Status:
COMPLETED
Alleviate-HF-2 Study
Lead Sponsor:
Alleviant Medical, Inc.
Conditions:
Heart Failure
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
Patients with heart failure and preserved left ventricular ejection fraction (HFpEF, EF ≥ 50%) or mid-range left ventricular ejection fraction (HFmrEF, 40% \< EF \< 50%) with mild to moderate function...
Eligibility Criteria
Inclusion
- NYHA Class II at screening with a prior history of greater than NYHA Class II, OR NYHA Class III at screening, OR ambulatory Class IV at screening: with documented medical history of heart failure for at least 6 months prior to the screening visit.
- Medical history within the past 12 months of at least one hospitalization with heart failure as the primary or secondary diagnosis OR treatment with IV diuretics for heart failure..
- LVEF (by Echo) \> 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:
- LA diameter \> 4cm
- LA volume index \>28 mL
- Lateral e' \<10 cm/s
- Septal e' \<8 cm/s
- Lateral E/e' \>10
- Septal E/e' \>15
- As measured by the study-specific exercise hemodynamic right heart catheterization protocol performed during screening: 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 ≥ 25mmHg AND (2) PCWP greater than RAP by ≥ 5 mmHg, OR (1) ≥ 10 mmHg increase of end-expiratory PCWP at peak supine cycle ergometer exercise compared to resting PCWP AND (2) PCWP greater than RAP by ≥ 5 mmHg. Patients must also have PCWP greater than RAP by ≥ 5 mmHg at rest.
Exclusion
- 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.
Key Trial Info
Start Date :
April 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04838353
Start Date
April 3 2021
End Date
December 31 2023
Last Update
October 4 2024
Active Locations (5)
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1
Flinders Medical Centre
Adelaide, Australia
2
Monash Medical Centre
Clayton, Australia
3
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Canada
4
Southern District Health Board
Dunedin, New Zealand