PVP-Guided Decongestive Therapy in HF 2

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-99
SponsorBaşakşehir Çam & Sakura City Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Diuretic therapy

    Drug

    Diuretic therapy will be tailored according to peripheral venous pressure targets or standard approach

Treatment groups

650 Participants
are divided into 2 treatment groups
Group A: PVP-GuidedExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
One year

Secondary outcomes

1

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.

Time frame
One year

Other outcomes

1

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.

Time frame
One year
2

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.

Time frame
One year
3

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))

Time frame
One year
4

Hospital stay

The comparison of the two arms in terms of hospital stay (in days). Longer hospital stay duration is deemed as worse outome.

Time frame
One year

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