Trial document
DRKS00010514
Trial Description
Title
Adherence to lipid-lowering therapy after cardiac rehabilitation
Trial Acronym
LLT-R-Registry
URL of the Trial
[---]*
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.
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.
Organizational Data
- DRKS00010514
- 2016/05/13
- 2016/04/22
- yes
- Approved
- 16/16, Ethik-Kommission der Ärztekammer Sachsen-Anhalt Bezirksstelle Halle
Secondary IDs
- NCT02749279 (clinicaltrials.gov)
Health Condition or Problem studied
- Coronary Heart Disease
- I20-I25 - Ischaemic heart diseases
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 .
Characteristics
- Non-interventional
- Observational study
- Single arm study
- Open (masking not used)
- [---]*
- Uncontrolled/Single arm
- Prognosis
- Single (group)
- N/A
- N/A
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).
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)
Countries of Recruitment
- Germany
Locations of Recruitment
- Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
Recruitment
- Actual
- 2016/05/04
- 1100
- Multicenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- no maximum age
Additional Inclusion Criteria
- Age ≥ 18 years
- Coronary Heard Disease
- lipid-lowering therapy
- inpatient hospital stay in one of the recruiting sites
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)
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-sponsorstart 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 otherstart of 1:1-Block address contact other- 0345-5574907
- 0345-5575210
- richter.michael at kks-halle.de
- http://www.kks-halle.de
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-contactstart of 1:1-Block address contact scientific-contact- 0394 8599900
- 0394 8599812
- prof.dr.axel.schlitt at paracelsus-kliniken.de
- [---]*
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-contactstart of 1:1-Block address contact public-contact- 0394 8599900
- 0394 8599812
- prof.dr.axel.schlitt at paracelsus-kliniken.de
- [---]*
end of 1:1-Block address contact public-contact
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 materialSupportstart of 1:1-Block address contact materialSupport- [---]*
- [---]*
- [---]*
- [---]*
end of 1:1-Block address contact materialSupport
Status
- Recruiting complete, follow-up continuing
- [---]*
Trial Publications, Results and other Documents
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