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Heart FailurePhase 4NCT00391846

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

A Phase 4 study testing Captopril, Enalapril and Lisinopril in people with Heart Failure and Ventricular Dysfunction, Left, run by AstraZeneca at 39 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure, Ventricular Dysfunction, Left
What is being tested?
Captopril, Enalapril and Lisinopril
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
252 participants
Where
39 sitesSweden
Study dates
Oct 2006to Jan 2009
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

39 sites in 1 country.

39 sites in 1 country

Sweden39 sites

  • Research Site

    Alvesta

  • Research Site

    Arvika

  • Research Site

    Bjuv

  • Research Site

    Borensberg

  • Research Site

    Bromma

  • Research Site

    Dalby

  • Research Site

    Eskilstuna

  • Research Site

    Gagnef

  • Research Site

    Gothenburg

  • Research Site

    Hisings Kärra

  • Research Site

    Huddinge

  • Research Site

    Huskvarna

  • Research Site

    Jönköping

  • Research Site

    Kalmar

  • Research Site

    Kungälv

  • Research Site

    Lerum

  • Research Site

    Lessebo

  • Research Site

    Lidköping

  • Research Site

    Lilla Edet

  • Research Site

    Linköping

  • Research Site

    Ludvika

  • Research Site

    Lyckeby

  • Research Site

    Malmö

  • Research Site

    Moheda

  • Research Site

    Motala

  • Research Site

    Örebro

  • Research Site

    Östersund

  • Research Site

    Skanör

  • Research Site

    Söderåkra

  • Research Site

    Stenungsund

  • Research Site

    Stocksund

  • Research Site

    Timrå

  • Research Site

    Uddevalla

  • Research Site

    Ulricehamn

  • Research Site

    Umeå

  • Research Site

    Uppsala

  • Research Site

    Västerås

  • Research Site

    Västervik

  • Research Site

    Vaxjo

Other trials in Sweden

About this study

Official 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

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

Being tested
Captopril, Enalapril, Lisinopril, Ramipril, Trandolapril
Keywords
Heart Failure, Ventricular Dysfunction, NTproBNP
Medical subject headings
Heart Failure, Ventricular Dysfunction, Left, Ventricular Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CaptoprilDrug

  • EnalaprilDrug

  • LisinoprilDrug

  • RamiprilDrug

  • TrandolaprilDrug

  • BisoprololDrug

  • CarvedilolDrug

  • Metoprolol succinateDrug

  • CandesartanDrug

    Also called Atacand

  • ValsartanDrug

  • EplerenoneDrug

  • SpironolactoneDrug

  • DiureticsDrug

  • HF treatment according to Swedish guidelinesDrug

  • Blood samplesProcedure or surgery

  • The Kansas City Cardiomyopathy Questionnaire (KCCQ)Procedure or surgery

Study groups in NCT00391846
Study groupRoleWhat they receive
Guided by NT-proBNPOtherTreatment guided by clinical symptoms and signs + NTproBNP
Receives: Drug: Captopril; Drug: Enalapril; Drug: Lisinopril; Drug: Ramipril; Drug: Trandolapril; Drug: Bisoprolol; Drug: Carvedilol; Drug: Metoprolol succinate; Drug: Candesartan; Drug: Valsartan; Drug: Eplerenone; Drug: Spironolactone; Drug: Diuretics; Drug: HF treatment according to Swedish guidelines; Procedure: Blood samples; Procedure: The Kansas City Cardiomyopathy Questionnaire (KCCQ)
Not Guided by NT-proBNPOtherTreatment guided by clinical symptoms and signs
Receives: Drug: Captopril; Drug: Enalapril; Drug: Lisinopril; Drug: Ramipril; Drug: Trandolapril; Drug: Bisoprolol; Drug: Carvedilol; Drug: Metoprolol succinate; Drug: Candesartan; Drug: Valsartan; Drug: Eplerenone; Drug: Spironolactone; Drug: Diuretics; Drug: HF treatment according to Swedish guidelines; Procedure: Blood samples; Procedure: The Kansas City Cardiomyopathy Questionnaire (KCCQ)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    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

    Measured: 9 months

Secondary outcomes (7)

  1. Number of CV Deaths

    Number of deaths

    Measured: 9 months

  2. Number of Days in Hospital for CV Reason

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

    Measured: 9 months

  3. 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.

    Measured: 9 months and baseline

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

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

    Measured: 9 months and baseline

  5. Changes in Health-related Quality of Life

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

    Measured: 9 months and baseline

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

    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.

    Measured: 9 months

  7. Discontinuations

    Number of patients discontinued due to adverse events'

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2006 (estimated)
  2. Study startOct 2006
  3. Primary completionJan 2009
  4. Study completionJan 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
252 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00391846
Sponsor's protocol ID
D2452L00010
Other IDs
EUDRACT No. 2006-001259-36, SIGNAL HF
Status last verified
Jun 2012
First submitted
19 Oct 2006
Last updated
25 Jun 2012
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Captopril, Enalapril and Lisinopril in people with Heart Failure and Ventricular Dysfunction, Left, run by AstraZeneca at 39 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00391846.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2012.

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