Trial document




drksid header

  DRKS00010514

Trial Description

start of 1:1-Block title

Title

Adherence to lipid-lowering therapy after cardiac rehabilitation

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

LLT-R-Registry

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

During inpatient hospital stay for cardiac rehabilitation a medical treatment plan is established to contribute, inter alia, for lowering blood lipid levels. Impaired blood lipid levels are known risk factors for cardiovascular disease. Drug based treatment (for example, lipid-lowering substances = statins) leads to the optimization of lipid metabolism and reduces the likelihood of re-events such as heart attack or stroke. The aim of this study is to verify the compliance with the medical treatment plan prescribed in the medical discharge report and the blood fat levels in the further course. The participantion will not have an influence on the therapy decision. There will be no difference in the course of therapy from that of a non - study participant.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

In the western industrialized nations a large proportion of morbidity and mortality is associated with Coronary heart disease (CHD). The treatment of CHD is based on the the prevention of risk factors such as diabetes, hypertension, smoking and obesity. There is evidence that treatment with platelet inhibitors, ACE inhibitors, beta-blockers and in particular lipid-lowering substances may increase the life expectancy and quality of life of CHD patients. The most important drugs for evidence-based lipid-lowering treatment (LLT) of CHD are statins. The goal of this treatment is to reach a LDL cholesterol value of less than 1.8 mmol/L or, if not achievable, a reduction of 50 %. However, a poor patient compliance is a serious problem in taking lipid-lowering treatment during the therapy of patients with coronary heart disease. The aim of this study is to verify the compliance with the medical treatment plan prescribed in the medical discharge report and the blood fat levels in the further course.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00010514
  •   2016/05/13
  •   2016/04/22
  •   yes
  •   Approved
  •   16/16, Ethik-Kommission der Ärztekammer Sachsen-Anhalt Bezirksstelle Halle
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   NCT02749279   (clinicaltrials.gov)
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Coronary Heart Disease
  •   I20-I25 -  Ischaemic heart diseases
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   After discharge of patients from the rehabilitation questions regarding to the drug treatment will be evaluated during the following 12 months by use of a patient diary. It has to be documented whether the drug plan has changed and if so, why and who (physician, patient) made ​​the change. In addition, questions with particular reference to the lipid-lowering therapy will be collected after 3 and 12 months based on a questionnaire .
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Adherence to the recommended medication plan at discharge derived from the question, whether treatment plan was changed within 12 months since leaving the clinic (yes or no).

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

1. Reason for the changes to the drug plan determined by the question whether the change(s) were made by the physician or by the patient.

2. Reason for the changes to the drug plan determined by the question whether the change(s) to the drug plan was induced by an intolerance to the drug pruduct.

3. Reaching of the treatment goal of lipid -lowering therapy during the rehabilitation stay, as measured by the LDL Cholesterien value (< 1.8 mmol/l = 70 mg/dl)

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2016/05/04
  •   1100
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- Age ≥ 18 years
- Coronary Heard Disease
- lipid-lowering therapy
- inpatient hospital stay in one of the recruiting sites

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

- Lack of informed consent
- Diseases or disorders that may prevent a participation to this study according to the investigators judgement (dementia, psychotic disorders)

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Paracelsus-Harz-KlinikKardiologie, Pneumologie, Diabetes
    • Mr.  Prof. Dr. med.  Axel  Schlitt 
    • Paracelsusstraße 1
    • 06485  Quedlinburg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Martin Luther-Universität Halle-Wittenberg Medizinische Fakultät Koordinierungszentrum für Klinische Studien
    • Mr.  Dr. sc. nat.  Michael  Richter 
    • 06097  Halle (Saale)
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Paracelsus-Harz-KlinikKardiologie, Pneumologie, Diabetes
    • Mr.  Prof. Dr. med.  Axel  Schlitt 
    • Paracelsusstraße 1
    • 06485  Quedlinburg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Paracelsus-Harz-KlinikKardiologie, Pneumologie, Diabetes
    • Mr.  Prof. Dr. med.  Axel  Schlitt 
    • Paracelsusstraße 1
    • 06485  Quedlinburg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Sanofi-Aventis Deutschland GmbH
    • 10785  Berlin
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.