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LYFT-HF: LYmphangiogenesis FacTors in Heart Failure States

Sponsor
Medical University of South Carolina (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03141567
Collaborator
(none)
100
Enrollment
2
Locations
68.5
Anticipated Duration (Months)
50
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Heart failure often causes fluid to accumulate in the body, leading to congestion and swelling. However, some people who have had heart failure for a long time seem to have very little congestion or swelling, even when the heart failure is poorly treated. The investigators think that this is because lymphatic vessels are able to grow and remove fluid to prevent congestion. The investigators do not know how lymphatic vessels grow. This study will investigate the blood levels of various proteins to try to figure out how the lymph vessels of people with long-standing heart failure might grow.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    100 participants
    Observational Model:
    Other
    Time Perspective:
    Other
    Official Title:
    LYmphangiogenesis FacTors in Heart Failure States (LYFT-HF Study)
    Actual Study Start Date :
    May 18, 2017
    Actual Primary Completion Date :
    Feb 3, 2021
    Anticipated Study Completion Date :
    Feb 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Outpatient

    Individuals undergoing clinically indicated Right Heart Catheterization.
    Inpatient

    Individuals undergoing clinically indicated Right Heart Catheterization.

    Outcome Measures

    Primary Outcome Measures

    1. Vascular Endothelial Growth Factor (VEGF) Levels [At time of right heart catheterization]

      VEGF levels in systemic venous, pulmonary arterial, and pulmonary venous samples in participants with left heart failure versus those without left heart failure.

    Secondary Outcome Measures

    1. Lymphangiogenesis factors and Pulmonary Capillary Wedge Pressure (PCWP) [At time of right heart catheterization]

      Correlation between above lymphangiogenesis factors and pulmonary capillary wedge pressure, right atrial pressure, and cardiac output gathered from right heart catheterization.

    2. Lymphangiogenesis and Heart failure severity [At time of right heart catheterization]

      Correlation between lymphangiogenesis factors and heart failure symptom severity as determined by the Kansas City Cardiomyopathy Questionnaire

    3. Lymphangiogenesis and 6 minute hall walk [At time of right heart catheterization]

      Correlation between lymphangiogenesis factors and 6 minute walk distance.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Undergoing clinically indicated right heart catheterization.
    Exclusion Criteria:

    • Unable to provide consent.

    • Use of medications which may alter lymphangiogenesis factor expression within 365 days

    • Thalidomide, lenalidomide, pomalidomide

    • Bevacizumab

    • Any cytotoxic chemotherapy agents

    • Pregnant

    • Any potentially pregnant patient (based on age and gender) undergoes Beta Human chorionic gonadotropin testing as standard of care prior to any right heart catheterization.

    • Active cancer within 365 days

    • Diagnosis of familial or secondary lymphedema

    • Treatment of active bacterial infection within 7 days

    • Active inflammatory rheumatologic disease requiring anti-inflammatory therapy administration within 60 days

    • Conditions

    • Systemic lupus erythematosus

    • Rheumatoid arthritis

    • Scleroderma

    • Inflammatory myositis

    • Vasculitis

    • Behcet's disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ralph H. Johnson VAMC Charleston South Carolina United States 29401
    2 Medical University of South Carolina Charleston South Carolina United States 29425

    Sponsors and Collaborators

    • Medical University of South Carolina

    Investigators

    • Principal Investigator: Brian Houston, M.D., Assistant Professor

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Medical University of South Carolina
    ClinicalTrials.gov Identifier:
    NCT03141567
    Other Study ID Numbers:
    • Pro00062457
    First Posted:
    May 5, 2017
    Last Update Posted:
    Jun 30, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Medical University of South Carolina
    Lymphangiogenesis
    Heart Failure
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Jun 30, 2022