Assessing the Utility of Submaximal CPET in Treatment Management of PAH

NCT05977933 | Not Yet Recruiting DMC FDA Device

• 2 other identifiers: SHP0422R44HL162169
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 6

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.

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (2)

• Demonstrate the Submaximal Cardiopulmonary exercise testing (Shape CPET) is an effective complementary tool in the resting echocardiogram for detection of Pulmonary Hypertension.

  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)

  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 Outcomes (2)

• The correlation of select non-invasive Shape Cardiopulmonary exercise test (CPET) metric to invasive hemodynamic variables

  10-12 months

• Assessment of Pharmacotherapy-induced improvement or sensitivity of changes in pulmonary hypertension severity and disease status

  3 months and 6 months

Study Arms (1)

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

Interventions

Shape II CPET DEVICE

Submaximal Cardiopulmonary exercise test equipment

PAH Patients

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• Shape Medical Systems, Inc.: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (6)

Harbor-UCLA Medical Center

Torrance, California, 90502-2006, United States

Location

National Jewish Health

Denver, Colorado, 80206-2761, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224-1865, United States

Location

WellStar Health System

Atlanta, Georgia, 30312-1213, United States

Location

Southeastern Cardiology

Columbus, Georgia, 31904-7955, United States

Location

Weill Cornell Medicine

New York, New York, 10021-9800, United States

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: August 7, 2023
• Study Start: April 1, 2024
• Primary Completion: September 30, 2024
• Study Completion: December 30, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)