Effects of Pulmonary Hypertension Therapy in Atypical Pulmonary Arterial Hypertension

Effects of Pulmonary Hypertension Therapy in Atypical Pulmonary Arterial Hypertension: An Exercise Hemodynamic Study (TAPH Study)

The purpose of this study is to characterize the clinical and hemodynamic response of Pulmonary Arterial Hypertension (PAH) therapy in patients with atypical PAH and risk factors for left heart disease.

Study Overview

• Status: Completed
• Conditions: Pulmonary Arterial Hypertension

Detailed Description

This is an observational prospective study to better understand the clinical impact of Pulmonary Arterial Hypertension (PAH) specific therapy in patients with atypical PAH among those with risk factors for left heart disease

The study involves detailed baseline clinical evaluation prior to initiation of PAH therapy, followed by repeat clinical assessment after 6 months of medical therapy

• Study Type: Observational
• Enrollment (Actual): 19

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Eligible patients will be identified from screening of the pulmonary hypertension clinic who are then planned for outpatient catheterization for diagnosis and management of their atypical PAH.

Description

Inclusion Criteria:

• Age ≥ 18 years
• Pulmonary hypertension with mean PA pressure >20 mmHg and a planned initiation of pulmonary arterial hypertension therapy
• No active treatment for precapillary pulmonary hypertension
• Ambulatory (not wheelchair/scooter dependent)
• Presence of any risk factor for left heart disease will qualify for inclusion (either atrial fibrillation, body mass index>30 kg/m2, arterial hypertension, diabetes, coronary artery disease or age>60 years)

Exclusion Criteria:

• Significant chronic obstructive pulmonary disease that is a primary contributor to symptoms in the opinion of the investigator
• Ischemia thought to contribute to dyspnea in the opinion of the investigator
• Obstructive hypertrophic cardiomyopathy
• Known infiltrative cardiomyopathy (amyloid)
• Constrictive pericarditis or tamponade
• Active myocarditis
• Complex congenital heart disease
• More than mild aortic or mitral stenosis
• Intrinsic (prolapse, rheumatic) valve disease with more than moderate mitral, tricuspid or aortic regurgitation
• Acute or chronic severe liver disease as evidenced by any of the following: encephalopathy, variceal bleeding, INR > 1.7 in the absence of anticoagulation treatment
• Terminal illness (other than HF) with expected survival of less than 1 year
• Enrollment or planned enrollment in another therapeutic clinical trial in next 3 months.
• Inability to comply with planned study procedures
• Pregnancy or breastfeeding mothers

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Describe prevalence of occult left heart disease during exercise in atypical pulmonary hypertension, as defined by pulmonary arterial wedge pressure during exercise cardiac catheterization.	Pulmonary arterial wedge pressure >25 mmHg during exercise cardiac catheterization will indicate occult left heart disease.	Baseline Catheterization
Evaluate the therapeutic response of chronic pulmonary vasodilator therapy	Favorable pulmonary vasodilatory effect will be associated a change of > 10% reduction in pulmonary artery-pressure flow slope from baseline to 6 month catheterization	6 Month Catheterization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identify predictors on baseline exercise catheterization of subsequent exercise capacity improvement following chronic pulmonary vasodilatory therapy.	From paired exercise capacity measurements of peak VO2 from baseline to 6 month testing, patients with clinically meaningful change defined by improvement following treatment of >1 ml/kg/min will be identified. Measurements on baseline exercise catheterization, echocardiography, left atrial strain and clinical characteristics will be assessed for their ability to predict exercise capacity improvement by logistic regression.	6 Month Catheterization

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Yogesh N Reddy, MBBS, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2021
• Primary Completion (Actual): November 21, 2023
• Study Completion (Actual): November 21, 2023

Study Registration Dates

• First Submitted: February 15, 2021
• First Submitted That Met QC Criteria: March 5, 2021
• First Posted (Actual): March 8, 2021

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Right Heart Catheterization
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: 20-009542

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: No