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NCT Number: NCT07483203

A Study Of Clinical Implications Of Pulmonary Vascular Disease In Valvular Heart Disease

The purpose of this study is to characterize pulmonary hemodynamic profiles, with a focus on PVR subtypes, in patients with left-sided valvular heart disease undergoing aortic or mitral valve intervention, and to identify patterns predicting reversibility of TR and RV dysfunction.

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Key information

Conditions

Pulmonary Vascular Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Valvular Heart Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Barry Borlaug, MD

CONTACT

[email protected]

(507) 255-1051

Barry Borlaug, MD

PRINCIPAL_INVESTIGATOR

Dr. Borlaug's Research Team

CONTACT

(507) 255-2200

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥18 years old; AND
  • Scheduled for valve procedures

Exclusion criteria

  • Congenital heart disease (except for bicuspid aortic valve), OR
  • Carcinoid heart disease, OR
  • Valvular mass, OR
  • Endocarditis, OR
  • Any other condition that, in the opinion of the investigator, would impair their ability to complete the study

Treatment and study plan

Echocardiogram

Diagnostic Test

An echocardiogram will be performed during the patient's routinely scheduled right heart catheterization.

Primary outcomes

  1. Tricuspid Regurgitation (TR) reduction

    Time frame: Baseline, 12 months

    Tricuspid Regurgitation (TR) reduction will be defined as ≥1 grade reduction

  2. Right Ventricular function improvement

    Time frame: Baseline, 12 months

    Right Ventricular function improvement will be defined as ≥5% in Right Ventricular free wall longitudinal strain

Secondary outcomes

  1. Number of Hospitalizations

    Time frame: 12 months

    Number of Hospitalizations will be determined by the number of patients admitted to the hospital post procedure

  2. Number of Deaths

    Time frame: 12 months

    Number of Death will be determined by the number of patients that pass away post procedure due to any cause

  3. Kansas City Cardiomyopathy Questionnaire (KCCQ)

    Time frame: Baseline, 6 months, and 12 months

    KCCQ is a 12-item questionnaires that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. Scores were generated for each domain and scaled from 0 to 70, with 0 (worst) and 70 (the best possible status), where the higher score reflected better health status.

  4. Right atrial area change

    Time frame: Baseline

    Right atrial area change is used to assess right vascular function. It will measure the area of change within the right ventricle between diastole and systole as a percentage.

  5. Tricuspid annular plane systolic excursion (TAPSE)

    Time frame: Baseline

    Tricuspid annular plane systolic excursion will be used to measure right ventricular function and measured in mm (millimeters)

Study contacts

Contact information is provided by the study sponsor or research team.

Annabelle Fuenffinger

CONTACT

[email protected]

507-422-3801

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Clinical Implications of Pulmonary Vascular Disease in Valvular Heart Disease

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 19, 2026
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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