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Assessing the Utility of Submaximal CPET in Treatment Management of PAH - Trial NCT05977933

Access comprehensive clinical trial information for NCT05977933 through Pure Global AI's free database. This phase not specified trial is sponsored by Shape Medical Systems, Inc. and is currently Not yet recruiting. The study focuses on Pulmonary Arterial Hypertension. Target enrollment is 550 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

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Trial Details
ClinicalTrials.gov โ€ข NCT05977933
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Assessing the Utility of Submaximal CPET in Treatment Management of PAH
Assessing the Utility of Shape Submaximal Cardiopulmonary Exercise Testing in Detecting, Diagnosis and Treatment Management of Pulmonary Arterial Hypertension.

Study Focus

Shape II CPET

Observational

device

Sponsor & Location

Shape Medical Systems, Inc.

Torrance,Denver,Jacksonville,Atlanta,Columbus,New York, United States of America

Timeline & Enrollment

N/A

Aug 25, 2023

Jul 30, 2025

550 participants

Primary Outcome

Demonstrate the Submaximal Cardiopulmonary exercise testing (Shape CPET) is an effective complementary tool in the resting echocardiogram for detection of Pulmonary Hypertension.,Demonstrate the percent change in submaximal Shape Cardiopulmonary exercise testing (Shape CPET) metrics and the 6 minute walk time distance (6MWTd)

Summary

Pulmonary hypertension (PH) is associated with worsening breathlessness and exercise
 capacity, right-heart failure, and adverse outcomes including increased mortality. Moreover,
 PH disease progression can be rapid; pharmaceutical intervention in early-stage Pulmonary
 Hypertension (PH) can improve symptoms and functional capacity, and delayed diagnosis and
 treatment of Pulmonary Hypertension (PH) likely reduces survival.

ICD-10 Classifications

Primary pulmonary hypertension
Other secondary pulmonary hypertension
Pulmonary heart disease and diseases of pulmonary circulation
Stenosis of pulmonary artery
Pulmonary heart disease, unspecified

Data Source

ClinicalTrials.gov

NCT05977933

Device Trial