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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date July 2023
Source Medical University of South Carolina
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms

  • Heart Failure
  • Heart Failure With Normal Ejection Fraction
  • Heart Failure With Reduced Ejection Fraction

Locations

Country Name City State
United States Medical University of South Carolina Charleston South Carolina
United States Ralph H. Johnson VAMC Charleston South Carolina

Sponsors (1)

Lead Sponsor Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

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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