Ignite Creation Date:
2024-05-06 @ 7:19 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05977933
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-13
First Post:
2023-06-29
Brief Title:
Assessing the Utility of Submaximal CPET in Treatment Management of PAH
Sponsor:
Shape Medical Systems Inc
Organization:
Shape Medical Systems Inc
Study Overview
Official Title:
Assessing the Utility of Shape Submaximal Cardiopulmonary Exercise Testing in Detecting Diagnosis and Treatment Management of Pulmonary Arterial Hypertension
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Pulmonary hypertension PH is a devastating disease characterized by progressive dyspneaexercise intolerance right-heart failure and carries a high risk of morbidity and early mortality PH disease progression can be rapid and any delay in the diagnosis and treatment of PH likely reduces survival Given its clinical and prognostic significance early and accurate diagnosis of PH to allow prompt and optimal establishment of clinical care is of critical importance While traditional maximalcomprehensive cardiopulmonary exercise testing CPET has been validated in PH it has limitations that have hindered its applicability to routine clinical assessment and monitoring Our preliminary data suggest that the signature ventilatory and pulmonary gas exchange derangements of PH become apparent during even submaximal exercise Our comprehensive proof-of-concept study 133 patients supports our hypothesis that the addition of pulmonary gas exchange responses to a standardized 3-minute submaximal exercise test Shape CPET to standard echocardiographic evidence of PH ie Right ventricular systolic pressure RVSP 50 mmHg suspicion of Right ventricular RV dysfunction improves the sensitivity for PH detection by almost 40 The Shape CPET system is compact and utilizes pattern-recognition software that automates interpretation making the system ideally suitable for widespread adoption The overarching objective of this small business innovation research SBIR proposal is to categorically establish the Shape CPET as a tool that 1 improves early detection of PH and 2 provides an objective evidence-based measure of PH therapy efficacy that can be easily used in academic and community practices Investigators have established a 10-center consortium of academic and community PH centers for this SBIR proposal Specific Aim 1 will assess the clinical utility of submaximal cardiopulmonary exercise testing as a complementary tool for the identification of pulmonary hypertension Specific Aim 2 will assess whether pharmacotherapy-induced improvements in pulmonary hypertension severity and disease status are reflected in the physiological responses to a standardized submaximal cardiopulmonary exercise test The investigators hypothesize that the Shape CPET will prove to be an efficacious adjunct to traditional clinical metrics to track changes in pulmonary vascular function over time and responses to therapy aimed at alleviating PAH
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R44HL162169 | NIH | None | httpsreporternihgovquickSearchR44HL162169 |