Alleviate-HF-1 Study
Heart Failure
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
- Documented history of NYHA Class II, Class III or ambulatory Class IV at the screening visit.
- History of at least one hospitalization for treatment of heart failure within the past 12 months.
- LVEF greater than 40% as measured by the study-specific transthoracic echocardiography.
Echocardiographic evidence of diastolic dysfunction documented by one or more of the following as measured by the study-specific transthoracic echocardiography protocol performed during screening:
- LA diameter greater than 4 cm
- LA volume index greater than 28 mL
- Lateral e' less than 10 cm/s
- Septal e' less than 8 cm/s
- Lateral E/e' greater than 10
- Septal E/e' greater than 15
- Elevated left atrial pressure WITH a gradient compared to right atrial pressure (RAP) documented by:
(1) end-expiratory PCWP at peak supine cycle ergometer exercise greater than or equa. to 25 mmHg AND (2) PCWP greater than RAP by greater than or equal to 5 mmHg, OR greater than or equal to 10 mmHg increase of end-expiratory PCWP at peak supine cycle ergometer exercise compared to resting PCWP AND PCWP greater than RAP by greater than or equal to 5 mmHg.
Exclusion Criteria:
Presence of advanced heart failure defined as one or more of the following:
- ACC/AHA/ESC Stage D heart failure, non-ambulatory NYHA Class IV HF.
- Cardiac index less than 2.0 L/min/m2.
- Patient is on the cardiac transplant waiting list.
- Inotropic infusion (continuous or intermittent) for EF less than 40% within the past 6 months.
Presence of moderate or worse valve disease, defined as one or more of the following:
- Moderate or worse mitral valve regurgitation or moderate or worse mitral stenosis.
- Moderate or worse tricuspid valve regurgitation.
- Moderate or worse aortic valve disease defined as moderate or worse AS or AI.
. Presence of chronic pulmonary disease defined by one or more of the following:
- Requirement for continuous home oxygen use.
- Hospitalization within the past 12 months for treatment of pulmonary disease.
- Significant chronic pulmonary disease defined as FEV1 less than 50%.
- Documented as currently requiring dialysis or estimated GFR less than 25ml/min/1.73m2
- 6-minute walk distance less than 50 m or greater than 450 m performed during screening.
- Documented atrial fibrillation with ventricular rate greater than 100 BPM at screening.
- Presence of moderate or worse right heart dysfunction OR RV dysfunction defined as TAPSE less than 14 mm or RVFAC less than or equal to 30%
- Presence of pulmonary hypertension with PASP greater than or equal to 70 mmHg OR PVR greater than 4 Wood units.
- Presence of anatomic anomaly that precludes creation of interatrial shunt (including patent foramen ovale, atrial septal defect, target septal thickness greater than 3 mm)
- SBP greater than 170 mmHg at screening.
- Documented left ventricular end diastolic diameter greater than 6 cm.
Sites / Locations
- Tbilisi Heart & Vascular