Status:
UNKNOWN
PVP-Guided Decongestive Therapy in HF
Lead Sponsor:
Marmara University
Collaborating Sponsors:
Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
Başakşehir Çam & Sakura City Hospital
Conditions:
Heart Failure
Edema
Eligibility:
All Genders
18-99 years
Phase:
PHASE4
Brief 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 rehospitalizatio...
Detailed Description
I. BACKGROUND AND SIGNIFICANCE Precise assessment of volume status is essential in diagnosis and management of diuretic therapy in patients hospitalized for heart failure (HF). Unfortunately, no clea...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Hospitalization for heart failure (de novo or decompensated chronic heart failure)
- Age \>18
- Exclusion criteria
- A prior history of upper extremity venous disease
- Serum creatinine ≥ 3.5 mg/dL
- Severe stenotic valvular disease
- Hypertrophic obstructive cardiomyopathy
- Exclusion from long term follow-up after randomization
- Unable to obtain first and pre-discharge PVP due to technical issues (unable to access an upper extremity vein, negative augmentation test)
- In-hospital intubation
- Need for high-dose vasopressor or inotrope medications (≥10 mcg.kg.-1.min-1 dopamine, dobutamine or equivalent)
- Need for intra-aortic balloon pump support
- In-hospital need for dialysis or veno-venous ultrafiltration
Exclusion
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2024
Estimated Enrollment :
586 Patients enrolled
Trial Details
Trial ID
NCT05217342
Start Date
January 1 2022
End Date
January 1 2024
Last Update
March 14 2023
Active Locations (5)
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1
Basaksehir Cam & Sakura State Hospital
Istanbul, Turkey (Türkiye)
2
Cerrahpasa University
Istanbul, Turkey (Türkiye)
3
Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
Istanbul, Turkey (Türkiye)
4
Marmara University Pendik Training and Research Hospital
Istanbul, Turkey (Türkiye)