HFpEF and Symptomatic Obstructive Iliofemoral Venous Disease Study — PERSUADE  

Heart Failure With Preserved Ejection Fraction Clinical Trial

Official title: Heart Failure With Preserved Ejection Fraction (HFpEF) and Symptomatic Obstructive Iliofemoral Venous Disease and Venous Stenting: A Pilot Cohort Study

Status Terminated

Clinical Trial Summary

To ascertain the potential symptom improvement assessed by Cardiopulmonary Exercise Testing (CPET) in subjects with heart failure with preserved ejection fraction (HFpEF) and nonthrombotic iliofemoral venous lesions and/or iliocaval obstruction defined by MR or CT venography AND CEAP Clinical Category ≥3 prior to venous stenting.

Clinical Trial Description

Primary Objective:

Evaluate potential improvement in metrics of functional capacity assessed by Cardiopulmonary Exercise Testing performed before and after venous stenting of an ≥50% iliofemoral venous obstruction by MR or CT venography and confirmed by intra-procedural IVUS in a prospective patient cohort presenting with heart failure with preserved ejection fraction with a H2FpEF score of ≥4 AND a CEAP Category ≥3.

Secondary Objectives:

Identify patient demographic, baseline laboratory, imaging, procedural and Cardiopulmonary Exercise Testing variables and the FDA-approved Minnesota Living with Heart Failure Questionnaire as a Medical Device Development Tool (MDDT) in patients with and without functional improvement as assessed by Cardiopulmonary Exercise Testing VO2max after successful venous stenting of iliofemoral/iliocaval venous obstructions. ;

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Preserved Ejection Fraction
• Venous Disease

• NCT number: NCT04964817
• Study type: Observational
• Source: Prairie Education and Research Cooperative
• Status: Terminated
• Start date: August 3, 2021
• Completion date: April 12, 2023