LYmphangiogenesis FacTors in Heart Failure States

Heart Failure Clinical Trial

— LYFT-HF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03141567
• Other study ID #: Pro00062457
• Status: Completed
• 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
• 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

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