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 rehospitalization, emergency department visits) compared to standard evaluation.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

650

participants targeted

Target at P75+ for phase_4 heart-failure

Timeline

1mo left

Started Jul 2024

Geographic Reach

1 country

16 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2 years study duration

Study Progress93%

Jul 2024Jul 2026

First Submitted

Initial submission to the registry

June 25, 2024

Completed

6 days until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed

10 days until next milestone

First Posted

Study publicly available on registry

July 11, 2024

Completed

12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected

Last Updated

December 4, 2024

Status Verified

December 1, 2024

Enrollment Period

1 year

First QC Date

June 25, 2024

Last Update Submit

December 1, 2024

Conditions

Heart Failure Congestion Congestive Heart Failure

Outcome Measures

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
One year

Secondary Outcomes (1)

Secondary combined end point:Major cardiac adverse events (Cardiac mortality and hospitalization)
One year

Other Outcomes (4)

PVP (discharge and delta) and long term outcomes
One year
PVP (delta and cohort) and in-hospital renal outcomes
One year
Congestion
One year
+1 more other outcomes

Study Arms (2)

PVP-Guided

EXPERIMENTAL

Peripheral venous pressure guided diuretic therapy arm

Drug: Diuretic therapy

Control

ACTIVE COMPARATOR

Standard dıuretic therapy arm

Drug: Diuretic therapy

Interventions

Diuretic therapyDRUG

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

ControlPVP-Guided

Eligibility Criteria

Age18 Years - 99 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Hospitalization for heart failure (de novo or decompensated chronic heart failure) irrespective of left ventricular ejection fraction
Age 18-99
Accept to participate

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Başakşehir Çam & Sakura City Hospitallead
Ankara Etlik City Hospitalcollaborator
Akdeniz Universitycollaborator
Bağcılar Training and Research Hospitalcollaborator
Bakırçay University, Faculty of Medicinecollaborator
Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospitalcollaborator
Eskişehir City Hospitalcollaborator
İdil State Hospitalcollaborator
Kafkas University Health Research and Application Hospitalcollaborator
Kutahya Health Sciences Universitycollaborator
Istanbul Mehmet Akif Ersoy Educational and Training Hospitalcollaborator
Pazarcık State Hospitalcollaborator
Tokat Gaziosmanpaşa University, Faculty of Medicinecollaborator
Trakya Universitycollaborator
Ataturk Universitycollaborator

Study Sites (16)

Ankara Etlik City Hospital

Ankara, 6010, Turkey (Türkiye)

RECRUITING

Antalya Atatürk State Hospital

Antalya, 07040, Turkey (Türkiye)

RECRUITING

Akdeniz University

Antalya, 07070, Turkey (Türkiye)

ACTIVE NOT RECRUITING

Trakya University

Edirne, 22030, Turkey (Türkiye)

RECRUITING

Erzurum Atatürk University Hospital

Erzurum, 25040, Turkey (Türkiye)

RECRUITING

Eskişehir City Hospital

Eskişehir, 26080, Turkey (Türkiye)

RECRUITING

Mehmet Akif Ersoy Training and Research Hospital

Istanbul, 34303, Turkey (Türkiye)

RECRUITING

Basaksehir Cam and Sakura City Hospital

Istanbul, 3440, Turkey (Türkiye)

RECRUITING

Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital

Istanbul, 34668, Turkey (Türkiye)

RECRUITING

Bağcılar Training and Research Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Bakırçay University, Faculty of Medicine

Izmir, 35665, Turkey (Türkiye)

RECRUITING

Pazarcık State Hospital

Kahramanmaraş, 46700, Turkey (Türkiye)

TERMINATED

Kafkas University Health Research and Application Hospital

Kars, 36100, Turkey (Türkiye)

RECRUITING

Kütahya Health Sciences University

Kütahya, 43100, Turkey (Türkiye)

RECRUITING

İdil State Hospital

Şırnak, 73300, Turkey (Türkiye)

RECRUITING

Tokat Gaziosmanpaşa University

Tokat Province, 60030, Turkey (Türkiye)

RECRUITING

Related Publications (2)

Mullens W, Damman K, Harjola VP, Mebazaa A, Brunner-La Rocca HP, Martens P, Testani JM, Tang WHW, Orso F, Rossignol P, Metra M, Filippatos G, Seferovic PM, Ruschitzka F, Coats AJ. The use of diuretics in heart failure with congestion - a position statement from the Heart Failure Association of the European Society of Cardiology. Eur J Heart Fail. 2019 Feb;21(2):137-155. doi: 10.1002/ejhf.1369. Epub 2019 Jan 1.
PMID: 30600580BACKGROUND
Aslanger EK, Pamuk FO, Islamoglu Y, Ozates YS, Ilis D, Donmez E, Ozcan S, Babayigit EC, Demir M, Sen T, Yildirimturk O; PERIPHERAL-HF2 Investigators. Peripheral Venous Pressure-Guided Decongestive Therapy in Heart Failure 2 (PERIPHERAL-HF2). Am J Cardiol. 2025 Apr 15;241:37-42. doi: 10.1016/j.amjcard.2025.01.018. Epub 2025 Jan 22.
PMID: 39855451DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

Emre K Aslanger, Prof
Basaksehir Pine and Sakura City Hospital
PRINCIPAL INVESTIGATOR
Özlem Yıldırımtürk, Prof
Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
PRINCIPAL INVESTIGATOR

Central Study Contacts

Emre K Aslanger, Prof

CONTACT

+90 (212) 909 60 00 mr_aslanger@hotmail.com

Özlem Yıldırımtürk, Prof

CONTACT

ozlemyt@gmail.com

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER GOV
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 25, 2024

First Posted

July 11, 2024

Study Start

July 1, 2024

Primary Completion

July 1, 2025

Study Completion (Estimated)

July 1, 2026

Last Updated

December 4, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing: Will not share

Locations

TU(16)

PVP-Guided Decongestive Therapy in HF 2

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (4)

Study Arms (2)

PVP-Guided

Control

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (16)

Related Publications (2)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (4)

Study Arms (2)

PVP-Guided

Control

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (16)

Related Publications (2)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations