Pulmonary Hypertension in Left Heart Disease

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT05935605
Status
Recruiting
Apply to this trial

Conditions

  • Left Heart Disease
  • Pulmonary Hypertension
  • Pulmonary Vascular Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Transthoracic Echocardiography (TTE) — DIAGNOSTIC_TEST
    Transthoracic echocardiography using ultrasound waves will be conducted during the rest and exercise phases of the clinically indicated invasive hemodynamic assessment by right heart catheterization to gather additional measurements of right ventricular function.
  • Lung ultrasound — DIAGNOSTIC_TEST
    A lung ultrasound, which uses sound waves to produce images of the lungs, will be used to assess extravascular lung fluid during the rest and exercise phases of the clinically indicated invasive hemodynamic assessment by right heart catheterization.

Study Details

The goal is to compare patients with and without varying severity of pulmonary vascular disease based upon hemodynamic signatures, echocardiographic measures, and lung ultrasound, in tandem with expired gas metabolic testing and blood sampling.

Key Dates

Start date
Jul 20, 2023
Status verified
Mar 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
3,000 participants (estimated)

Arms

  • Arm: LHD with no PH
    Subjects with Left Heart Disease (LHD) and no Pulmonary Hypertension (PH; mean pulmonary artery (PA) pressure ≤20 mmHg) that are already referred for invasive hemodynamic assessment by right heart catheterization for clinical reasons will undergo transthoracic echocardiography and lung ultrasound.
  • Arm: LHD with isolated PVH
    Subjects with Left Heart Disease (LHD) and isolated Pulmonary Venous Hypertension (PVH; mean PA pressure\>20 mmHg and PVR\<3 WU) that are already referred for invasive hemodynamic assessment by right heart catheterization for clinical reasons will undergo transthoracic echocardiography and lung ultrasound.
  • Arm: LHD with vasoactive PVD
    Subjects with Left Heart Disease (LHD) and vasoactive Pulmonary Vascular Disease (PVD; mean PA pressure\>20 mmHg and PVR≥3 WU with ≥20% reduction in PVR with inhaled nitric oxide) that are already referred for invasive hemodynamic assessment by right heart catheterization for clinical reasons will undergo transthoracic echocardiography and lung ultrasound.
  • Arm: LHD with fixed PVD
    Subjects with Left Heart Disease (LHD) and fixed Pulmonary Vascular Disease (PVD; mean PA pressure\>20 mmHg, PVR≥3 WU, and PVR reduction of \<20% with inhaled nitric oxide) that are already referred for invasive hemodynamic assessment by right heart catheterization for clinical reasons will undergo transthoracic echocardiography and lung ultrasound.

Primary Outcome Measure

Peak Exercise Cardiac Output [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Circulatory Failure Research Team
(507) 255-2200
Barry Borlaug, MD
[email protected]
(507) 255-4152
Barry Borlaug, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Mayo Clinic in Rochester· Rochester, MN

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