ALLEVIATE-HF-HD Study
Heart Failure
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
- 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.
- Within 12 months of study entry: ≥ 1 HF hospital admission (with HF as the primary or secondary diagnosis); OR treatment with IV diuretics; 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.
- Site determined echocardiographic LVEF > 25% as measured by the study specific screening transthoracic echo.
Site determined hemodynamic criteria assessed by the screening supine bicycle exercise right heart catheterization test, including each of the components (a)-(b) below:
a. At rest: i. RAP < 14 mmHg ii. PVR < 3.5 Wood units iii. PAS < 70 mmHg iv. Cardiac Index > 1.9 L/min b. At exercise (25-watts): i. PCWP must have a gradient > 5 mmHg of the RA ii. End-expiratory PCWP ≥ 25 mmHg iii. PVR < 1.8 Wood units [if PVR cannot be obtained (e.g., patient stopped pedaling), TPG < 12 mmHg]
Exclusion Criteria:
Presence of advanced heart failure documented in the medical history, defined as one or more of the following:
- ACC/AHA/ESC Stage D heart failure, non-ambulatory NYHA Class IV HF
- Cardiac index < 2.0 L/min/m2
- Inotropic infusion (continuous or intermittent) for EF < 40% within the past 6 months
- Patient is on the cardiac transplant waiting list.
Presence of uncorrected valve disease documented in the medical history and/or confirmed by the study-specific TTE protocol performed during screening, defined as one or more of the following:
- Greater than moderate mitral regurgitation
- Greater than moderate mitral stenosis
- Greater than mild tricuspid regurgitation
- Greater than moderate aortic stenosis
- Greater than moderate aortic regurgitation
- Presence of clinically significant untreated carotid artery stenosis documented in the medical history that is likely to require intervention.
- Presence of clinically significant un-revascularized coronary artery disease documented in the medical history that is likely to require intervention, defined as epicardial coronary artery stenosis associated with angina or other evidence of coronary ischemia.
- Presence of hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis or other infiltrative cardiomyopathy such as hemochromatosis or sarcoidosis.
- Presence of uncontrolled tachyarrhythmia documented in the medical history.
Medical history of one or more of the following cardiac procedures:
- MI and/or percutaneous coronary intervention (PCI) within the past 3 months
- CABG within the past 3 months
- SAVR or TAVR within the past 6 months
- MVR or TMVR within the past 6 months
- Medical history of any implanted pacemaker device.
- Medical history of cardiac ablation procedure (either for atrial or ventricular arrhythmias) within the past 3 months.
Presence of chronic pulmonary disease documented in the medical history, defined by one or more of the following:
- Current requirement for continuous home oxygen use
- Hospitalization within the past 12 months for treatment of chronic pulmonary disease
- Significant chronic pulmonary disease defined as FEV1 < 50% of predicted
- If COPD is documented in the medical history and the patient is taking oral or inhaled COPD medication at the time of screening, then a spirometry test is to be performed and patient excluded if FEV1 < 50%.
- Presence of pulmonary hypertension with PASP ≥ 70 mmHg OR PVR > 3.5 Wood units at rest, documented in the medical history or diagnosed during the initial right heart catheterization.
Sites / Locations
- Tbilisi Heart and Vascular