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CompletedNCT04787445Updated Mar 21, 2024

Effects of Pulmonary Hypertension Therapy in Atypical Pulmonary Arterial Hypertension

An observational study in Pulmonary Arterial Hypertension, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-21.

Sponsored by Mayo Clinic · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
19
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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

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Conditions studied

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In context

Hypertension, Pulmonary

1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.

This study's enrollment of 19 is below the median of 116 across 386 observational studies indexed under Hypertension, Pulmonary.

Browse Hypertension, Pulmonary studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
19 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna
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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline Catheterization

  2. 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

    Time frame: 6 Month Catheterization

Other outcomes

  1. 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.

    Time frame: 6 Month Catheterization

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Study locations

1 site
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
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References and documents

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04787445
Lead sponsor
Mayo Clinic
Responsible party
Yogesh Reddy (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Mar 8, 2021
Start date
Mar 11, 2021
Primary completion
Nov 21, 2023
Completion
Nov 21, 2023
Last update
Mar 21, 2024

Study contacts

Yogesh N Reddy, MBBS
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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