LYmphangiogenesis FacTors in Heart Failure States (LYFT-HF)

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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • Charleston, South Carolina, United States, 29401
      • Ralph H. Johnson VAMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Outpatient; Individuals undergoing clinically indicated Right Heart Catheterization.
Inpatient; Individuals undergoing clinically indicated Right Heart Catheterization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Lymphangiogenesis and 6 minute hall walk	Correlation between lymphangiogenesis factors and 6 minute walk distance.	At time of right heart catheterization

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Investigators: Principal Investigator: Brian Houston, M.D., Assistant Professor

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2017
• Primary Completion (Actual): February 3, 2021
• Study Completion (Actual): January 24, 2023

Study Registration Dates

• First Submitted: April 27, 2017
• First Submitted That Met QC Criteria: May 2, 2017
• First Posted (Actual): May 5, 2017

Study Record Updates

• Last Update Posted (Actual): July 14, 2023
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Heart Failure; Lymphangiogenesis
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: Pro00062457

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No