RECRUITING

RESPONDER-HF Trial

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Conditions

Heart FailureHeart Failure, DiastolicHeart failure with preserved ejection fraction (HFpEF)Heart failure with midrange ejection fraction (HFmrEF)Interatrial Shunt

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Multicenter, Prospective, Randomized, Sham Controlled, Double Blinded Clinical Trial, with; 1:1 randomization

Official Title

Re-Evaluation of the Corvia Atrial Shunt Device in a Precision Medicine Trial to Determine Efficacy in Mildly Reduced or Preserved Ejection Fraction (EF) Heart Failure (Protocol #2201)

Quick Facts

Study Start:2022-11-17
Study Completion:2031-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05425459

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Chronic symptomatic heart failure (HF) documented by the following:
  2. 1. Symptoms of HF requiring current treatment with diuretics if tolerated for ≥ 30 days AND
  3. 2. New York Heart Association (NYHA) class II; OR NYHA class III, or ambulatory NYHA class IV symptoms; AND
  4. 3. ≥ 1 HF hospital admission (with HF as the primary, or secondary diagnosis); or treatment with intravenous (IV) diuretics; or intensification of oral diuresis within the 12 months prior to study entry; OR an NT-proB-type Natriuretic Peptide (NT-pro BNP) value \> 150 pg/ml in normal sinus rhythm, \> 450 pg/ml in atrial fibrillation, or a brain natriuretic peptide (BNP) value \> 50 pg/ml in normal sinus rhythm, \> 150 pg/ml in atrial fibrillation within the past 6 months
  5. 2. Ongoing stable guideline-directed medical therapy (GDMT) HF management and management of comorbidities according to the 2022 American College of Cardiology (ACC)/American Heart Association (AHA) Guidelines for the Management of Heart Failure. Stable management includes a minimum period of 4 weeks post-hospitalization for any cause, including treatment with IV diuretics
  6. 3. Site determined echocardiographic LV ejection fraction ≥ 40% within the past 6 months, without documented ejection fraction \< 30% in the 5 years prior.
  7. 4. Site determined echocardiographic evidence of diastolic dysfunction documented by one or more of the following:
  8. 1. Left Atrial (LA) diameter \> 4 cm; or
  9. 2. Diastolic LA volume \> 50 or LA volume index \> 28 ml/m2 or
  10. 3. Lateral e' \< 10 cm/s; or
  11. 4. e' \< 8 cm/s; or
  12. 5. Site determined elevated pulmonary capillary wedge pressure (PCWP) with a gradient compared to right atrial pressure (RAP) documented by end-expiratory PCWP during supine ergometer exercise ≥ 25 millimeters of mercury (mm Hg), and greater than RAP by ≥ 5 mm Hg.
  13. 6. Resting RAP ≤ 14 mmHg
  14. 7. Site determined hemodynamic evidence of peak exercise pulmonary vascular resistance (PVR) \< 1.75 Wood units
  15. 8. Age ≥ 40 years old
  16. 9. Participant has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the Institutional Review Board (IRB) or Ethics Committee (EC)
  17. 10. Participant is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams
  18. 11. Transseptal catheterization and femoral vein access to the right atrium is determined to be feasible by site interventional cardiology investigator.
  1. 1. Advanced heart failure defined as one or more of the below:
  2. 1. ACC/AHA/European Society of Cardiology (ESC) Stage D heart failure, non-ambulatory NYHA Class IV HF
  3. 2. Cardiac index \< 2.0 L/min/m2
  4. 3. Inotropic infusion (continuous or intermittent) for EF \< 40% within the past 6 months
  5. 4. Patient is on the cardiac transplant waiting list.
  6. 2. Inability to perform 6-minute walk test (distance \< 50 meters), OR 6-minute walk test \> 600m
  7. 3. The patient has verified that the ability to walk 6 minutes is limited primarily by joint, foot, leg, hip or back pain; unsteadiness or dizziness or lifestyle (and not by shortness of breath and/or fatigue and/or chest pain)
  8. 4. Right ventricular dysfunction, assessed by the site cardiologist and defined as one or more of the following:
  9. 1. More than mild right ventricular (RV) dysfunction as estimated by transthoracic echocardiogram (TTE); OR
  10. 2. TAPSE \< 1.4 cm; OR
  11. 3. Right ventricular (RV) size ≥ left ventricular (LV) size as estimated by TTE; OR
  12. 4. Ultrasound or clinical evidence of congestive hepatopathy; OR
  13. 5. Evidence of RV dysfunction defined by TTE as an RV fractional area change \< 35%.
  14. 5. Any implanted cardiac rhythm device
  15. 6. Structural heart repair aortic valve replacement (AVR) or mitral valve replacement (MVR) (surgical or percutaneous) within the past 12 months; planned valve intervention in the next 3 months, or presence of hemodynamically significant valve disease as assessed by the site cardiologist and defined as:
  16. 1. Mitral valve disease grade ≥ 3+ mitral regurgitation (MR) or \> mild Mitral Stenosis (MS); OR
  17. 2. Tricuspid valve (TR) regurgitation grade ≥ 2+ TR; OR
  18. 3. Aortic valve disease ≥ 2+ aortic regurgitation (AR) or \> moderate aortic stenosis (AS)
  19. 7. Echocardiographic evidence of intra-cardiac mass, thrombus or vegetation
  20. 8. Participants with existing or surgically closed (with a patch) atrial septal defects. Participants with a patent foramen ovale (PFO), who meet PCWP criteria despite the PFO, are not excluded
  21. 9. Myocardial Infarction (MI) and/or percutaneous cardiac intervention within past 3 months; Coronary Artery Bypass Graft (CABG) surgery in past 3 months or any planned cardiac interventions in the 3 months following enrollment.
  22. 10. Known clinically significant un-revascularized coronary artery disease, defined as: coronary artery stenosis with angina or other evidence of ongoing active coronary ischemia
  23. 11. Known clinically significant untreated carotid artery stenosis likely to require intervention
  24. 12. Atrial fibrillation with resting heart rate (HR) \> 100 beats-per-minute (BPM)
  25. 13. Hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis or infiltrative cardiomyopathy (e.g. hemochromatosis, sarcoidosis)
  26. 14. History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 6 months
  27. 15. Participant is contraindicated to receive either dual antiplatelet therapy, or an oral anticoagulant; or has a documented coagulopathy
  28. 16. Anemia with Hemoglobin \< 10 g/dl
  29. 17. Chronic pulmonary disease requiring continuous home oxygen, OR significant chronic pulmonary disease defined as forced expiratory volume (FEV)1 \<1Liter
  30. 18. Resting arterial oxygen saturation \< 95% on room air, \<93% when residing at high altitude
  31. 19. Currently requiring dialysis; or estimated glomerular filtration rate eGFR \< 25ml/min/1.73 m2 by chronic kidney disease (CKD) CKD-Epi equation
  32. 20. Systolic blood pressure \> 170 mm Hg at screening
  33. 21. Significant hepatic impairment defined as 3 times upper limit of normal of transaminases, total bilirubin, or alkaline phosphatase
  34. 22. Participants on significant immunosuppressive treatment or on systemic steroid treatment
  35. 23. Life expectancy less than 12 months for known non-cardiovascular reasons
  36. 24. Known hypersensitivity to nickel or titanium
  37. 25. Women of childbearing potential
  38. 26. Severe obstructive sleep apnea not treated with continuous positive airway pressure (CPAP) or other measures
  39. 27. Body Mass Index (BMI) \> 45; BMI 40 - 45 is also excluded unless in the opinion of the investigator, vascular access can be obtained safely
  40. 28. Severe depression and/or anxiety
  41. 29. Currently participating in an investigational drug or device study that would interfere with the conduct or results of this study. Note: trials requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational
  42. 30. In the opinion of the investigator, the Participant is not an appropriate candidate for the study.

Contacts and Locations

Study Contact

Jan Komtebedde, DVM
CONTACT
978-654-6113
jkomtebedde@corviamedical.com
Karen Stephen, RN, BS
CONTACT
618-604-2814
kstephens@corviamedical.com

Principal Investigator

Sanjiv Shah, MD
PRINCIPAL_INVESTIGATOR
Northwestern Memorial Hospital
Martin Leon, MD
PRINCIPAL_INVESTIGATOR
Columbia University

Study Locations (Sites)

Arizona Cardiovascular Research Center
Phoenix, Arizona, 85016
United States
Scripps Clinic
La Jolla, California, 92037
United States
MemorialCare Long Beach Medical Center
Long Beach, California, 90806
United States
Christiana Care Health Services
Newark, Delaware, 19718
United States
Memorial Regional Hospital
Hollywood, Florida, 33021
United States
NCH Naples
Naples, Florida, 34102
United States
Sarasota Memorial Hospital (Intercoastal Medical Group)
Sarasota, Florida, 34239
United States
Cleveland Clinic Florida
Weston, Florida, 33331
United States
Northside Hospital Gwinnett Campus
Lawrenceville, Georgia, 30046
United States
Wellstar Kennestone
Marietta, Georgia, 30060
United States
Northwestern University
Chicago, Illinois, 60611
United States
University of Chicago Medical Center
Chicago, Illinois, 60637
United States
Cardiovascular Institute of the South (CIS)
Houma, Louisiana, 70360
United States
LSU Health Shreveport
Shreveport, Louisiana, 71103
United States
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01805
United States
UMass Memorial Hospital University Campus
Worcester, Massachusetts, 01655
United States
University of Michigan Health Systems
Ann Arbor, Michigan, 48109
United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905
United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
United States
University of Cincinatti Medical Center
Hackensack, New Jersey, 07601
United States
Weill Cornell
New York, New York, 10065
United States
Christ Hospital
Cincinnati, Ohio, 45219
United States
University of Cincinatti Medical Center
Cincinnati, Ohio, 45219
United States
Cleveland Clinic OH
Cleveland, Ohio, 44195
United States
Ohio State University Wexner medical Center
Columbus, Ohio, 43210
United States
St. Francis Hospital (Heart Hospital)
Tulsa, Oklahoma, 74136
United States
OHSU Hospital
Portland, Oregon, 97239
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
United States
Medical University of South Carolina
Charleston, South Carolina, 29403
United States
Vanderbilt University
Nashville, Tennessee, 37235
United States
Ascension Seton Medical Center
Austin, Texas, 78701
United States
Baylor St. Luke's Medical Center
Houston, Texas, 77030
United States
University of Virginia
Charlottesville, Virginia, 22908
United States
West Virginia Heart and Vascular
Morgantown, West Virginia, 26508
United States

Collaborators and Investigators

Sponsor: Corvia Medical

  • Sanjiv Shah, MD, PRINCIPAL_INVESTIGATOR, Northwestern Memorial Hospital
  • Martin Leon, MD, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-17
Study Completion Date2031-03

Study Record Updates

Study Start Date2022-11-17
Study Completion Date2031-03

Terms related to this study

Keywords Provided by Researchers

  • Heart failure with preserved ejection fraction (HFpEF)
  • Heart failure with midrange ejection fraction (HFmrEF)
  • Interatrial Shunt

Additional Relevant MeSH Terms

  • Heart Failure
  • Heart Failure, Diastolic