LYmphangiogenesis FacTors in Heart Failure States

Completed

• Conditions: Heart Failure With Reduced Ejection Fraction; Heart Failure With Normal Ejection Fraction; Heart Failure

• Registration Number: NCT03141567
• Lead Sponsor: Medical University of South Carolina

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-04-27
• Study First Submitted QC: 2017-05-02
• Study First Posted: 2017-05-05
• Study Start: 2017-05-18
• Primary Completion: 2021-02-03
• Study Completion: 2023-01-24
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-13
• Last Update Posted: 2023-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Undergoing clinically indicated right heart catheterization.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Lymphangiogenesis and 6 minute hall walk	At time of right heart catheterization	Correlation between lymphangiogenesis factors and 6 minute walk distance.
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
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.

Trial Locations

Locations (2)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Ralph H. Johnson VAMC; 🇺🇸 Charleston, South Carolina, United States