PVP-Guided Decongestive Therapy in HF

NCT05217342 | Unknown Phase 4

• 1 other identifier: MU-2022-001
• Study Type: interventional
• Target: 586
• Locations: 1 country
• Sites: 5

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.

Conditions

Heart Failure; Edema; Volume Overload; Heart Failure，Congestive

Outcome Measures

Primary Outcomes (1)

• Primary combined end point

  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

  One year

Study Arms (2)

PVP-Guided

EXPERIMENTAL

Peripheral venous pressure guided therapy arm

Drug: Diuretic therapy

Control

ACTIVE COMPARATOR

Standard medical therapy arm

Drug: Diuretic therapy

Interventions

Diuretic therapy DRUG

Standard diuretic therapy according to the current guidelines

Control; PVP-Guided

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalization for heart failure (de novo or decompensated chronic heart failure)
• Age \>18

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
• 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

Sponsors & Collaborators

• Marmara University: lead
• Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital: collaborator
• Başakşehir Çam & Sakura City Hospital: collaborator

Study Sites (5)

Basaksehir Cam & Sakura State Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Cerrahpasa University

Istanbul, Turkey (Türkiye)

RECRUITING

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

Istanbul, Turkey (Türkiye)

RECRUITING

Marmara University Pendik Training and Research Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Darıca Farabi Training and Research Hospital

Kocaeli, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Heart Failure; Edema

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Emre K Aslanger, Assoc. Prof.

  Marmara University

  STUDY DIRECTOR

• Dursun Akaslan, MD

  Marmara University

  PRINCIPAL INVESTIGATOR

• Özlem Yıldırımtürk, Prof.

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

  PRINCIPAL INVESTIGATOR

• Duygu İnan, MD

  Basaksehir Cam & Sakura State Hospital

  PRINCIPAL INVESTIGATOR

• Yelda Saltan, MD

  Basaksehir Cam & Sakura State Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emre K Aslanger, Assoc. Prof.

CONTACT

+905325109796; mr_aslanger@hotmail.com

Study Design

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

Model Details: Two arms with a standard care control group and a peripheral pressure guided intervention group

Study Record Dates

• First Submitted: January 1, 2022
• First Posted: February 1, 2022
• Study Start: January 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: March 14, 2023

Record last verified: 2023-03

Locations

TU (5)