Hypertension

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Sickle cell and pulmonary hypertension

Data Collection

Intervention Type OTHER

Collection of data from existing medical records

Interventions

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Data Collection

Collection of data from existing medical records

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Namita Sood

OTHER

Sponsor Role lead

Responsible Party

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Namita Sood

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Namita Sood, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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The Ohio State University Medical Center

Columbus, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 14985486 (View on PubMed)

Gladwin 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.

Reference Type BACKGROUND
PMID: 19020327 (View on PubMed)

Ballas 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.

Reference Type BACKGROUND
PMID: 19415728 (View on PubMed)

Farber HW, Loscalzo J. Pulmonary arterial hypertension. N Engl J Med. 2004 Oct 14;351(16):1655-65. doi: 10.1056/NEJMra035488. No abstract available.

Reference Type BACKGROUND
PMID: 15483284 (View on PubMed)

De 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.

Reference Type BACKGROUND
PMID: 17724699 (View on PubMed)

Other Identifiers

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2009H0269

Identifier Type: -

Identifier Source: org_study_id

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