1 tablet of Aspirin 75 mg administered x 1 daily for 7 days.

All patients with HLA antibodies receive 4 ECP-treatments in 2 months.

The control group does not receive ECP-treatments, but blood samples are drawn at the same intervals as treatment group and CAG+OCT are also performed at baseline and 12 months follow up as the treatment group.

Coronary Artery Disease in Transplanted Heart (Diagnosis)

Platelet Dysfunction

7 days treatment with 75 mg aspirin daily.

Aspirin 75mg

Extracorporeal photopheresis

Aarhus Universitetshospital, Afdeling for Hjertesygdomme

Coronary Artery Disease After Heart Transplantation

ECP Study: Extracorporeal Photopheresis as Treatment of Cardiac Allograft Vasculopathy After Heart Transplantation and Evaluation of Platelet Function and Aggregation After Heart Transplantation

Changes in CAV assessed by CAG, OCT and advanced echocardiography

Platelet aggregation compared to healthy controls and patients with coronary artery disease.

Changes in platelet aggregation before and after aspirin

Changes in DSA levels before and after ECP-treatment

changes in exercise and longitudinal myocardial deformation capacity before and after ECP treatment.

Changes in microvascular function assessed by CFVR before and after ECP treatment.

Hans Eiskjær

Professor, DMSc

Aarhus University Hospital

Patients with antibodies receive 4 ECP-treatments if they have CAV. If patients do not want to receive ECP-treatments, they are allocated to the control group, which do not receive ECP-treatments.
All patients receive 7 days treatment with aspirin and blood samples are drawn before and after.

Eleven participants will be vitamin D deficient with LDL-C between 100 to 130mg/dl.
This arm will receive Simvastatin 40 mg once daily and placebo once weekly, and will perform moderate intensity exercise for twelve weeks. Participants will be advised to walk a minimum of 3000 steps in 30 minutes on 5 days each week

Eleven participants will be vitaminD deficient with LDL-C between 100 to 130mg/dl.
This arm will receive simvastatin 40 mg once daily and vitaminD 60,000 units once weekly , and will perform moderate intensity exercise for twelve weeks. Participants will be advised to walk a minimum of 3000 steps in 30 minutes on 5 days each week

Eleven participants will be vitamin D deficient with LDL-C between 100 to 130mg/dl This arm will receive vitamin D 60,000 units once weekly and placebo once daily, and will perform moderate intensity exercise for twelve weeks. Participants will be advised to walk a minimum of 3000 steps in 30 minutes on 5 days each week

Participants took simvastatin 40 mg once daily and performed exercise for 12 weeks

Simvastatin and Placebo

Participants took simvastatin 40 mg once daily and vitamin D 60,000 units once weekly, and performed exercise for 12 weeks

Simvastatin and Vitamin D

Participants took vitamin D 60000 units once weekly and performed exercise for 12 weeks

Vitamin D and Placebo

Total

Sex: Female, Male

Race/Ethnicity, Customized

Region of Enrollment

Body mass index(BMI)

HbA1c

Fasting plasma Insulin

Low density Cholesterol (LDL-C)

Peak oxygen consumption (VO2peak) is defined as highest rate at which oxygen can be taken up and utilized by body during severe exercise during bicycle ergometry The participants were encouraged to exercise to exhaustion with progressive 2-minutes increments in the power output during the test. VO2peak was obtained when participants reached volitional exhaustion and met one of the following criteria: plateau in oxygen consumption despite increase in workload, rating of perceived exertion >18, Respiratory exchange ratio > 1.10 and peak heart rate within 10 beats of age predicted maximum.

Peak oxygen consumption(VO2peak)

As VO2peak (expressed as liters of oxygen consumed per minute) is also dependent on age, sex, and body size, it was also expressed as percentage of the predicted value(VO2peak%).

Peak oxygen consumption percentage of predicted value (VO2peak%)

Skeletal muscle citrate synthase activity is a validated marker of mitochondrial content.Skeletal muscle biopsy is obtained from vastus lateralis muscle of five patients in either groups before and after the intervention. Under aseptic conditions, samples were taken in protease inhibitor cocktail and stored at -80ºcelsius. Mitochondrial citrate synthase activity (the working range of the kit was 1.56-100 µg/mL, with intra and inter assay coefficient of variation (CV) of 4.35-6.55 % and 8.3 % respectively) is measured using ELISA Kit (Abcam, Cambridge, UK) as per manufacturer's instructions.

Skeletal muscle citrate synthase activity

Peak oxygen consumption( VO2peak) is defined as the highest rate at which oxygen can be taken up and utilized by the body during severe exercise. The participants were encouraged to exercise to exhaustion with progressive 2-minutes increments in the power output during the test. VO2peak was obtained when participants reached volitional exhaustion and met at least one of the following criteria: plateau in oxygen consumption despite increase in workload, rating of perceived exertion >18, Respiratory exchange ratio > 1.10 and peak heart rate within 10 beats of age predicted maximum. . As VO2peak (expressed as liters of oxygen consumed per minute) is also dependent on age, sex, and body size, it was expressed as percentage of the predicted value(VO2peak%).

Participants received simvastatin 40 mg once daily and performed exercise for 12 weeks

Participants received simvastatin 40 mg once daily and vitamin D 60,000 units once weekly, and performed exercise for 12 weeks

Participants received vitamin D 60,000 units once weekly and performed exercise for 12 weeks

Peak Oxygen Consumption

Skeletal muscle citrate synthase activity is a validated marker of mitochondrial content. Skeletal muscle biopsy was obtained from vastus lateralis muscle of five patients in either groups before and after the intervention. Under aseptic conditions, samples were taken in protease inhibitor cocktail and stored at -80ºC. Mitochondrial citrate synthase activity (the working range of the kit was 1.56-100 µg/mL, with intra and inter assay CV of 4.35-6.55 % and 8.3 % respectively) was measured using ELISA Kit (Abcam, Cambridge, UK) as per manufacturer's instructions.Skeletal muscle citrate synthase activity is a validated marker of mitochondrial content.

Skeletal Muscle Mitochondrial Content

Eleven participants will be vitamin D deficient with LDL-C between 100 to 130mg/dl This arm will receive simvastatin 40 mg once daily and placebo once weekly , and will exercise for twelve weeks

Eleven participants will be vitamin D deficient with LDL-C between 100 to 130mg/dl This arm will receive Simvastatin 40 mg once daily and vitamin D 60000 units once weekly, and will exercise for twelve weeks

Eleven participants will be vitamin D deficient with LDL-C between 100 to 130mg/dl This arm will receive vitamin D 60,000 units once weekly and placebo once daily, and will exercise for twelve weeks

Overall Study

Anil Bhansali

Eleven participants will be vitaminD deficient with LDL-C between 100 to 130mg/dl This arm will receive Simvastatin 40 mg once daily and placebo once weekly, and will exercise for twelve weeks
Simvastatin: Simvastatin in a dose of 40 mg will be provided to the study participants
Placebo: Placebo will be provided to the study participants

Eleven participants will be vitamin D deficient with LDL-C between 100 to 130mg/dl This arm will receive simvastatin 40 mg once daily and vitamin D 60,000 units once weekly , and will exercise for twelve weeks
Vitamin D: Vitamin D will be given to achieve normal serum levels
Simvastatin: Simvastatin in a dose of 40 mg will be provided to the study participants

Eleven participants will be vitamin D deficient with LDL-C between 100 to 130mg/dl This arm will receive vitamin D 60,000 units once weekly and placebo once daily, and will exercise for twelve weeks
Vitamin D: Vitamin D will be given to achieve normal serum levels
Placebo: Placebo will be provided to the study participants

Dyslipidemias

Vitamin D will be given to achieve normal serum levels

Vitamin D

Simvastatin in a dose of 40 mg will be provided to the study participants

Simvastatin

Placebo will be provided to the study participants

adenosine diphosphate/atrophy

Coronary Artery Disease After Heart Transplantation

Effect of Vitamin D Supplementation on Exercise Adaptations in Patients on Statin Therapy

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