Effects of Pulmonary Hypertension Therapy in Atypical Pulmonary Arterial Hypertension

NCT04787445 | Completed

• 1 other identifier: 20-009542
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Arterial Hypertension

Keywords

Right Heart Catheterization

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Identify predictors on baseline exercise catheterization of subsequent exercise capacity improvement following chronic pulmonary vasodilatory therapy.

  6 Month Catheterization

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

Samples with and without DNA will both be retained.

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yogesh N Reddy, MBBS

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: March 8, 2021
• Study Start: March 11, 2021
• Primary Completion: November 21, 2023
• Study Completion: November 21, 2023
• Last Updated: March 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)