Noninvasive Cardiac Output Measurements in Patients With Pulmonary

Status Withdrawn

Clinical Trial Summary

Subjects in this study have been diagnosed with pulmonary hypertension (PH) and their doctors have referred them for a right heart catheterization (RHC). Heart catheterization involves inserting an IV (a needle with a small tube) into a vein in the neck. A long, narrow tube, called a catheter, is guided through the IV into the blood vessel and guided to the heart (sometimes this procedure can be done through a vein in the groin instead). Once the catheter is in place, small instruments can be inserted into the catheter to measure the pressures in different areas of the heart. These measurements can help the doctor diagnose possible problems with the heart functioning.

The purpose of this study is to evaluate the measurements provided by a device, called Noninvasive Cardiac Output Monitoring (NICOM). The NICOM device is non-invasive which means the investigators do not have to go inside the body to obtain the heart pressure measurements. While the device has been approved for use in any patient, it remains possible that patients with PH will have differences in the way the device calculates measurements. In this study, the investigators will compare the in-the-body (right heart catheterization) measurements to the non-invasive, outside-body measurements provided by the NICOM device to evaluate any differences.

The NICOM device is approved by the US Food and Drug Administration (FDA) to measure heart pressures. This device is usually used when a patient can't undergo a right heart catheterization. In this study, the investigators are using the device to gather heart pressure measurements for research during the right heart catheterization procedure that is scheduled as part of the patients' normal, routine care. The research data is being used to devise better, less invasive ways to assess disease severity, track disease progression and evaluate response to therapy. The NICOM device is made by Cheetah Medical.

Clinical Trial Description

n/a

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01275690
Study type	Observational
Source	University of Chicago
Contact
Status	Withdrawn
Phase	N/A
Start date	May 2010
Completion date	May 2014

View Details

See also
Status	Clinical Trial	Phase
Withdrawn	`NCT01950585` - Hydroxyurea in Pulmonary Arterial Hypertension	Early Phase 1
Completed	`NCT00527163` - Role of Nitric Oxide in Malaria
Completed	`NCT03649932` - Enteral L Citrulline Supplementation in Preterm Infants - Safety, Efficacy and Dosing	Phase 1
Recruiting	`NCT04554160` - Arrhythmias in Pulmonary Hypertension Assessed by Continuous Long-term Cardiac Monitoring
Enrolling by invitation	`NCT03683186` - A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension	Phase 3
Completed	`NCT01894035` - Non-interventional Multi-center Study on Patients Under Routine Treatment of Pulmonary Arterial Hypertension (PAH) With Inhaled Iloprost Using I-Neb as a Device for Inhalation
Not yet recruiting	`NCT04083729` - Persistent Pulmonary Hypertension After Percutaneous Mitral Commissurotomy	N/A
Completed	`NCT02821156` - Study on the Use of Inhaled NO (iNO)	N/A
Terminated	`NCT02246348` - Evaluating Lung Doppler Signals in Patients With Systemic Sclerosis (SSc)	N/A
Completed	`NCT02216279` - Phase-II Study of the Use of PulmoBind for Molecular Imaging of Pulmonary Hypertension	Phase 2
Terminated	`NCT02243111` - Detecting Pulmonary Arterial Hypertension (PAH) in Patients With Systemic Sclerosis (SSc) by Ultrasound	N/A
Recruiting	`NCT01913847` - Safety and Efficacy Study of HGP1207 in Patients With Pulmonary Hypertension	Phase 3
Completed	`NCT06240871` - Contrast Enhanced PA Pressure Measurements
Completed	`NCT01615484` - Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability	N/A
Completed	`NCT02377934` - Evaluation of Radiation Induced Pulmonary Hypertension Using MRI in Stage III NSCLC Patients Treated With Chemoradiotherapy. A Pilot Study
Recruiting	`NCT01091012` - Effectiveness of the Vasodilator Test With Revatio, Made in Patients With Acute Pulmonary Hypertension	Phase 3
Completed	`NCT01463514` - Noninvasive Determination of Cerebral Tissue Oxygenation in Pulmonary Hypertension	N/A
Completed	`NCT01484899` - Smoking: a Risk Factor for Pulmonary Arterial Hypertension?	N/A
Completed	`NCT02275793` - The Regulation of Pulmonary Vascular Resistance in Patients With Heart Failure
Completed	`NCT00739375` - The Effect of Blood Flow in the Maturing Arteriovenous Access for Hemodialysis on the Development of Pulmonary Hypertension.	Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Noninvasive Cardiac Output Measurements in Patients With Pulmonary Hypertension Undergoing Right Heart Catheterization With Acute Vasodilator Testing

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms