Assessing the Utility of Submaximal CPET in Treatment Management of PAH

March 12, 2024 updated by: Shape Medical Systems, Inc.

Assessing the Utility of Shape Submaximal Cardiopulmonary Exercise Testing in Detecting, Diagnosis and Treatment Management of Pulmonary Arterial Hypertension.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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 CPET) to standard echocardiographic evidence of PH (i.e 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
550

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Torrance, California, United States, 90502-2006
        • Harbor-UCLA Medical Center
        • Contact:
        • Principal Investigator:
          • Ronald Oudiz, MD
    • Colorado
      • Denver, Colorado, United States, 80206-2761
        • National Jewish Health
        • Contact:
        • Principal Investigator:
          • Marjorie P George, MD
    • Florida
      • Jacksonville, Florida, United States, 32224-1865
        • Mayo Clinic
        • Contact:
        • Principal Investigator:
          • Brian Taylor, Phd
    • Georgia
      • Atlanta, Georgia, United States, 30312-1213
        • Wellstar Health System
        • Contact:
        • Principal Investigator:
          • Paul Guichard, DO
      • Columbus, Georgia, United States, 31904-7955
    • New York
      • New York, New York, United States, 10021-9800
        • Weill Cornell Medicine
        • Principal Investigator:
          • Evelyn Horn, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The population will be consenting legal adults (minimum age 21 and no limit on maximum age) unless imposed by individual site standard of care (SoC). with no contraindications to exercise testing will be recruited. Suspected of pulmonary hypertension PH.

Description

Inclusion Criteria Study Aim 1:

  • Subject referred for clinical assessment due to unexplained or worsening dyspnea and/or suspected Pulmonary Hypertension (PH).
  • Subject is able and willing to provide appropriate Informed consent.
  • Subject is greater than or equal to 21 years old
  • Subject is not dependent on supplemental O2 to allow for CPET/sub-max-Shape exercise testing
  • Subject is capable of performing a sub-max, incremental step exercise protocol, both physically and mentally, with no absolute contraindications to exercise testing, such as those causing symptoms or hemodynamic compromise Contraindications include syncope, active endocarditis, myocarditis or pericarditis, symptomatic severe aortic stenosis, uncontrolled heart failure (HF), uncontrolled cardiac arrhythmia, acute pulmonary embolus or pulmonary infarction, thrombosis of lower extremities, suspected dissecting aneurysm, uncontrolled asthma, pulmonary edema, respiratory failure, acute non-pulmonary disorder that may affect exercise performance or be aggravated by exercise such as infarction, renal failure or thyrotoxicosis, medical impairment with inability to cooperate with protocol instructions

Inclusion Criteria Study Aim 2:

  • Subject must have been enrolled in Study Aim 1
  • Dyspnea subject who has undergone echo examination and presented with suspicion of pulmonary arterial hypertension (PAH) category world health organization (WHO) I (mean pulmonary artery pressure (PAP) ≥ 20 mmHg; pulmonary vascular resistance (PVR) > 2 WU and pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg

Exclusion Criteria Study Aim 1:

  • Resting Hypoxemia (oxygen saturation (Sp02) <85%)
  • The subject's mean arterial blood pressure is less than 70 mmHg despite fluid resuscitation and pressor therapy.
  • The subject has positive pregnancy test (verified in a manner consistent with institution's standard of care)
  • The subject has joint limitations to performing incremental exercise with gas exchange monitoring.

Exclusion Criteria Study Aim 2:

  • Normal pulmonary hemodynamics on right heart Catheterization (RHC) ( mean pulmonary arterial pressure (mPAP) ≤ 20mmHG)
  • RHC evidence of precapillary PH (mPAP >20 mmHg, PAWP ≤15 mmHg, PVR >2 WU) but has a diagnosis of group III, IV or V PH
  • RHC evidence isolated postcapillary PH (mPAP >20 mmHg, PAWP >15 mmHg, PVR ≤2 WU) or combined pre- and postcapillary PH (mPAP >20 mmHg, pulmonary arterial wedge pressure (PAWP) >15 mmHg, PVR >2 WU)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PAH Patients
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 PH can improve symptoms and functional capacity, and delayed diagnosis and treatment of PH likely reduces survival.
Device: Shape II CPET
Submaximal Cardiopulmonary exercise test equipment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Demonstrate the Submaximal Cardiopulmonary exercise testing (Shape CPET) is an effective complementary tool in the resting echocardiogram for detection of Pulmonary Hypertension.
Time Frame: 10-12 months

Identify Shape(CPET) gas exchange metrics, alone and in combination with echocardiographic (ECHO) measures to test for a correlation with Right heart catheterization (RHC) derived diagnostic determinations using standard uni- and multivariate analytic tools correlations with ECHO area under the curve (AUC) of receiver operating character (ROC) curves of Shape CPET+ ECHO vs those of Echo only screening will be used to examine if combining Shape with ECHO can improve the Echo only screening tool.

Identify variants of the fuzzy random forest walk algorithm. This approach, patients are divided into two groups: a training and test set. The algorithm creates "leaves" of unique variable combinations that "bag" all patients in the training set into categories of classification (pulmonary arterial hypertension). The combinatorial routine that best leads to the classification in the training set is applied to the testing set whose results are compared to the reference standard.
10-12 months
Demonstrate the percent change in submaximal Shape Cardiopulmonary exercise testing (Shape CPET) metrics and the 6 minute walk time distance (6MWTd)
Time Frame: 3 months and 6 months
Identify the percent changes in the Shape variables and 6-minute walk time distance (6MWTd) from baseline to first post treatment (90 days) and to second post treatment (180 days) will be averaged and compared statistically using two-way, paired "t" tests with a significance level set at p<.05.
3 months and 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The correlation of select non-invasive Shape Cardiopulmonary exercise test (CPET) metric to invasive hemodynamic variables
Time Frame: 10-12 months
Correlation of the Shape cardiopulmonary exercise test (CPET) variables with right heart catheterization (RHC) derived diagnostic determinations using standard uni- and multivariate analytic tools correlations with echocardiogram area under the curve (AUC) of receiver operating characteristics (ROC) curves of Shape CPET + Echocardiograph (Echo) vs those of Echo only screening will be used to examine if combining Shape with echocardiography can improve the Echo only screening tool
10-12 months
Assessment of Pharmacotherapy-induced improvement or sensitivity of changes in pulmonary hypertension severity and disease status
Time Frame: 3 months and 6 months
Identify changes from baseline to subsequent visits in values of Shape CPET variable in the physiological responses to a PAH functional class, 6MWTd and time to clinical worsening (TTCW). The TTCW or the "time to clinical worsening" is based upon 1) an increase in functional capacitance (FC); 2) a 15 % decrease in 6-minute walk test distance (6MWTd) 3) hospitalization in days 4) death in days.
3 months and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shape Medical Systems, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 7, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SHP0422
  • R44HL162169 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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