The use of diuretics in heart failure with congestion - a position statement from the Heart Failure Association of the European Society of Cardiology.
Wilfried Mullens, Kevin Damman, Veli-Pekka Harjola...
https://pubmed.ncbi.nlm.nih.gov/30600580Actively Recruiting
Led by Başakşehir Çam & Sakura City Hospital · Updated on 2024-12-04
650
Participants Needed
16
Research Sites
52 weeks
Total Duration
B
Başakşehir Çam & Sakura City Hospital
Lead Sponsor
A
Ankara Etlik City Hospital
Collaborating Sponsor
Researchers are evaluating whether measuring peripheral venous pressure (PVP) can better guide the need for diuretic treatment and improve long-term outcomes such as mortality, hospital readmissions, and emergency visits in patients hospitalized with heart failure compared to standard evaluation methods. This study focuses on adults aged 18 to 99 with new or worsened chronic heart failure, regardless of heart function or cause. The trial aims to address the challenge of persistent congestion after hospital discharge, which contributes to high readmission and death rates. Participants will be randomly assigned to two groups: one receiving diuretic therapy guided by PVP measurements aiming for a PVP less than 9 mmHg before discharge, and the other receiving standard diuretic therapy based on physician judgment. Peripheral IV lines will be placed to measure PVP using a defined procedure, and treatment will follow European Society of Cardiology guidelines. Patients unable to have PVP measured or requiring intensive support will be excluded. The study will last one year, with follow-up to track major adverse events including death and hospital readmissions. During the study, participants will undergo blood sampling, electrocardiogram, echocardiogram, daily monitoring of fluid intake and output, weight, and biochemistry tests. Data will be collected electronically, and PVP measurements taken at admission and before discharge will be analyzed for correlation with outcomes. Researchers will also evaluate kidney function changes and hospitalization patterns. The study involves 650 participants and includes statistical analyses to compare the two treatment approaches over one year.
CONDITIONS
PVP-Guided Decongestive Therapy in HF 2
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You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Duration of hospital stay until discharge
Participants receive diuretic therapy guided either by peripheral venous pressure measurements or standard clinical evaluation during their hospital stay.
Daily assessments during hospital stay
Duration - Up to 1 year
Participants are followed for up to one year after discharge to monitor major adverse events including mortality and rehospitalization.
Outcomes collected via national electronic database; no additional in-person visits required
Total: 16 locations
1
Ankara Etlik City Hospital
Ankara, Turkey (Türkiye), 6010
Actively Recruiting
2
Antalya Atatürk State Hospital
Antalya, Turkey (Türkiye), 07040
Actively Recruiting
3
Akdeniz University
Antalya, Turkey (Türkiye), 07070
Active, Not Recruiting
4
Trakya University
Edirne, Turkey (Türkiye), 22030
Actively Recruiting
5
Erzurum Atatürk University Hospital
Erzurum, Turkey (Türkiye), 25040
Actively Recruiting
6
Eskişehir City Hospital
Eskişehir, Turkey (Türkiye), 26080
Actively Recruiting
7
Mehmet Akif Ersoy Training and Research Hospital
Istanbul, Turkey (Türkiye), 34303
Actively Recruiting
8
Basaksehir Cam and Sakura City Hospital
Istanbul, Turkey (Türkiye), 3440
Actively Recruiting
9
Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
Istanbul, Turkey (Türkiye), 34668
Actively Recruiting
10
Bağcılar Training and Research Hospital
Istanbul, Turkey (Türkiye)
Actively Recruiting
11
Bakırçay University, Faculty of Medicine
Izmir, Turkey (Türkiye), 35665
Actively Recruiting
12
Pazarcık State Hospital
Kahramanmaraş, Turkey (Türkiye), 46700
Terminated
13
Kafkas University Health Research and Application Hospital
Kars, Turkey (Türkiye), 36100
Actively Recruiting
14
Kütahya Health Sciences University
Kütahya, Turkey (Türkiye), 43100
Actively Recruiting
15
İdil State Hospital
Şırnak, Turkey (Türkiye), 73300
Actively Recruiting
16
Tokat Gaziosmanpaşa University
Tokat Province, Turkey (Türkiye), 60030
Actively Recruiting
E
Emre K Aslanger, Prof
Ö
Özlem Yıldırımtürk, Prof
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Wilfried Mullens, Kevin Damman, Veli-Pekka Harjola...
https://pubmed.ncbi.nlm.nih.gov/30600580Emre K Aslanger, Funda Özlem Pamuk, Yaser İslamoğlu...
https://pubmed.ncbi.nlm.nih.gov/39855451