Adherence to Drug Therapy in Patients With HFrEF During Inpatient Rehabilitation and After at 3 and 6-months.
Adherence to Drug Therapy in Patients With HFrEF During Inpatient Rehabilitation and After at 3 and 6-months.
In German cardiac rehabilitation clinics the number of patients with reduced ejection
 fraction is continuously increasing since years. Approximately 2,000 patients with cardiac
 diseases were treated per year per clinic and LVEF < 40% was often found in patients.

 The mean length of stay in the rehabilitation clinics is 21 days, which gives the chance and
 the necessity to optimize not only medical therapy.

 Here, all relevant baseline parameters (indication for rehabilitation, all clinical
 diagnoses, age, sex, BMI, echocardiographic parameters such as LVEF or diastolic dysfunction,
 laboratory parameters corresponding to the recording standard of the clinic, etc.) will be
 recorded in an electronic CRF. Medical treatment is recorded at the drug class level and
 enquires about the use of the following drug classes: betablockers (BB) (yes/no), angiotensin
 converting enzyme inhibitors (ACEI) (yes/no), angiotensin receptor blockers (ARB) (yes/no),
 aldosterone receptor antagonist (yes/no) and diuretics (yes/no). Furthermore, treatment
 according Guideline ESC 2016 (yes/no) will be recorded in all patients at initial
 presentation and follow-up as well as if recommended target dose was reached (yes/no). New
 York Heart Association (NYHA) quantification of heart failure symptoms will be noted.

 Furthermore, NT-proBNP at baseline and, if available, at discharge, Quality of Life (SF-12),
 anxiety and depression (HADS-D) will be determined and non-drug therapy including nutrition
 (minimal nutrition assessment = MNA) (5) and exercise (patient exercise diary) will be
 investigated during inpatient rehabilitation and follow-up period.

 After discharge, patients will be contacted by mail after three and twelve months. Here,
 general questions about drug therapy and dosages, re-hospitalizations especially in
 connection with HFrEF are recorded in a standardized questionnaire. If postal response cannot
 be achieved, a telephone contact will be carried out. Drug therapy with special regards to
 HFrEF will be documented by comparing drug lists at demission to the patient reported drugs,
 which are taken at time of follow-up. The patient will be asked whether medication has been
 changed and if so, why, and who changed it.

 The observational design of the project allows no exact calculation of sample size, however,
 inclusion of 500 patients is aimed (50 patients per site).

 Continuous variables will be described using summary statistics: mean, standard deviation,
 median, 25% and 75% percentiles, and minimum and maximum values. Categorical variables will
 be described using number and percent per category.

 For comparison of change from clinic entry endpoints, which are normally distributed
 variables, the paired sample t-test will be used. The Wilcoxon signed rank test will be used
 to assess skewed change variables, which do not meet the normality assumption. For
 categorical variables, the chi-square test will be employed. Statistical analyses were
 performed using SPSS® software, V24 (SPSS Inc., Chicago, Illinois).
In German cardiac rehabilitation clinics the number of patients with reduced ejection
 fraction is continuously increasing since years. Approximately 2,000 patients with cardiac
 diseases were treated per year per clinic and LVEF < 40% was often found in patients.

 The mean length of stay in the rehabilitation clinics is 21 days, which gives the chance and
 the necessity to optimize not only medical therapy.

 Here, all relevant baseline parameters (indication for rehabilitation, all clinical
 diagnoses, age, sex, BMI, echocardiographic parameters such as LVEF or diastolic dysfunction,
 laboratory parameters corresponding to the recording standard of the clinic, etc.) will be
 recorded in an electronic CRF. Medical treatment is recorded at the drug class level and
 enquires about the use of the following drug classes: betablockers (BB) (yes/no), angiotensin
 converting enzyme inhibitors (ACEI) (yes/no), angiotensin receptor blockers (ARB) (yes/no),
 aldosterone receptor antagonist (yes/no) and diuretics (yes/no). Furthermore, treatment
 according Guideline ESC 2016 (yes/no) will be recorded in all patients at initial
 presentation and follow-up as well as if recommended target dose was reached (yes/no). New
 York Heart Association (NYHA) quantification of heart failure symptoms will be noted.

 Furthermore, NT-proBNP at baseline and, if available, at discharge, Quality of Life (SF-12),
 anxiety and depression (HADS-D) will be determined and non-drug therapy including nutrition
 (minimal nutrition assessment = MNA) (5) and exercise (patient exercise diary) will be
 investigated during inpatient rehabilitation and follow-up period.

 After discharge, patients will be contacted by mail after three and twelve months. Here,
 general questions about drug therapy and dosages, re-hospitalizations especially in
 connection with HFrEF are recorded in a standardized questionnaire. If postal response cannot
 be achieved, a telephone contact will be carried out. Drug therapy with special regards to
 HFrEF will be documented by comparing drug lists at demission to the patient reported drugs,
 which are taken at time of follow-up. The patient will be asked whether medication has been
 changed and if so, why, and who changed it.

 The observational design of the project allows no exact calculation of sample size, however,
 inclusion of 500 patients is aimed (50 patients per site).

 Continuous variables will be described using summary statistics: mean, standard deviation,
 median, 25% and 75% percentiles, and minimum and maximum values. Categorical variables will
 be described using number and percent per category.

 For comparison of change from clinic entry endpoints, which are normally distributed
 variables, the paired sample t-test will be used. The Wilcoxon signed rank test will be used
 to assess skewed change variables, which do not meet the normality assumption. For
 categorical variables, the chi-square test will be employed. Statistical analyses were
 performed using SPSS® software, V24 (SPSS Inc., Chicago, Illinois).
Inclusion Criteria:

 -  patients with HFrEF

 Exclusion Criteria:

 -  Inability or refusal to give written informed consent