Heart Failure With Preserved Ejection FractionPERSUADENCT04964817
HFpEF and Symptomatic Obstructive Iliofemoral Venous Disease Study
An observational study of Heart Failure With Preserved Ejection Fraction and Venous Disease, run by Prairie Education and Research Cooperative at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction, Venous Disease
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2021to 12 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Prairie Heart Institute at St. Johns Hospital
Springfield, Illinois, 62769
About this study
Official title: Heart Failure With Preserved Ejection Fraction (HFpEF) and Symptomatic Obstructive Iliofemoral Venous Disease and Venous Stenting: A Pilot Cohort Study
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.
Read the 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate potential change in metrics of functional capacity assessed by Cardiopulmonary Exercise Testing performed before and after venous stenting
The primary focus of the study is to estimate the change in functional capacity in patients of heart failure with preserved ejection fraction (HFpEF) of varying severities and chronic peripheral venous disease associated with pelvic venous obstruction after resolution via IVUS-guided venous stenting. Key estimate will be the change in functional capacity (i.e., VO2max or 6MWD) as assessed by the percentage change in pre- and post-venous stenting. No formal hypothesis tests are pre-specified.
Measured: 180 days
Secondary outcomes (1)
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
The secondary outcome measure of the study is to estimate the change in functional capacity in patients of heart failure with preserved ejection fraction (HFpEF) of varying severities and chronic peripheral venous disease associated with pelvic venous obstruction after resolution via IVUS-guided venous stenting. Key estimate will be the change in functional capacity as assessed by the percentage change in pre- and post-venous stenting utilizing the Minnesota Living with Heart Failure Questionnaire (MLHFQ). No formal hypothesis tests are pre-specified.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start3 Aug 2021
- Primary completion12 Apr 2023
- Study completion12 Apr 2023
Why it stopped: unable to recruit following changes to practice resulting from pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prairie Education and Research Cooperative
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Boston Scientific Corporation, Medtronic, Philips Healthcare
- Responsible party
- Sponsor
- Investigators
- Krishna Rocha-Singh, MD, Principal investigator, Prairie Cardiovascular Consultants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04964817
- Sponsor's protocol ID
- 1309580
- Acronym
- PERSUADE
- Status last verified
- Apr 2023
- First submitted
- 18 Jun 2021
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Failure With Preserved Ejection Fraction (HFpEF) and Symptomatic Obstructive Iliofemoral Venous Disease and Venous Stenting: A Pilot Cohort Study
- ClinicalTrials.gov ID
- NCT04964817
- Acronym / sponsor ID
- PERSUADE / 1309580
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: unable to recruit following changes to practice resulting from pandemic
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Prairie Education and Research CooperativeIndustry (pharma, biotech, devices)
- Collaborators
- Boston Scientific Corporation, Medtronic, Philips Healthcare
- Study start
- 3 Aug 2021 (actual)
- Primary completion
- 12 Apr 2023 (actual)
- Study completion
- 12 Apr 2023 (actual)
- First posted
- 16 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate potential change in metrics of functional capacity assessed by Cardiopulmonary Exercise Testing performed before and after venous stenting
Time frame: 180 days
The primary focus of the study is to estimate the change in functional capacity in patients of heart failure with preserved ejection fraction (HFpEF) of varying severities and chronic peripheral venous disease associated with pelvic venous obstruction after resolution via IVUS-guided venous stenting. Key estimate will be the change in functional capacity (i.e., VO2max or 6MWD) as assessed by the percentage change in pre- and post-venous stenting. No formal hypothesis tests are pre-specified.
1 secondary outcome
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
Time frame: 180 days
Results and safety
The study was stopped early (reason given: unable to recruit following changes to practice resulting from pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Krishna Rocha-Singh, MD principal investigator
Prairie Cardiovascular Consultants
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure With Preserved Ejection Fraction and Venous Disease, run by Prairie Education and Research Cooperative at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: unable to recruit following changes to practice resulting from pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate potential change in metrics of functional capacity assessed by Cardiopulmonary Exercise Testing performed before and after venous stenting (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.