Lipid Lowering Therapy After Cardiac Rehabilitation LLT-R-Registry (LLT-R-Registry)

August 27, 2019 updated by: Paracelsus Harz Clinic Bad Suderode.

Adherence to Lipid Lowering Therapy After Cardiac Rehabilitation (LLT-Rehabilitation-Registry)

The most important drugs for evidence based lipid lowering treatment (LLT) in CHD are statins. All patients with established CHD should be treated with statins irrespective of low density lipoprotein (LDL) cholesterol (LDL-C) levels. The goals of treatment are LDL-C below 1.8 mmol/L (70 mg/dL) or 50% LDL-C reduction when target level cannot be reached. Unfortunately, several patients cannot achieve treatment targets also related to the serious problem of adherence to therapy, which includes also LLT.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

In German rehabilitation clinics the number of patients who has a clear indication for LLT is continuously high since years. Approximately 2,000 patients with cardiac diseases were treated per year per clinic and momentarily approximately three fourth of them have an indication for LLT, mainly patients with CHD. The main length of stay in German rehabilitation clinics is 21 days, which gives the chance and the necessity to optimize LLT, since in approximately 50% of all patients with an indication for LLT treatment targets are not achieved.

After patients will give written informed consent, data will be collected. Here, all relevant baseline parameters (drug treatment, indication for rehabilitation, all clinical diagnoses, age, sex, BMI, echocardiographic parameters such as left ventricular ejection fraction, laboratory parameters corresponding to the recording standard of the clinic, etc.) will be recorded in a central database (online-CRF). Furthermore, as the main topic of interest of the study, LLT at baseline, LLT during the rehabilitation phase, and LLT treatment at discharge including the recommendation given for the home physicians regarding LLT in the discharge letter will be collected. Here, according to the AHA/ACC Guideline (9) LLT will be stratified in low-intensity statin therapy (Simvastatin 10mg, Pravastatin 10-20mg, Lovastatin 20mg, Fluvastatin 20-40mg), moderate-intensity statin therapy (Atorvastatin 10-20mg, Rosuvastatin 5-10mg, Simvastatin 20-40mg, Pravastatin 40-80mg, Lovastatin 40mg, Fluvastatin 80mg) and high-intensity statin therapy (Atorvastatin 40-80mg, Rosuvastatin 20-40mg). Furthermore, data on other lipid lowering drugs such as cholesterol resorption inhibitors, fibrates and PCSK-9 inhibitors will be collected. Adverse events related to drug therapy will be further collected and submitted to the German health authorities. Furthermore, serious adverse events (SAE), for drugs manufactured by Sanofi-Aventis, Zentiva or Genzyme, will be submitted to Sanofi-Aventis.

At discharge patient will receive a questionnaire, which includes questions about change of drug treatment during the next 12 months. Here, patients will record prospectively whether medication has been changed and if so, why, and who changed it.

After discharge patients will be contacted by mail after three and twelve months. Patients will asked in addition to the questionnaire at discharge about drug therapy with special regards to LLT Changes in medication will be documented by comparison of drug list at discharge with the patient reported drugs, which are taken at time of follow-up.

Furthermore, general questions about other drug therapy, re-hospitalizations especially in connection with atherosclerotic diseases such as cardiac death, Re-PCI, Bypass, pulmonary embolism, TIA/ stroke, bleeding, ACS/MI, and others are recorded. In this disease registry these endpoints will be recorded separately and statistically analyzed, however not defined as AE and not recorded as such. Patients will be further asked whether other adverse events occurred and whether they may be related to drug therapy. If AEs in relation to drug therapy will be reported these information will be submitted to the German health authorities. SAE, with drugs manufactured by Sanofi-Aventis,Zentiva or Genzyme will be submitted to Sanofi-Aventis.

Clinical research organization (CRO) will carry out

  • GCP-compliant data management: eCRF - creation including validation and consistency checks, input and training regarding the manual (while auditors meeting), online delivery incl. license allocation and support, patient registration, query management, data export to biometrics.
  • GCP-compliant quality control (Clinical Monitoring), setup process including monitoring, initiating the inspection once centrally (auditors meeting) including a total of 22 on-site visits (2 / center).
  • Study preparation incl. review of study documents, submission to ethics committees, supporting the drafting and implementation, creation of test folder and the "Trial Master Files"
  • Study Coordination and care of the on-site files

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Saxony-Anhalt
      • Quedlinburg, Saxony-Anhalt, Germany, 06485
        • Paracelsus Harz Clinic Bad Suderode

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients with CHD, who will be admitted for cardiac rehabilitation to the participating German rehabilitation clinics and in whom LLT is indicated will be included. Written informed consent will be obtained from each participant. Beginning of the study is 1st May 2016, the inclusion of the last patient is expected on 30th April 2016. Follow-up: at 3 and 12 months, respectively, inclusion of 100 participants per clinic is expected.

Description

Inclusion Criteria:

  • Lipid lowering therapy after cardiac rehabilitation

Exclusion Criteria:

  • Inability or refusal to give written informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Data collection (Adherence to lipid lowering therapy after cardiac rehabilitation)
Time Frame: 12 Months
Adherence to lipid lowering therapy after cardiac rehabilitation
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Paracelsus Harz Clinic Bad Suderode.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
KKS Netzwerk

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 8, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ParacelsusHCBS 01/16

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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