क्लिनिकल ट्रायल रडार

Combined endpoint of rehospitalization (time to first event) and quality of life (QoL)

Combined endpoint of rehospitalization (time to first event) and quality of life (QoL) measured by total points in the validated Kansas City Cardiomyopathy Questionnaire (KCCQ-12) with 0 points meaning badest QoL possible an 100 points best QoL possible. Interpretation of KCCQ-12 total scores: 0-24: Very poor to poor, 25-49: Poor to moderate, 50-74: Moderate to good, 75-100: Good to excellent

12 months

Combined endpoint of rehospitalization (time to first event) and quality of life (QoL)

Combined endpoint of rehospitalization (time to first event) and quality of life (QoL) measured by total points in the validated Kansas City Cardiomyopathy Questionnaire (KCCQ-12) with 0 points meaning badest QoL possible an 100 points best QoL possible. Interpretation of KCCQ-12 total scores: 0-24: Very poor to poor, 25-49: Poor to moderate, 50-74: Moderate to good, 75-100: Good to excellent

24 months

all-cause mortality

all-cause mortality, defined as number of deaths of any cause that occur during the course of study

24 months

cardiovascular mortality

cardiovascular mortality, defined as number of deaths of cardiovascular cause that occur during the course of study, in particular death due to heart failure, myocardial infarction, stroke, sudden cardiac death

24 months

completeness of anticongestive medication

completeness of anticongestive medication, defined as use (0 = no, 1 = yes) of the four drug groups for heart failure (1. Angiotensin-converting enzyme inhibitor or angiotensin-1 receptor antagonist or angiotensin-1 receptor antagonist in combination with neprylisin inhibitor, 2. Beta blocker, 3. mineralocorticoid receptor antagonist, 4. Sodium-glucose-linked transporter 2 inhibitor) on a scale of 0 to 4 (0 = no substance group is taken, 1 = one substance group is taken, 2 = two substance groups are taken, 3 = three substance groups are taken, 4 = four substance groups are taken)

24 months

changes in ejection fraction

changes in ejection fraction, defined as delta in the percentage of left-ventricular ejection fraction measured at randomisation, after 12 month and after 24 months (delta %)

24 months

NTproBNP

defined as delta in NTproBNP (N-terminal pro-brain natriuretic peptide)-levels measured in nanogram per litre (ng/l) between hospitalisation, 12 months and 24 months

24 months

ferritin and transferrin levels

defined as delta in ferritin-levels measured in microgram per litre (ug/l) and transferrin-levels measured in gram per litre (g/l) between hospitalisation, 12 months and 24 months

24 months

6-minute walking distance

defined as delta in the distance (measured in meters) a patient can walk in a standardised 6-minute walking distance between hospitalisation, 12 months and 24 months

24 months

relative maximum oxygen-consumption (peak VO2)

defined als delta in the relative maximum oxygen-consumption (peak VO2, ml/min/kg) measured by standardised cardiopulmonary exercise test between hospitalisation, 12 months and 24 months

24 months

NYHA class

defined as delta in the New-York-Heart-Association (NYHA) class between randomisation, 12 months and 24 months, whereby NYHA-class is defined on a scale from 1 to 4: 1 (no limitation): Normal physical exertion causes no symptoms, 2 (mild limitation): No symptoms at rest, but symptoms occur during normal, more strenuous exertion (e.g., climbing stairs, 3 (significant limitation): No symptoms at rest, but symptoms occur even with light physical exertion (e.g., walking on level ground), 4 (severe limitation): Symptoms occur even at rest, bedridden possible.

24 months

quality of life (points in KCCQ-12)

quality of life (QoL) measured by total points in the validated Kansas City Cardiomyopathy Questionnaire (KCCQ-12) with 0 points meaning badest QoL possible an 100 points best QoL possible. Interpretation of KCCQ-12 total scores: 0-24: Very poor to poor, 25-49: Poor to moderate, 50-74: Moderate to good, 75-100: Good to excellent

24 months

depression status (points in PHQ-9)

defined as delta in the total score in the standardised PHQ-9-questionnaire that indicates the severity of depressive symptoms between hospitalisation, 12 months and 24 months. The total score ranges from 0 to 27 points. Higher scores correspond to more severe symptoms: 0-4: No to minimal symptoms, 5-9: Mild depression, 10-14: Moderate depression. 15-19: Severe depression. 20-27: Severe depression

24 months

score for self-care in dealing with heart failure (EHFScBS)

defined as delta in the total score in the standardised EHFScBS-questionnaire to measure the self-care behavior of patients with heart failure between hospitalisation, 12 months and 24 months. The questionnaire consists of 9 questions for self-care in dealing with heart failure that are answered on a Likert scale from 1 ("I completely agree") to 5 ("I completely disagree"). The sum of the 9 items results in a score between 9 and 45 points. A lower raw score indicates better self-care behavior (fewer problems in everyday life), while a higher raw score indicates poorer self-care behavior and greater deficits. The delta of total points between hospitalisation, 12 months and 24 months is measured.

24 months

number of correct answers in the AHFKT questionnaire

defined as delta in the number of correct answers in the Atlanta Heart Failure Knowledge Test (AHFKT) questionnaire between hospitalisation, 12 months and 24 months. The Atlanta Heart Failure Knowledge Test is a valid tool for measuring patients' knowledge about their own chronic heart failure. It contains of 30 questions with the option of answering either yes or no or selecting one of four possible answers, with only one answer being correct in each case. 0 points indicates the worst/no knowledge of heart failure, while 30 points indicates the best knowledge of heart failure.

24 months