Evaluation of Heart Failure Treatment Guided by N-terminal Pro B-type Natriuretic Peptide (NTproBNP) vs Clinical Symptoms and Signs Alone

AstraZeneca252 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

252

Conditions

Heart Failure Ventricular Dysfunction, Left

Interventions

CaptoprilDRUG

EnalaprilDRUG

LisinoprilDRUG

RamiprilDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Female/male, over 18 years with previously verified HF with left ventricular systolic dysfunction. * New York Heart Association(NYHA) class II-IV, * NTproBNP males\>800 ng/L, females \>1000 ng/L Exclusion Criteria: * Planned CV hospitalisation, stroke or acute myocardial infarction (MI) last 3 months, * Mitral/aortic stenosis, * Patients already receiving optimal HF treatment, * Severe reduction of kidney function

Locations (39)

Outcomes

Primary Outcomes

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)

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

Time frame: 9 months

Secondary Outcomes

Number of CV Deaths

Number of deaths

Time frame: 9 months

Number of Days in Hospital for CV Reason

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

Time frame: 9 months

Changes in Heart Failure Symptoms

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.

Time frame: 9 months and baseline

Changes in NT-proBNP Values Over Time in All Patients

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

Data from ClinicalTrials.gov

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