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Non-Invasive Cardiac Monitoring for Pulmonary Hypertension

N/A

Waitlist Available

Led By Sonia Jasuja, M.D.

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with a confirmed diagnosis or suspected diagnosis of pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension (CTEPH) prior to initiation or change in therapy.

PAH or CTEPH patients undergoing right heart catheterization (RHC) as part of their standard of care.

Must not have

BMI < 20 or BMI > 35.

Height less than 120 cm.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is researching new ways to measure risk and response to treatment in patients with PAH or CTEPH without invasive procedures. It will use non-invasive methods to measure cardiac output and stroke volume over the course of 1 year.

Who is the study for?

This trial is for adults over 18 with confirmed or suspected pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension (CTEPH). They must be undergoing a right heart catheterization as standard care and able to consent. It's not suitable for those with extreme body weights, certain heart valve issues, atrial fibrillation, or end-stage renal disease.

What is being tested?

The study tests non-invasive methods to measure cardiac output and stroke volume in PAH/CTEPH patients at UCLA Medical Center. It aims to see if these measurements can help assess risk and monitor treatment response without invasive procedures. Participants will have follow-ups every three months for one year.

What are the potential side effects?

Since the trial involves non-invasive measurement techniques, significant side effects are not expected. However, routine risks associated with right heart catheterization may apply but are part of standard care rather than specific to this study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have or might have high blood pressure in the lungs before starting or changing treatment.

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I am a patient with PAH or CTEPH and will have a heart catheter test.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My BMI is either below 20 or above 35.

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I am shorter than 120 cm.

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I have been diagnosed with atrial fibrillation, valve issues, or severe kidney disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Bronchial Provocation Tests

cardiac index (CI)

Cardiac Output

+4 more

Secondary study objectives

Nesiritide

World Health Organization (WHO)/New York Heart Association Functional Class (FC)

six-minute walk distance (6MWD)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Patients diagnosed with PAH or CTEPHExperimental Treatment1 Intervention

Patients with a confirmed diagnosis or suspected diagnosis of pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension (CTEPH) prior to initiation or change in therapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Non-invasive hemodynamic measurements

2018

N/A

~120

0 / 6Eligibility criteria met