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Completed

NCT Number: NCT03141567

LYmphangiogenesis FacTors in Heart Failure States

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of South Carolina, Charleston, South Carolina, United States

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Vascular Endothelial Growth Factor (VEGF) Levels

    Time frame: 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 outcomes

  1. Lymphangiogenesis factors and Pulmonary Capillary Wedge Pressure (PCWP)

    Time frame: 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

    Time frame: 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

    Time frame: At time of right heart catheterization

    Correlation between lymphangiogenesis factors and 6 minute walk distance.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

LYmphangiogenesis FacTors in Heart Failure States (LYFT-HF Study)

Acronym: LYFT-HF

Important dates

Study start
2017
Primary completion
2021
Study completion
2023
First posted
May 5, 2017
Registry last updated
Jul 14, 2023

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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