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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

Treatment guided by clinical symptoms and signs + NTproBNP

Treatment guided by clinical symptoms and signs

The purpose is to study if HF treatment guided by NTproBNP in addition to clinical symptoms and signs is more effective than treatment guided by clinical symptoms and signs alone in patients with HF and left ventricular systolic dysfunction

Evaluation of heart failure treatment guided by N-terminal pro b-type natriuretic peptide (NTproBNP) vs clinical symptoms and signs alone

Research Site

A randomised, single blind, multicentre, 9-month, phase IV study, comparing treatment guided by clinical symptoms and signs and NT-proBNP vs treatment guided by clinical symptoms and signs alone, in patients with heart failure (HF) and left ventricular systolic dysfunction

The non-parametric scale is constructed from 3 variables, modified after Cleland. Each patient receives a rank score from 1 to 246 (246-number of patients in the study). The lowest score receive patients who die (due to CV event), next patients still alive at end-of-study with the worst composite score, the best alive patients with 0 days in hospital and the largest improvement in the KCCQ (self-administered by patient symptom score, where the higher score reflect better health status). Scores will be summarized using non-parametric calculations. The mean of non-parametric scores is presented

Age Continuous

Gender, Male/Female

Electrocardiogram (ECG), Abnormal/Normal

Study Specific Characteristic

Diastolic blood pressure

Pulse

Systolic blood pressure

In the above analysis regarding The number of participants analyzed the ‘last observation carried forward’ principle is used, as pre-specified in the protocol.

Composite value of 3 variables after 9 months: Cardiovascular death (days alive), Cardiovascular hospitalization (days out of hospital), Heart failure symptoms (symptom score subset of the Kansas City Cardiomyopathy Questionnaire - questions 3,5,7,9)

Number of CV deaths

Each overnight stay is counted as one day. The lower the better

Number of days in hospital for CV reason

Changes from baseline in the symptom score subset (question 3, 5, 7 and 9) of KCCQ (swelling, fatigue, shortness of breath, shortness of breath night time). KCCQ is a self-administered by patient symptom score, where higher score reflect better health status. Scale scores are transformed to a 0 to 100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100. This mean that the KCCQ scale is from 0 to 100 with the higher value showing a better health status.

Changes in heart failure symptoms

The 95% confidential interval (CI) is given as measure of dispersion

Changes in NT-proBNP values over time in all patients

Change range –100 to 100. The higher the better.

Changes in health-related quality of life

Each titration step in prescribed medication is counted as one step, either up or down. One step up indicates an increase of dose in prescribed medication and one step down indicates a decrease of dose in prescribed medication. The sum of steps is given as a score. Score is given for each arm as a total number of titration steps for all patients in arm.

Total Number of Titration steps in Prescribed Heart Failure Treatment

Number of patients discontinued due to adverse events’

Discontinuations

Overall Study

At visit 1 was the NT-proBNP value measured at this value should be above 800 (females) or 1000 (males) before randomisation at visit 2. One patient from each group are excluded from the full analysis set (FAS) due to “total unavailability of efficacy data after randomisation”.

Arms	Assigned Interventions
Other: Guided by NT-proBNP Treatment guided by clinical symptoms and signs + NTproBNP	-
Other: Not Guided by NT-proBNP Treatment guided by clinical symptoms and signs	-

Evaluation of heart failure treatment guided by N-terminal pro b-type natriuretic peptide (NTproBNP) vs clinical symptoms and signs alone

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=304&filename=CSR-D2452L00010.pdf

CSR-D2452L00010.pdf

Contacts

Contact

Investigators

Principal Investigator