Multimodality RV Phenotyping for Risk Stratification and Short-Term Outcomes in Group 1 PAH

NCT07667673 | Recruiting

• 1 other identifier: 2026/171
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The MIRROR-PAH is a single-center, prospective, observational cohort study evaluating the incremental value of multimodality imaging-derived right ventricular characteristics for risk stratification in patients with Group 1 pulmonary arterial hypertension (PAH). The study aims to determine whether incorporation of echocardiographic and cardiac magnetic resonance (CMR)-derived right ventricular parameters into established non-invasive risk assessment models results in risk reclassification and improves identification of patients at risk for short-term clinical worsening. Adult patients with established Group 1 PAH undergoing routine follow-up and with available right heart catheterization (RHC) and CMR data will be consecutively enrolled. Clinical, laboratory, echocardiographic, and follow-up data will be prospectively collected over a 6-month period. Associations between multimodality imaging findings, invasive hemodynamic measurements, risk classification, and short-term clinical outcomes will be evaluated.

Conditions

Pulmonary Hypertension; Right Ventricular Function; Pulmonary Arterial Hypertension

Keywords

pulmonary arterial hypertension; transthoracic echocardiography; cardiac magnetic resonance imaging; right heart catheterization; risk stratification

Outcome Measures

Primary Outcomes (1)

• Risk reclassification rate after incorporation of multimodality imaging-derived RV characteristics into established non-invasive PAH risk models

  The proportion of patients undergoing risk reclassification after incorporation of multimodality imaging-derived right ventricular (RV) characteristics obtained from echocardiography and cardiac magnetic resonance imaging into established non-invasive PAH risk assessment models will be evaluated. Changes in risk category assignment compared with conventional non-invasive risk stratification will be assessed.

  Baseline and 6-month follow-up

Secondary Outcomes (6)

• Number of Participants Experiencing Composite Clinical Worsening

  6 months

• Change in Predictive Performance for Composite Clinical Worsening After Addition of RV Imaging Characteristics to Conventional PAH Risk Classification

  6 months

• RV imaging characteristics associated with clinical worsening

  6 months

• Agreement Between Cardiovascular Magnetic Resonance-Derived Stroke Volume Index and Right Heart Catheterization-Derived Stroke Volume Index

  Baseline

• RV imaging characteristics associated with high-risk status

  Baseline and 6-month follow-up

Study Arms (1)

Patients with Group 1 Pulmonary Arterial Hypertension

Participants are adult patients with established Group 1 pulmonary arterial hypertension (PAH) undergoing follow-up at a specialized pulmonary hypertension center.

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

Adult patients with established Group 1 pulmonary arterial hypertension (PAH) undergoing routine follow-up at a specialized pulmonary hypertension center. Eligible participants will have available right heart catheterization (RHC), transthoracic echocardiography, and cardiac magnetic resonance (CMR) imaging data and will undergo prospective clinical and echocardiographic follow-up for 6 months.

You may qualify if:

• Adults aged 18 years or older
• Diagnosis of Group 1 pulmonary arterial hypertension (PAH) according to ESC/ERS guidelines
• Followed at the study center with a diagnosis of PAH
• Availability of right heart catheterization (RHC) and cardiac magnetic resonance (CMR) imaging data obtained within a clinically relevant time interval
• Availability of analyzable clinical, imaging, and hemodynamic data
• Willingness to participate in the study and provision of written informed consent

You may not qualify if:

• Age younger than 18 years
• Pulmonary hypertension groups other than Group 1 PAH (Groups 2-5 PH)
• Absence of either right heart catheterization or cardiac magnetic resonance imaging data within a clinically relevant time interval
• Incomplete clinical or imaging data preventing analysis
• Unavailable follow-up data

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University Cerrahpasa Institute of Cardiology

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• Lewis RA, Johns CS, Cogliano M, Capener D, Tubman E, Elliot CA, Charalampopoulos A, Sabroe I, Thompson AAR, Billings CG, Hamilton N, Baster K, Laud PJ, Hickey PM, Middleton J, Armstrong IJ, Hurdman JA, Lawrie A, Rothman AMK, Wild JM, Condliffe R, Swift AJ, Kiely DG. Identification of Cardiac Magnetic Resonance Imaging Thresholds for Risk Stratification in Pulmonary Arterial Hypertension. Am J Respir Crit Care Med. 2020 Feb 15;201(4):458-468. doi: 10.1164/rccm.201909-1771OC.

  PMID: 31647310 BACKGROUND

• Dardi F, Boucly A, Benza R, Frantz R, Mercurio V, Olschewski H, Radegran G, Rubin LJ, Hoeper MM. Risk stratification and treatment goals in pulmonary arterial hypertension. Eur Respir J. 2024 Oct 31;64(4):2401323. doi: 10.1183/13993003.01323-2024. Print 2024 Oct.

  PMID: 39209472 BACKGROUND

• Humbert M, Kovacs G, Hoeper MM, Badagliacca R, Berger RMF, Brida M, Carlsen J, Coats AJS, Escribano-Subias P, Ferrari P, Ferreira DS, Ghofrani HA, Giannakoulas G, Kiely DG, Mayer E, Meszaros G, Nagavci B, Olsson KM, Pepke-Zaba J, Quint JK, Radegran G, Simonneau G, Sitbon O, Tonia T, Toshner M, Vachiery JL, Vonk Noordegraaf A, Delcroix M, Rosenkranz S; ESC/ERS Scientific Document Group. 2022 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension. Eur Respir J. 2023 Jan 6;61(1):2200879. doi: 10.1183/13993003.00879-2022. Print 2023 Jan. No abstract available.

  PMID: 36028254 BACKGROUND

MeSH Terms

Conditions

Hypertension, Pulmonary; Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

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

Study Officials

• Aybüke Geylan, MD

  Istanbul University Cerrahpasa Institute of Cardiology

  PRINCIPAL INVESTIGATOR

• Umit Yasar Sinan, Professor

  Istanbul University Cerrahpasa Institute of Cardiology

  STUDY CHAIR

Central Study Contacts

Aybüke Geylan, MD

CONTACT

+905061258579; aybukegeylan@gmail.com

Barış Güven, MD

CONTACT

+905321137507; guvenbariss@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 6, 2026
• First Posted: June 25, 2026
• Study Start: May 11, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 25, 2026

Record last verified: 2026-06

Locations

TU (1)