The Expression and Significance of MiRNA

The Expression and Significance of miRNA Profile and Markers of Inflammation in Patients With Pulmonary Arterial Hypertension

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Arterial Hypertension

Detailed Description

You will be asked to donate blood when you have your right heart catheterization and also at the 3-4 month follow-up visit. The amount of blood collected during your heart catheterization is about 20cc (about 4 teaspoons). This blood is discarded as part of the clinical catheterization procedure, but we are asking that we use it for this research study. Then, at the follow-up right heart catheterization, you will be asked to donate 20 cc (which is about 4 teaspoons) of blood.

If the second right heart is not required for clinical purposes then you will be asked to give a blood sample during your 3-4 month follow up clinic visit.

If you require an additional right heart catheterization, within one year, we will ask that you donate additional samples at the subsequent RHC.

Other data collected as part of your clinical care, such as medical history, chest x-ray (picture of your lungs), echocardiogram (picture of your heart), ventilation perfusion scan (determines how much blood goes to your lungs), chest CT (thin pictures of my lungs as slices), pulmonary function tests (breathing tests), and lab blood tests, will be used as part of this research.

• Study Type: Observational
• Enrollment (Actual): 207

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnant

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Megan Ballinger
• Investigators: Principal Investigator: Namita Sood, MD, Ohio State University

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): August 16, 2018
• Study Completion (Actual): August 16, 2018

Study Registration Dates

• First Submitted: December 9, 2008
• First Submitted That Met QC Criteria: December 9, 2008
• First Posted (Estimate): December 10, 2008

Study Record Updates

• Last Update Posted (Actual): November 2, 2021
• Last Update Submitted That Met QC Criteria: October 27, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: pulmonary arterial hypertension; MiRNA
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension, Pulmonary; Hypertension; Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension
• Other Study ID Numbers: 2008H0070