Assessment of Myocardial Injury in Simultaneous Pancreas and Kidney Transplantation

• Conditions: Diabetic Cardiomyopathy; Simultaneous Pancreas-kidney Transplantation
• Interventions: Radiation: cardiac magnetic resonance(CMR) T2 mapping

• Registration Number: NCT03904485
• Lead Sponsor: Tianjin First Central Hospital

Brief Summary

Diabetic cardiomyopathy( DCM) is a major complication of diabetes and is a common cardiovascular complication independent of coronary artery disease and hypertension．Trial to assess of myocardial injury in recipients of simultaneous pancreas and kidney transplantation by nuclear magnetic T２ mapping technology.

Detailed Description

1. Evaluate the changes of myocardial injury before and after SPK by cardiac magnetic resonance imaging (CMR),

2. Evaluate the value of SPK in the repair of myocardial injury by comparing with the single renal transplant in recipients with diabetic nephropathy.

Study Timeline

• Status Verified: 2019-04
• Study Start: 2019-04-01
• Study First Submitted: 2019-04-04
• Study First Submitted QC: 2019-04-04
• Last Update Submitted: 2019-04-04
• Study First Posted: 2019-04-05
• Last Update Posted: 2019-04-05
• Primary Completion: 2020-04-01
• Study Completion: 2021-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. patients with type 2 diabetes were treated with SPK; 2.No definite history of cardiovascular diseases (such as congenital heart disease, coronary heart disease, cardiomyopathy or valvular heart disease, etc.); 3. Preoperative hemodialysis 4. No history of heart failure

Exclusion Criteria

1. Contraindications in cardiac magnetic resonance imaging；2.poorly controlled hypertension；3.CMR examination revealed marked hypertrophy of the left ventricular myocardium

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SPKT	cardiac magnetic resonance(CMR) T2 mapping	patients with end-stage diabetic nephropathy got simultaneous pancreas-kidney transplantation
RT	cardiac magnetic resonance(CMR) T2 mapping	patients with end-stage diabetic nephropathy got single kidney transplantation

Primary Outcome Measures

Name	Time	Method
Assessment of myocardial injury	1year	Assessment of myocardial injury between two groups

Trial Locations

Locations (1)

Tianjin First central hospital; 🇨🇳 Tianjin, China