NCT01783093

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
209

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 4, 2013

Completed
Last Updated

February 4, 2013

Status Verified

January 1, 2013

Enrollment Period

3.1 years

First QC Date

August 17, 2011

Last Update Submit

January 31, 2013

Conditions

Sickle Cell AnemiaPulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to 20 years

Study Arms (1)

Sickle cell and pulmonary hypertension

Other: Data Collection

Interventions

Data CollectionOTHER

Collection of data from existing medical records

Sickle cell and pulmonary hypertension

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University Medical Center

Columbus, Ohio, 43221, United States

Location

Related Publications (5)

  • 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.

    PMID: 14985486BACKGROUND

  • 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.

    PMID: 19020327BACKGROUND

  • 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.

    PMID: 19415728BACKGROUND

  • 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.

    PMID: 15483284BACKGROUND

  • 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.

    PMID: 17724699BACKGROUND

MeSH Terms

Conditions

Anemia, Sickle CellHypertension, Pulmonary

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Namita Sood, M.D.

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 17, 2011

First Posted

February 4, 2013

Study Start

December 1, 2009

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

February 4, 2013

Record last verified: 2013-01

Locations

US(1)