Monitoring of the Influence of Approved PH-therapies RV-PA Coupling

NCT05935865 | Recruiting

• 1 other identifier: 211/22
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn about the acute (days) changes in right ventricular functions caused by initiation of pharmacological therapies in patients with precapillary pulmonary hypertension. The main question it aims to answer is: • Course of afterload and intrinsic contractility throughout the hospital stay Participants will be equipped with a device for continuous monitoring and recording of the right ventricular pressure signal.

Conditions

Pulmonary Hypertension

Keywords

Monitoring; RV-PA Coupling; Pulmonary Hypertension; Right Ventricle

Outcome Measures

Primary Outcomes (4)

• Afterload

  Responce of afterload (calculated from PV loops \[Ea\]) afterload during hospitalization to the initiation or escalation of pulmonary vascular therapy

  3-7days

• Contractility

  Response of contractility (calculated from PV loops \[Ees\]) during hospitalization to the initiation or escalation of pulmonary vascular therapy

  3-7days

• Coupling

  Response of Coupling (calculated from PV loops \[Ees/Ea\]) during hospitalization to the initiation or escalation of pulmonary vascular therapy

  3-7days

• Validation of Echo/CorLog PV-Loops

  Validation of Echo/Corlog-generated PV loops based on conductance catheter-generated PV loops

  On first day

Secondary Outcomes (2)

• Validation of pressure-only methods

  3-7days

• Contraction patterns

  3-7 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes patients with pre-capillary pulmonary hypertension (Nice classification groups 1, 3, or 4) who are scheduled to undergo right heart catheterization for clinical reasons as part of invasive diagnostics for: 1. Establishing a diagnosis when there is a non-invasive suspicion of pulmonary hypertension. 2. Performing invasive hemodynamic assessment in patients already receiving vasoactive therapy, with the question of therapy escalation, particularly in cases of right cardiac decompensation.

You may qualify if:

• Initial diagnosis of PH (treatment-naive incident PH) of the Nice classifications 1 (PAH), 3 (PH related to lung diseases/hypoxia), and 4 (CTEPH), or known PH under ongoing vasoreactive therapy
• No contraindications for right heart catheterization, conductance catheterization, or CorLog implantation
• Written consent from the patient or their legal guardian

You may not qualify if:

• Absence of written consent
• Age \< 18 years
• Presence of contraindications for right heart catheterization, conductance catheterization, or CorLog implantation
• Pregnancy or breastfeeding

Sponsors & Collaborators

• University of Giessen: lead

Study Sites (1)

Department of Internal Medicine, Justus Liebig University Giessen, Universities of Giessen and Marburg Lung Center (UGMLC), German Center for Lung Research (DZL)

Giessen, Hesse, 35392, Germany

RECRUITING

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Khodr Tello, MD

CONTACT

+49 (0)641 985 56022; khodr.tello@innere.med.uni-giessen.de

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2023
• First Posted: July 7, 2023
• Study Start: February 13, 2023
• Primary Completion: February 13, 2025
• Study Completion: February 13, 2026
• Last Updated: July 7, 2023

Record last verified: 2023-06

Locations

DE (1)