Heart Failure Clinical Trial
— LYFT-HFOfficial title:
LYmphangiogenesis FacTors in Heart Failure States (LYFT-HF Study)
NCT number | NCT03141567 |
Other study ID # | Pro00062457 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 18, 2017 |
Est. completion date | January 24, 2023 |
Verified date | July 2023 |
Source | Medical University of South Carolina |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | January 24, 2023 |
Est. primary completion date | February 3, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Ralph H. Johnson VAMC | Charleston | South Carolina |
Lead Sponsor | Collaborator |
---|---|
Medical University of South Carolina |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Vascular Endothelial Growth Factor (VEGF) Levels | VEGF levels in systemic venous, pulmonary arterial, and pulmonary venous samples in participants with left heart failure versus those without left heart failure. | At time of right heart catheterization | |
Secondary | Lymphangiogenesis factors and Pulmonary Capillary Wedge Pressure (PCWP) | Correlation between above lymphangiogenesis factors and pulmonary capillary wedge pressure, right atrial pressure, and cardiac output gathered from right heart catheterization. | At time of right heart catheterization | |
Secondary | Lymphangiogenesis and Heart failure severity | Correlation between lymphangiogenesis factors and heart failure symptom severity as determined by the Kansas City Cardiomyopathy Questionnaire | At time of right heart catheterization | |
Secondary | Lymphangiogenesis and 6 minute hall walk | Correlation between lymphangiogenesis factors and 6 minute walk distance. | At time of right heart catheterization |
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