Using peripheral venous pressure to guide diuretic therapy in heart failure patients
Peripheral Venous Pressure-Guided Decongestive Therapy in Heart Failure 2
PHASE4 · Başakşehir Çam & Sakura City Hospital · NCT06495892
This study is testing if measuring peripheral venous pressure can help doctors decide when heart failure patients need diuretics to improve their recovery and reduce the chances of going back to the hospital.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 650 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Başakşehir Çam & Sakura City Hospital (other gov) |
| Locations | 16 sites (Ankara and 15 other locations) |
| Trial ID | NCT06495892 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of using peripheral venous pressure (PVP) assessments to better predict the need for diuretic therapy and improve long-term outcomes in patients hospitalized for heart failure. The study aims to determine if PVP can serve as a reliable bedside tool for evaluating volume status, potentially leading to reduced rates of rehospitalization and mortality. Patients aged 18 to 99 who are admitted with heart failure will be enrolled, and their outcomes will be compared against standard evaluation methods. The trial is being conducted at multiple hospitals in Turkey.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-99 who are hospitalized for de novo or decompensated chronic heart failure.
Not a fit: Patients with severe renal impairment, certain heart conditions, or those with prior venous disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved management of heart failure patients, reducing hospital readmissions and mortality rates.
How similar studies have performed: While the use of PVP in this context is relatively novel, previous studies have indicated its potential effectiveness in assessing volume status in heart failure patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria * Hospitalization for heart failure (de novo or decompensated chronic heart failure) irrespective of left ventricular ejection fraction * Age 18-99 * Accept to participate Exclusion criteria * A prior history of upper extremity venous disease * Serum creatinine ≥ 3.5 mg/dL * Severe stenotic valvular disease * Hypertrophic obstructive cardiomyopathy * Withdrawal of consent * Indwelling central venous catheter, * Implanted left ventricular assist device * History of heart transplantation * Clinical diagnosis of cardiogenic shock * Any right-to-left shunt
Where this trial is running
Ankara and 15 other locations
- Ankara Etlik City Hospital — Ankara, Turkey (Türkiye) (RECRUITING)
- Antalya Atatürk State Hospital — Antalya, Turkey (Türkiye) (RECRUITING)
- Akdeniz University — Antalya, Turkey (Türkiye) (ACTIVE_NOT_RECRUITING)
- Trakya University — Edirne, Turkey (Türkiye) (RECRUITING)
- Erzurum Atatürk University Hospital — Erzurum, Turkey (Türkiye) (RECRUITING)
- Eskişehir City Hospital — Eskişehir, Turkey (Türkiye) (RECRUITING)
- Mehmet Akif Ersoy Training and Research Hospital — Istanbul, Turkey (Türkiye) (RECRUITING)
- Basaksehir Cam and Sakura City Hospital — Istanbul, Turkey (Türkiye) (RECRUITING)
- Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital — Istanbul, Turkey (Türkiye) (RECRUITING)
- Bağcılar Training and Research Hospital — Istanbul, Turkey (Türkiye) (RECRUITING)
- Bakırçay University, Faculty of Medicine — Izmir, Turkey (Türkiye) (RECRUITING)
- Pazarcık State Hospital — Kahramanmaraş, Turkey (Türkiye) (TERMINATED)
- Kafkas University Health Research and Application Hospital — Kars, Turkey (Türkiye) (RECRUITING)
- Kütahya Health Sciences University — Kütahya, Turkey (Türkiye) (RECRUITING)
- İdil State Hospital — Şırnak, Turkey (Türkiye) (RECRUITING)
- Tokat Gaziosmanpaşa University — Tokat Province, Turkey (Türkiye) (RECRUITING)
Study contacts
- Principal investigator: Emre K Aslanger, Prof — Basaksehir Pine and Sakura City Hospital
- Study coordinator: Emre K Aslanger, Prof
- Email: mr_aslanger@hotmail.com
- Phone: +90 (212) 909 60 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Failure, Congestion, Congestive Heart Failure