The Expression and Significance of MiRNA

NCT00806312 | Completed

• 1 other identifier: 2008H0070
• Study Type: observational
• Target: 207
• Locations: 1 country
• Sites: 1

Brief Summary

It is not always known what causes PAH or what the best treatment is. The doctors doing this study would like to understand more about why some people develop PAH and other do not. They also would like to learn more about which treatments might help PAH and which people might respond better to treatments. Doctors think that testing certain substances found in blood cells might help answer these questions. These substances are normally released by our bodies to protect us from infection and to tell the difference between normal and foreign substances in our body. Finally, a new test will study very small molecules called microRNA that control how our genes are expressed. This study is being done to see if blood samples can be tested to determine who might develop PAH, how well drugs will work to treat PAH and to learn more about the development of PAH.

Conditions

Pulmonary Arterial Hypertension

Keywords

MiRNA; pulmonary arterial hypertension

Outcome Measures

Primary Outcomes (1)

• evaluate if miRNa profile and markers of inflammation in patients with PAH. These profiles may enable us differentiate patients that have PAH. This may assist in predicting response to therapy and enable us to optimize their treatment. may also shed s

  end of study

Study Arms (2)

1 PAH

Patients who are ≥ 18 years of age, not pregnant, and undergoing right heart catheterization for PAH diagnosis as part of their clinical care will be approached for consent and participation in this study.

2. Control

Patients who present with symptoms of PAH and whose clinical right heart catheterization doesn't support this diagnosis will be enrolled as control subjects.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We expect to enroll 200 patients, who have been referred to the Pulmonary Hypertension Clinic at the Ohio State University Medical Center, in this study. Patients who are ≥ 18 years of age, not pregnant, and undergoing right heart catheterization for PAH diagnosis as part of their clinical care will be approached for consent and participation in this study.

You may qualify if:

• ≥ 18 years of age
• Not pregnant
• Undergoing right heart catheterization for PAH diagnosis

You may not qualify if:

• Pregnant

Sponsors & Collaborators

• Megan Ballinger: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Namita Sood, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: December 9, 2008
• First Posted: December 10, 2008
• Study Start: July 1, 2008
• Primary Completion: August 16, 2018
• Study Completion: August 16, 2018
• Last Updated: November 2, 2021

Record last verified: 2021-10

Locations

US (1)