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Coronary Artery Disease After Heart Transplantation (ECP)

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ClinicalTrials.gov Identifier: NCT03583229
Recruitment Status : Recruiting
First Posted : July 11, 2018
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
Hans Eiskjær, Aarhus University Hospital

Brief Summary:
This study evaluates coronary artery disease after heart transplantation and its relation to platelet function. Furthermore, we will evaluate extracorporeal photopheresis as treatment of coronary artery disease after heart transplantation.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease in Transplanted Heart (Diagnosis) Platelet Dysfunction Drug: Aspirin 75mg Other: Extracorporeal photopheresis Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ECP Study: Extracorporeal Photopheresis as Treatment of Cardiac Allograft Vasculopathy After Heart Transplantation and Evaluation of Platelet Function and Aggregation After Heart Transplantation
Actual Study Start Date : October 13, 2016
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Aspirin - single arm
1 tablet of Aspirin 75 mg administered x 1 daily for 7 days.
Drug: Aspirin 75mg
7 days treatment with 75 mg aspirin daily.

Experimental: Extracorporeal photopheresis
All patients with HLA antibodies receive 4 ECP-treatments in 2 months.
Drug: Aspirin 75mg
7 days treatment with 75 mg aspirin daily.

Other: Extracorporeal photopheresis
4 x ECP treatments in 60 days.

No Intervention: Control group
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.



Primary Outcome Measures :
  1. Changes in CAV [ Time Frame: Baseline and 12 months follow up ]
    Changes in CAV assessed by CAG, OCT and advanced echocardiography


Secondary Outcome Measures :
  1. Platelet aggregation assessment related to CAV. [ Time Frame: Baseline and 7 days after aspirin treatment. ]
    Platelet aggregation compared to healthy controls and patients with coronary artery disease.

  2. Changes in platelet aggregation [ Time Frame: Baseline and 7 days after aspirin treatment. ]
    Changes in platelet aggregation before and after aspirin

  3. Changes in DSA levels [ Time Frame: Baseline and 12 months follow up ]
    Changes in DSA levels before and after ECP-treatment

  4. Changes in exercise and longitudinal myocardial deformation capacity [ Time Frame: Baseline and 12 months follow up ]
    changes in exercise and longitudinal myocardial deformation capacity before and after ECP treatment.

  5. Changes in CFVR [ Time Frame: Baseline and 12 months follow up ]
    Changes in microvascular function assessed by CFVR before and after ECP treatment.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-100
  • Informed and signed consent
  • Positive Luminex analysis: Blood samples with DSA levels >3000 MFI
  • Coronary angiography with evidence of CAV (ISHLT class ≥1) according to ISHLT criteria's.

Exclusion Criteria:

  • Severe asthma or COLD with FEV1 < 50%*
  • 2° or 3° AV block*
  • Pregnancy
  • Creatinine >250 mmol/l**
  • Platelet count below 20 x 109/L
  • History of allergy to 8-Methoxypsoralen (8-MOP)
  • History of light-sensitive disease

    • These patients will not be subjected to adenosine submission **These patients will not be subjected to OCT evaluation

Control groups:

  • 120 patients with angiographically proven coronary artery disease treated with 75 mg aspirin daily for at least seven days (no other antithrombotic drugs are allowed). These data is already available.
  • 60 healthy subjects on no medication - samples are taken before and after 75 mg aspirin daily for at least seven days. These data is already available.

As the data regarding the control groups are already available from previous studies at our department, these control patients are no considered actively included in this study. Hence, the patient population consists of the 60 HTx patients.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03583229


Contacts
Contact: Kamilla Pernille Bjerre, MD 0045 53535832 kambje@rm.dk
Contact: Hans Eiskjær, Professor 0045 30922347 hanseisk@rm.dk

Locations
Denmark
Aarhus Universitetshospital, Afdeling for Hjertesygdomme Recruiting
Aarhus N, Denmark, 8200
Contact: Kamilla Pernille Bjerre, MD    0045 53535832    kambje@rm.dk   
Contact: Hans Eiskjær, Professor    0045 30922347    hanseisk@rm.dk   
Principal Investigator: Hans Eiskjær, Professor         
Sub-Investigator: Kamilla Pernille Bjerre, MD         
Sub-Investigator: Tor Skibsted Clemmensen, MD, PhD         
Sponsors and Collaborators
Aarhus University Hospital
Investigators
Principal Investigator: Hans Eiskjær, Professor Aarhus Universitetshospital, Afdeling for Hjertesygdomme, Palle Juul Jensens Blvd. 99, 8200 Aarhus N

Publications:

Responsible Party: Hans Eiskjær, Professor, DMSc, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT03583229     History of Changes
Other Study ID Numbers: ECP studiet
First Posted: July 11, 2018    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Hans Eiskjær, Aarhus University Hospital:
Heart Transplantation
Cardiac Allograft Vasculopathy

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics