PVP-Guided Decongestive Therapy in HF 2
NCT Number: NCT06495892
Acronym: PERIPHERAL-HF2
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Heart Failure|Congestion|Congestive Heart Failure
Interventions: DRUG: Diuretic therapy
Sponsor: Başakşehir Çam & Sakura City Hospital
Collaborators: Ankara Etlik City Hospital|Akdeniz University|Bağcılar Training and Research Hospital|Bakırçay University, Faculty of Medicine|Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital|Eskişehir City Hospital|İdil State Hospital|Kafkas University Health Research and Application Hospital|Kutahya Health Sciences University|Istanbul Mehmet Akif Ersoy Educational and Training Hospital|Pazarcık State Hospital|Tokat Gaziosmanpaşa University, Faculty of Medicine|Trakya University Faculty of Medicine|Ataturk University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 650
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2026-07-01
Locations: Ankara Etlik City Hospital, Ankara, 6010, Turkey|Antalya Atatürk State Hospital, Antalya, 07040, Turkey|Akdeniz University, Antalya, 07070, Turkey|Trakya University, Edirne, 22030, Turkey|Erzurum Atatürk University Hospital, Erzurum, 25040, Turkey|Eskişehir City Hospital, Eskişehir, 26080, Turkey|Mehmet Akif Ersoy Training and Research Hospital, Istanbul, 34303, Turkey|Basaksehir Cam and Sakura City Hospital, Istanbul, 3440, Turkey|Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, 34668, Turkey|Bağcılar Training and Research Hospital, Istanbul, Turkey|Bakırçay University, Faculty of Medicine, Izmir, 35665, Turkey|Pazarcık State Hospital, Kahramanmaraş, 46700, Turkey|Kafkas University Health Research and Application Hospital, Kars, 36100, Turkey|Kütahya Health Sciences University, Kütahya, 43100, Turkey|Tokat Gaziosmanpaşa University, Tokat, 60030, Turkey|İdil State Hospital, Şırnak, 73300, Turkey

Summary:
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.

Primary Outcome Measures: 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, One year
Secondary Outcome Measures: 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., One year
Other Outcome Measures: 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., One year|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., One year|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)), One year|Hospital stay, The comparison of the two arms in terms of hospital stay (in days). Longer hospital stay duration is deemed as worse outome., One year