Clinical trial NCT04964817: HFpEF and Symptomatic Obstructive Iliofemoral Venous Disease Study
Official title: Heart Failure With Preserved Ejection Fraction (HFpEF) and Symptomatic Obstructive Iliofemoral Venous Disease and Venous Stenting: A Pilot Cohort Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Heart Failure With Preserved Ejection Fraction
Venous Disease
Lead sponsor: Prairie Education and Research Cooperative
Sponsor class: INDUSTRY
Collaborators: name: Boston Scientific Corporation
name: Medtronic
name: Philips Healthcare
First posted: 2021-07-16
Enrollment: 3
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male and female patients ≥40 years old with diagnosed HFpEF by established standard of care clinical ACC/AHA Congestive Heart Failure Definition and Clinical Guidelines23 and a Mayo Clinic H2FpEF Score ≥ 4 with evidence of peripheral venous disease assessed by the CEAP Classification 3 according to the Reporting Standards of International Society of Cardiovascular Surgery (ISCV)/Society of Vascular Society (SVS).24

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Willing and able to provide informed consent and comply with all study requirements
* Age ≥ 40 years of age
* Stable, symptomatic heart failure with preserved ejection fraction and a H2FpEF Score ≥4
* Presence of non-malignant inferior vena cava obstruction, a unilateral or bilateral chronic non-malignant obstruction of the common femoral vein, external iliac vein, common iliac vein, or any combination thereof, defined as a ≥50% reduction in target vessel lumen diameter defined by screening MRV, CTV and confirmed by a 50% reduction in luminal area as assessed by intraprocedural IVUS.
* Previous (\>6 months) history of ilio-femoral and/or lower extremity deep venous thrombosis associated with a residual ilio-femoral venous obstruction ≥50% by MRV, CTV.
* Clinically significant venous obstruction meeting CEAP Clinical classification ≥3.
* Negative pregnancy test in females of child-bearing potential

Exclusion Criteria:

* Subject hospitalized for acute compensated heart failure within 60 days prior to enrollment
* Presence of history of clinically significant pulmonary emboli within 6 months prior to enrollment.
* Subject has any permanent neurologic defect that may cause non-compliance with the protocol
* Subject has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematous).
* Subject has an allergy to contrast media that cannot be adequately pre-treated prior to the required diagnostic and/or endovascular procedures.
* Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding.
* Subject has renal failure or chronic kidney disease with glomerular filtration rate (GFR) ≤ 30 mL/min or Modification of Diet in Renal Disease (MDRD) study equation result of ≤ 30 mL/min per 1.73 m2.
* Subject has white blood cell (WBC) count \< 3.0 (3000 cells/mm3) within 7 days prior to index procedure.
* Subject has a platelet count \< 80,000 cells/mm3 or \> 700,000 cells/mm3 ≤ 7 days pre procedure; uncorrected hemoglobin of ≤9 g/dL.
* Subject has known or suspected active systemic infection evidenced by WBC \> 14.0 (14,000/mm3).
* Subject is currently participating in another investigational drug or device study.
* Subject intends to participate in another investigational drug or device study within 30 days after the index procedure.
* Subject has moderate or severe pulmonary disease (i.e., COPD) considered by Investigator to be a major contributing factor to the subject's exertional dyspnea

Primary outcomes:
measure: Evaluate potential change in metrics of functional capacity assessed by Cardiopulmonary Exercise Testing performed before and after venous stenting
timeFrame: 180 days
Secondary outcomes:
measure: Identify patient functional change utilizing the FDA-approved Minnesota Living with Heart Failure Questionnaire as a Medical Device Development Tool (MDDT) post treatment versus pre treatment
timeFrame: 180 days
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Prairie Heart Institute at St. Johns Hospital
state: Illinois
Study officials:
affiliation: Prairie Cardiovascular Consultants
name: Krishna Rocha-Singh, MD
role: PRINCIPAL_INVESTIGATOR
References: