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Completed

NCT Number: NCT00391846

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Site, Alvesta, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

captopril

Drug

Enalapril

Drug

Lisinopril

Drug

Ramipril

Drug

trandolapril

Drug

Bisoprolol

Drug

Carvedilol

Drug

Metoprolol succinate

Drug

Candesartan

Drug

Other names: Atacand

valsartan

Drug

Eplerenone

Drug

Spironolactone

Drug

Diuretics

Drug

HF treatment according to Swedish guidelines

Drug

Blood samples

Procedure

The Kansas City Cardiomyopathy Questionnaire (KCCQ)

Procedure

Primary outcomes

  1. 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)

    Time frame: 9 months

    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

Secondary outcomes

  1. Number of CV Deaths

    Time frame: 9 months

    Number of deaths

  2. Number of Days in Hospital for CV Reason

    Time frame: 9 months

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

  3. Changes in Heart Failure Symptoms

    Time frame: 9 months and baseline

    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.

  4. Changes in NT-proBNP Values Over Time in All Patients

    Time frame: 9 months and baseline

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

  5. Changes in Health-related Quality of Life

    Time frame: 9 months and baseline

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

  6. Total Number of Titration Steps in Prescribed Heart Failure Treatment

    Time frame: 9 months

    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.

  7. Discontinuations

    Time frame: 9 months

    Number of patients discontinued due to adverse events'

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Oct 25, 2006
Registry last updated
Jun 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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