Pure Global AI
NCT05977933Not yet recruiting

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.
Shape Medical Systems, Inc.ClinicalTrials.govdeviceDevice trial
Verified
Study focus
Disease/Condition
Pulmonary Arterial Hypertension
Drug/Device/Intervention
Shape II CPET
Study type
Observational
Intervention type
device
Sponsor & location
Primary sponsor
Shape Medical Systems, Inc.
Location
Torrance,Denver,Jacksonville,Atlanta,Columbus,New York, United States of America
Timeline & enrollment
Phase
N/A
Start date
Aug 25, 2023
End date
Jul 30, 2025
Enrollment
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 hypertensionOther secondary pulmonary hypertensionPulmonary heart disease and diseases of pulmonary circulationStenosis of pulmonary arteryPulmonary heart disease, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05977933
Type
Device Trial
About this record

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.