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Status unknownNCT03904485AMI-SPKUpdated Apr 5, 2019

Assessment of Myocardial Injury in Simultaneous Pancreas and Kidney Transplantation

An observational study in Simultaneous Pancreas-kidney Transplantation and Diabetic Cardiomyopathy, sponsored by Tianjin First Central Hospital. Status unknown at 1 site in China. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-04-05.

Sponsored by Tianjin First Central Hospital · Observational

The sponsor has not verified this record recently (last verified Apr 2019), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
50
Ages
20 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Simultaneous Pancreas-kidney Transplantation
  • Diabetic Cardiomyopathy

Keywords

  • SPK ,DCM,CMR
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In context

Cardiomyopathies

1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.

This study's planned enrollment of 50 is below the median of 153 across 515 observational studies indexed under Cardiomyopathies.

Browse Cardiomyopathies studies →

Lead sponsor

Tianjin First Central Hospital is the lead sponsor of 18 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

A total of 25 patients with SPK who met the inclusion criteria and 25 patients with simple kidney transplantation for diabetic end-stage nephropathy were included by matching the onset time, gender, age, BMI and blood pressure of diabetes

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

Exclusion Criteria:

  1. Contraindications in cardiac magnetic resonance imaging；2.poorly controlled hypertension；3.CMR examination revealed marked hypertrophy of the left ventricular myocardium
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • SPKT

    patients with end-stage diabetic nephropathy got simultaneous pancreas-kidney transplantation

    Radiation: cardiac magnetic resonance(CMR) T2 mapping

  • RT

    patients with end-stage diabetic nephropathy got single kidney transplantation

    Radiation: cardiac magnetic resonance(CMR) T2 mapping

Interventions

  • Radiationcardiac magnetic resonance(CMR) T2 mapping

    T2 value before transplant，3 month and 6month after transplant

06

What researchers measure

Primary outcomes

  1. Assessment of myocardial injury

    Assessment of myocardial injury between two groups

    Time frame: 1year

07

Study locations

1 site
  • Tianjin First central hospital
    Tianjin, China
08

References and documents

Publications

  • Messroghli DR, Radjenovic A, Kozerke S, Higgins DM, Sivananthan MU, Ridgway JP. Modified Look-Locker inversion recovery (MOLLI) for high-resolution T1 mapping of the heart. Magn Reson Med. 2004 Jul;52(1):141-6. doi: 10.1002/mrm.20110. PubMed 15236377 ↗
  • Ding H, Fernandez-de-Manuel L, Schar M, Schuleri KH, Halperin H, He L, Zviman MM, Beinart R, Herzka DA. Three-dimensional whole-heart T2 mapping at 3T. Magn Reson Med. 2015 Sep;74(3):803-16. doi: 10.1002/mrm.25458. Epub 2014 Sep 19. PubMed 25242141 ↗

Individual participant data

Plan to share: Undecided — Study data including numbers, clinical data, and corresponding CMR results, were shared every three months

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03904485
Lead sponsor
Tianjin First Central Hospital
Responsible party
Yingxin FU.MD (Director of kidney transplantation center, Tianjin First Central Hospital) — Principal investigator
First posted
Apr 5, 2019
Start date
Apr 1, 2019
Primary completion
Apr 1, 2020 (estimated)
Completion
Apr 1, 2021 (estimated)
Last update
Apr 5, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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