Adult Congenital Heart Disease Registry (QuERI)

NCT01659411 | Completed

• 2 other identifiers: AC-052-433CHRC2011-ACHD001
• Study Type: observational
• Target: 217
• Locations: 0 countries
• Sites: N/A

Brief Summary

Multi-center, observational, U.S.-based longitudinal program. Data will be collected prospectively for 3 years. Individual physician feedback will be provided on data collected with the purpose of improving the management of patients - quality enhancement research initiative (QuERI) process from adult patients enrolled with a history of repaired Congenital Heart Disease (CHD).

Conditions

Pulmonary Arterial Hypertension

Keywords

Congenital Heart Disease; Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

• To characterize the clinical course in a cohort of adult patients with repaired CHD at risk for developing PAH

  outcome measure: clinical outcomes: Assessment of function status, medications, and laboratory results, as well as an evaluation of medical history, physical examination, ECG, and echocardiography, in adult congenital heart disease patients at risk for pulmonary hypertension.

  screening (visit 1) through end of study (3 years)

Secondary Outcomes (1)

• To characterize the clinical outcomes in a cohort of adult patients with repaired CHD at risk for developing PAH

  screening (visit 1) through end of study (3 years)

Study Arms (1)

Adult CHD Patients

observational

Other: Observational

Interventions

Observational OTHER

Yearly clinical visits

Adult CHD Patients

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 CHD patients meeting inclusion and exclusion criteria may be enrolled

You may qualify if:

• Male and female adults (≥ 18 years of age)
• Patients with documented history (at least one year) of an isolated, repaired congenital heart defect such as ASD, VSD, PDA, AVC (AVSD)
• History of a large defect prior to closure as evidenced by any one of the following:
• Size of: ASD \> 2 cm; VSD \> 1 cm; PDA \> 0.6 cm
• Shunt 2:1 or greater
• Pre-operative PH (PAS \> 40 mmHg) or documented shunt- related heart failure (radiographic evidence)
• Pre-operative atrial fibrillation or flutter
• High risk features (any one the following):
• Age \> 40 years
• Later surgical repair:
• i. ≥ 2 years of age for PDA or VSD ii. ≥ 1 year of age for AVC iii. ≥ 10 years of age for ASD
• Sinus venosus defect
• Primum defect
• WHO functional class \> 1
• Atrial fibrillation or flutter

You may not qualify if:

• Poor mental function, drug or substance (e.g., alcohol) abuse, or unstable psychiatric illness, which, in the opinion of the investigator, may interfere with optimal participation in the study
• Diagnosis of PAH (defined as RHC demonstrating mPAP ≥ 25 mm Hg and PCWP ≤ 15 and PVR \> 3 WU or PVR (indexed) \> 4 WU or treatment with PAH specific therapy) after surgical repair and prior to visit 1

Sponsors & Collaborators

• Actelion: lead
• Canadian Heart Research Centre: collaborator

Related Publications (1)

• Landzberg MJ, Daniels CJ, Forfia P, McLaughlin VV, Bell Lynum KS, Selej M, Opotowsky AR. Timely PAH Identification in Adults With Repaired Congenital Heart Disease? The ACHD-QuERI Registry Insights. JACC Adv. 2023 Oct 31;2(9):100649. doi: 10.1016/j.jacadv.2023.100649. eCollection 2023 Nov.

  PMID: 38938704 DERIVED

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Heart Defects, Congenital

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Michael Landzberg, MD

  Harvard Medical School / Boston Adult Congenital Heart

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2012
• First Posted: August 7, 2012
• Study Start: December 1, 2011
• Primary Completion: May 16, 2018
• Study Completion: May 16, 2018
• Last Updated: February 3, 2025

Record last verified: 2025-01