Actively Recruiting

Phase 4
Age: 18Years - 99Years
All Genders
ID06495892

Peripheral Venous Pressure-Guided Decongestive Therapy in Heart Failure 2

Led by Başakşehir Çam & Sakura City Hospital · Updated on 2024-12-04

650

Participants Needed

16

Research Sites

52 weeks

Total Duration

On this page

Sponsors

B

Başakşehir Çam & Sakura City Hospital

Lead Sponsor

A

Ankara Etlik City Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Brief Title

PVP-Guided Decongestive Therapy in HF 2

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Hospitalization for heart failure (new or worsened chronic heart failure) regardless of heart function
  • Age between 18 and 99 years
  • Willingness to participate and provide informed consent
Not Eligible

You will not qualify if you...

  • History of upper extremity venous disease
  • Serum creatinine level 3.5 mg/dL or higher
  • Severe stenotic valvular disease
  • Hypertrophic obstructive cardiomyopathy
  • Withdrawal of consent
  • Presence of an indwelling central venous catheter
  • Implanted left ventricular assist device
  • History of heart transplantation
  • Clinical diagnosis of cardiogenic shock
  • Any right-to-left heart shunt

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Treatment

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

Follow-up

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

Trial Site Locations

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

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Research Team

E

Emre K Aslanger, Prof

Ö

Özlem Yıldırımtürk, Prof

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

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/30600580