Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2025-12-24 @ 4:34 PM
NCT ID:
NCT01759966
Eligibility Criteria:
Inclusion Criteria HTRs:
* Completed heart transplantation during the last 7-12 weeks
* Age \> 16 years and \< 70 years
Exclusion criteria HTRs:
* Peri- or postoperative complications causing permanent dysfunction of the allograft (such as hyperacute rejection episodes, severe myocardial ischemia, etc.)
* Diabetes with HbA1C \> 6,5 % and/or manifest diabetic complications
* Renal failure with plasma creatinine \> 200 µmol/L
* ECG abnormalities (scattered ectopic beats ad minor conduction problems are allowed)
* Permanently bed-ridden
Inclusion criteria healthy controls:
\- Age and gender matching the HTRs
Exclusion criteria healthy controls:
* Another chronic disease (such as diabetes mellitus)
* Permanent use of pharmaceuticals (including hormone drugs)
* Pregnancy
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
17 Years
Maximum Age:
69 Years
Study:
NCT01759966
Study Brief:
Protocol Section:
NCT01759966