REDUCE LAP-HF TRIAL II

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 17-002171
    NCT ID: NCT03088033
    Sponsor Protocol Number: 1601

About this study

Multicenter, Prospective, Randomized Controlled, Blinded Trial, with a Non-implant Control group; 1:1 randomization.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

Candidates for the study must meet ALL of the following inclusion criteria:

  1. Chronic symptomatic heart failure (HF) documented by the following:
    1. Symptoms of HF requiring current treatment with diuretics for ≥ 30 days AND
    2. New York Heart Association (NYHA) class II if a prior history of > NYHA class II; OR NYHA class III, or ambulatory NYHA class IV symptoms (paroxysmal nocturnal dyspnea, orthopnea, dyspnea on mild or moderate exertion) at screening visit; or signs (any rales post cough, chest x-ray demonstrating pulmonary congestion,) within past 12 months; AND
    3. ≥ 1 HF hospital admission (with HF as the primary, or secondary diagnosis); or treatment with intravenous (IV); or the need for intensification of oral diuresis for HF in a healthcare facility within the 12 months prior to study entry; OR an NT-pro BNP value > 150 pg./ml in normal sinus rhythm, > 450 pg./ml in atrial fibrillation, or a BNP value > 50 pg./ml in normal sinus rhythm, > 150 pg./ml in atrial fibrillation within the past 6 months.
  2. Ongoing stable GDMT HF management and management of potential comorbidities according to the 2017 ACCF/AHA Guidelines for the management of Heart Failure, with no significant changes (>100% increase or 50% decrease), excluding diuretic dose changes, for a minimum of 4 weeks prior to enrollment which is expected to be maintained for 6 months. Stable management includes a minimum period of 4 weeks post hospitalization for any cause, including treatment with IV diuretics.
  3. Age ≥ 40 years old
  4. Site determined echocardiographic LV ejection fraction ≥40% within the past 6 months, without documented ejection fraction <30% in the 5 years prior to study entry.
  5. Site determined elevated PCWP with a gradient compared to right atrial pressure (RAP) documented by:
    1. End-expiratory PCWP during supine ergometer exercise ≥ 25mm Hg, and greater than RAP by ≥ 5 mm Hg. OR
    2. End-expiratory resting PCWP >15mm Hg, and greater than RAP by ≥ 5 mm Hg.
  6. Site determined echocardiographic evidence of diastolic dysfunction documented by one or more of the following:
    1. LA diameter > 4 cm; or
    2. Diastolic LA volume > 50, LA volume index > 28 ml/m2 or
    3. Lateral e’ < 10 cm/s; or
    4. Septal e’ < 8 cm/s; or
    5. Lateral E/e’ > 10; or
    6. Septal E/e’ > 15
  7. Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the IRB or EC
  8. Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams
  9. Trans-septal catheterization and femoral vein access to the right atrium is determined to be feasible by site interventional cardiology investigator.

Exclusion Criteria:

Candidates for this study will be excluded if ANY of the following conditions are present:

  1. MI and/or percutaneous cardiac intervention within past 3 months; CABG in past 3 months, or current indication for coronary revascularization; AVR (surgical AVR or TAVR) within the past 12 months.
  2. Cardiac resynchronization therapy initiated within the past 6 months
  3. Advanced heart failure defined as one or more of the below:
    1. ACC/AHA/ESC Stage D heart failure, Non-ambulatory NYHA Class IV HF;
    2. Cardiac index < 2.0 L/min/m2
    3. Inotropic infusion (continuous or intermittent) for EF < 40% within the past 6 months
    4. Patient is on the cardiac transplant waiting list
  4. Inability to perform 6 minute walk test (distance < 50 m), OR 6 minute walk test > 600m
  5. 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.
  6. Unwilling or unable (per PhysIQ protocol) to wear tele-monitoring patch.
  7. Known clinically significant un-revascularized coronary artery disease, defined as: epicardial coronary artery stenosis associated with angina or other evidence of coronary ischemia.
  8. History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 6 months
  9. Known clinically significant untreated carotid artery stenosis likely to require intervention.
  10. Presence of hemodynamically significant valve disease assessed by the site cardiologist and defined as:
    1. Mitral valve disease defined as grade ≥ 3+ MR or > mild MS; OR
    2. Tricuspid valve regurgitation defined as grade ≥ 2+ TR; OR
    3. Aortic valve disease defined as ≥ 2+ AR or > moderate AS
  11. Hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis or other infiltrative cardiomyopathy (e.g. hemochromatosis, sarcoidosis)
  12. Subject is contraindicated to receive either dual antiplatelet therapy or warfarin (analogue); or has a documented coagulopathy
  13. Atrial fibrillation with resting HR > 100 BPM
  14. Resting arterial oxygen saturation < 95% on room air
  15. Significant hepatic impairment defined as 3X upper limit of normal of transaminases, total bilirubin, or alkaline phosphatase
  16. Right ventricular dysfunction, assessed by the site cardiologist and defined as
    1. More than mild RV dysfunction as estimated by TTE; OR
    2. TAPSE < 1.4 cm; OR
    3. RV size ≥ LV size as estimated by TTE; OR
    4. Ultrasound or clinical evidence of congestive hepatopathy; OR
    5. Evidence of RV dysfunction defined by TTE as an RV fractional area change < 35%;
  17. Resting RAP > 14 mmHg
  18. Evidence of significant pulmonary hypertension defined as PVR > 4 Wood units at rest or with exercise
  19. Chronic pulmonary disease requiring continuous home oxygen, OR significant chronic pulmonary disease defined as FEV1 <1L.
  20. Hemoglobin <10 g/dl
  21. 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
  22. Life expectancy less than 12 months for known non-cardiovascular reasons
  23. Echocardiographic evidence of intra-cardiac mass, thrombus or vegetation
  24. Known or suspected allergy to nickel
  25. Fertile women not using contraceptives
  26. Currently requiring dialysis; or estimated-GFR <25ml/min/1.73 m2 by CKD-Epi equation
  27. Systolic blood pressure >170 mm Hg.
  28. Subjects with existing or surgically closed (with a patch) atrial septal defects. Subjects with a patent foramen ovale (PFO), who meet PCWP criteria despite the PFO, are not excluded.
  29. Subjects on significant immunosuppressive treatment or on systemic steroid treatment (>10 mg prednisone/day).
  30. Severe obstructive sleep apnea not treated with CPAP or other measures
  31. Severe depression and/or anxiety
  32. In the opinion of the investigator, the subject is not an appropriate candidate for the study

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Barry Borlaug, M.D.

Open for enrollment

Contact information:

Diane Ryberg R.N.

(507)266-4095

HansonRyberg.Diane@mayo.edu

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CLS-20343897

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