# Assessing the Utility of Submaximal Cardiopulmonary Exercise Testing in Diagnosis and Treatment Management of Pulmonary Arterial Hypertension

> **NIH NIH R44** · SHAPE MEDICAL SYSTEMS, INC. · 2022 · $1,223,664

## Abstract

Abstract
Pulmonary hypertension (PH) is a devastating disease characterized by progressive dyspnea/exercise
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 maximal/comprehensive 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 iCPET) to standard echocardiographic
evidence of PH (i.e. RVSP >50 mmHg, suspicion of RV dysfunction) improves the sensitivity for PH detection
by almost 40%. The Shape iCPET system is compact and utilizes pattern-recognition software that automates
interpretation, making the system ideally suitable for widespread adoption. The overarching objective of this
SBIR proposal is to categorically establish the Shape iCPET 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. We 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. We hypothesize that the Shape
iCPET 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.

## Key facts

- **NIH application ID:** 10482044
- **Project number:** 1R44HL162169-01A1
- **Recipient organization:** SHAPE MEDICAL SYSTEMS, INC.
- **Principal Investigator:** Dean Judson MacCarter
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $1,223,664
- **Award type:** 1
- **Project period:** 2022-09-01 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10482044

## Citation

> US National Institutes of Health, RePORTER application 10482044, Assessing the Utility of Submaximal Cardiopulmonary Exercise Testing in Diagnosis and Treatment Management of Pulmonary Arterial Hypertension (1R44HL162169-01A1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10482044. Licensed CC0.

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