LYmphangiogenesis FacTors in Heart Failure States

NCT03141567 | Completed

• 1 other identifier: Pro00062457
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Heart Failure; Heart Failure With Reduced Ejection Fraction; Heart Failure With Normal Ejection Fraction

Keywords

Lymphangiogenesis; Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Lymphangiogenesis factors and Pulmonary Capillary Wedge Pressure (PCWP)

  At time of right heart catheterization

• Lymphangiogenesis and Heart failure severity

  At time of right heart catheterization

• Lymphangiogenesis and 6 minute hall walk

  At time of right heart catheterization

Study Arms (2)

Outpatient

Individuals undergoing clinically indicated Right Heart Catheterization.

Inpatient

Individuals undergoing clinically indicated Right Heart Catheterization.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All Inpatient and Outpatient individuals undergoing clincially-indicated right heart catheterization.

You may qualify if:

• Undergoing clinically indicated right heart catheterization.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (2)

Ralph H. Johnson VAMC

Charleston, South Carolina, 29401, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

plasma or serum

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Brian Houston, M.D.

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2017
• First Posted: May 5, 2017
• Study Start: May 18, 2017
• Primary Completion: February 3, 2021
• Study Completion: January 24, 2023
• Last Updated: July 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)