Clinical trial NCT01783093: Tricuspid Regurgitant Jet Velocity as an Independent Marker for Mortality in Sickle Cell Anemia
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sickle Cell Anemia
Pulmonary Hypertension
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2013-02-04
Enrollment: 209
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients records will be extracted from the complete medical record at OSUMC

Brief 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. 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.


Eligibility 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.

Primary outcomes:
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.
timeFrame: Up to 20 years
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Namita Sood, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.