REgiStry-based Cardiovascular qUality improvEment Research — RESCUER  

Heart Failure Clinical Trial

Official title: Registry-based Cardiovascular Quality Improvement Research (RESCUER)

Status Recruiting

Clinical Trial Summary

The goal of this registry-based observational study is to establish a comprehensive management plan, which focus on medical therapy, cardiac rehabilitation and active post-market surveillance of medical devices, in patients with cardiovascular diseases (CVD). Patients with CVD mainly refers to four groups of patients：1) post-percutaneous coronary intervention (post-PCI) patients; 2) patients with heart failure (HF); 3) patients with cardiometabolic diseases (CMD); 4) patients with structural heart disease (SHD), and the detailed definition of each group can be found in "Eligibility" section. The main questions this study aims to answer are:

• the effectiveness of exercise-based cardiac rehabilitation in improving cardiac function, reducing CVD recurrence and mortality, and promoting quality of life for patients with CVD;

• the feasibility of registry-based active post-market surveillance of high-risk medical devices used in cardiovascular surgeries, such as PCI, heart valve replacement, and cardiac resynchronization therapy (CRT);

• the utilization of multiomics datasets to identify and dissect cardiovascular heterogeneity in both healthy and diseased populations and to guide precision medicine in patients with CVD;

• the analysis and evaluation of the prescription patterns and drug response in patients with CVD.

Clinical Trial Description

This is a long-term registry, which will continuously enroll patients and approximately 2000 subjects will be enrolled during the first phase.

Primary analyses may include, but will not be limited to, the following: incidence of MACE, procedural complications, and changes in patients' quality of life. Descriptive statistics will be used for baseline, procedure and follow-up data collected through the study.

Each patient will be followed for a period of two years after enrollment according to the schedule and standard practice at Peking University Third Hospital. The follow-up schedule is 2 weeks, 1 month ( additional for HF group), 3 months, 6 months, 12 months, 24 months after discharge. For patients who miss a follow-up visit, a contact (e.g. phone call) will ensure capture of the endpoint related information. In addition, all fatal events will be tracked from the death registry. ;

Related Conditions & MeSH terms

• Cardiometabolic Syndrome
• Heart Failure
• Metabolic Syndrome
• Percutaneous Coronary Intervention
• Structural Heart Abnormality

• NCT number: NCT06137885
• Study type: Observational [Patient Registry]
• Source: Peking University Third Hospital
• Contact: Yueyue Xi
• Phone: 18611707034
• Email: 18611707034@163.com
• Status: Recruiting
• Start date: April 24, 2023
• Completion date: May 2026