About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Hospitalization for heart failure (de novo or decompensated chronic heart failure) irrespective of left ventricular ejection fraction
Age 18-99
Accept to participate
Disqualifiers
A prior history of upper extremity venous disease
Serum creatinine ≥ 3.5 mg/dL
Severe stenotic valvular disease
Hypertrophic obstructive cardiomyopathy
Trial design
Parallel
Treatments tested in this trial
Diuretic therapy
DrugDiuretic therapy will be tailored according to peripheral venous pressure targets or standard approach
Treatment groups
Trial outcomes
Primary outcomes
Primary end point: Major adverse events (Mortality and rehospitalization)
The difference in the combined rate of all-cause mortality, all-cause hospitalization and all-cause emergency department visits
Secondary outcomes
Secondary combined end point:Major cardiac adverse events (Cardiac mortality and hospitalization)
The difference in the combined rate of cardiovascular mortality, HF-related hospitalization, HF-related emergency department visits.
Other outcomes
PVP (discharge and delta) and long term outcomes
The correlation between predischarge the absolute amount of pre-discharge peripheral venous pressure (PVP in mmHg) and the change in PVP (in mmHg) during hospital stay and the rate of adverse long-term primary outcomes. (The higher the absolute PVP, more adverse outcomes is hypothesized. The higher the change in PVP during hospital stay, less the rate of adverse events is hypothesized). A multivariable analysis will also be executed for predicting the primary end point.
PVP (delta and cohort) and in-hospital renal outcomes
The correlation between the change in PVP during hospital stay (in mmHg) and the rate of worsening renal function, renal injury, need for dialysis or veno-venous ultrafiltration.
Congestion
The comparison of the two arms in terms of EVEREST congestion score (EVEREST congestion score, range 0-18, the higher the score, the higher the congestion (worse outcome))
Hospital stay
The comparison of the two arms in terms of hospital stay (in days). Longer hospital stay duration is deemed as worse outome.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Başakşehir Çam & Sakura City Hospital
Lead sponsor
Ankara Etlik City Hospital
Collaborator
Akdeniz University
Collaborator
Bağcılar Training and Research Hospital
Collaborator
Bakırçay University, Faculty of Medicine
Collaborator
Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
Collaborator
Eskişehir City Hospital
Collaborator
İdil State Hospital
Collaborator
Kafkas University Health Research and Application Hospital
Collaborator
Kutahya Health Sciences University
Collaborator
Istanbul Mehmet Akif Ersoy Educational and Training Hospital
Collaborator
Pazarcık State Hospital
Collaborator
Tokat Gaziosmanpasa University
Collaborator
Trakya University
Collaborator
Ataturk University
Collaborator