Peripheral Venous Pressure-Guided Decongestive Therapy in Heart Failure

MU-2022-001

The investigators hypothesize that a simple assessment of peripheral venous pressure (PVP) will better predict the diuretic need and long-term outcomes (all cause mortality, all cause rehospitalization, emergency department visits) compared to standard evaluation.

2022-01-01

2024-01-01

2024-01-01

Recruiting

Early phase I

586

Inclusion criteria * Hospitalization for heart failure (de novo or decompensated chronic heart failure) * Age \>18 Exclusion criteria * A prior history of upper extremity venous disease * Serum creatinine ≥ 3.5 mg/dL * Severe stenotic valvular disease * Hypertrophic obstructive cardiomyopathy Exclusion from long term follow-up after randomization * Unable to obtain first and pre-discharge PVP due to technical issues (unable to access an upper extremity vein, negative augmentation test) * In-hospital intubation * Need for high-dose vasopressor or inotrope medications (≥10 mcg.kg.-1.min-1 dopamine, dobutamine or equivalent) * Need for intra-aortic balloon pump support * In-hospital need for dialysis or veno-venous ultrafiltration

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two arms with a standard care control group and a peripheral pressure guided intervention group', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 586, 'type': 'ESTIMATED'}}

2023-03-14