Postural Changes During Right Heart Catheterization

NCT03089164 | Terminated

• 1 other identifier: 16-0554
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Hemodynamic measurements obtained during pulmonary artery catheterization are essential for the diagnosis and classification of pulmonary hypertension. Traditionally, right heart catheterization (RHC) is done in the supine position. Cardiac output is known to change significantly based on position, due to the effects of gravity on venous return. There has not been a systematic investigation into these postural effects on pulmonary arterial pressures nor their effect on the diagnosis of pulmonary hypertension. It is our intent to study the differences in measurements obtained during RHC when the patient is supine, seated, and standing.

Conditions

Pulmonary Hypertension; Right Heart Failure Due to Pulmonary Hypertension

Outcome Measures

Primary Outcomes (2)

• Measurement of mean PAP in three positions

  Mean pulmonary arterial pressure pressure (mPAP) will be measured in supine, sitting and standing positions in each subject during a single right heart catheterization procedure

  During a single right heart catheterization procedure (total time averaging around 30 minutes), about 5 minutes for each position will be needed to obtain each value

• Measurement of PCWP in three positions

  Pulmonary capillary wedge pressure (PCWP) will be measured in supine, sitting and standing positions in each subject during a single right heart catheterization procedure

  During a single right heart catheterization procedure (total time averaging around 30 minutes), about 5 minutes for each position will be needed to obtain each value

Interventions

Right heart catheterization DIAGNOSTIC_TEST

Each patient will have variables measured supine, sitting and standing positions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be a cohort of patients referred for right heart catheterization for workup of pulmonary arterial hypertension.

You may qualify if:

• All patients that are 18 years or older regardless of gender or race,
• are referred for RHC for evaluation of possible Pulmonary Arterial Hypertension (PAH)
• provide informed consent

You may not qualify if:

• Inability to obtain pulmonary artery pressure or PCWP

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Conditions

Hypertension, Pulmonary; Pulmonary Heart Disease

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Heart Diseases

Study Officials

• Hubert "Jimmy" Ford, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2017
• First Posted: March 24, 2017
• Study Start: May 1, 2017
• Primary Completion: January 29, 2018
• Study Completion: January 29, 2018
• Last Updated: June 27, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)