Trial · NCT00391846
Evaluation of Heart Failure Treatment Guided by N-terminal Pro B-type Natriuretic Peptide (NTproBNP) vs Clinical Symptoms and Signs Alone
NCT00391846, Phase 4, Completed, AstraZeneca; results first posted 2012-06-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluation of Heart Failure Treatment Guided by N-terminal Pro B-type Natriuretic Peptide (NTproBNP) vs Clinical Symptoms and Signs Alone. Trials, record NCT00391846. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00391846
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Heart Failure Treatment Guided by N-terminal Pro B-type Natriuretic Peptide (NTproBNP) vs Clinical Symptoms and Signs Alone
- NCT number
- NCT00391846
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 252 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Heart Failure, Ventricular Dysfunction, Left
- Interventions
Captopril, Enalapril, Lisinopril, Ramipril, Trandolapril, Bisoprolol, Carvedilol, Metoprolol succinate, Candesartan, Valsartan, Eplerenone, Spironolactone, Diuretics, HF treatment according to Swedish guidelines, Blood samples, The Kansas City Cardiomyopathy Questionnaire (KCCQ)
- First posted
- 2006-10-25
- Last updated
- 2012-06-25
- Other registries' IDs
- eudract:2006-001259-36
- Results first posted
- 2012-06-18
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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) | 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 | Number of CV Deaths | 9 months | Number of deaths |
| Secondary | Number of Days in Hospital for CV Reason | 9 months | Each overnight stay is counted as one day. The lower the better |
| Secondary | Changes in Heart Failure Symptoms | 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. |
| Secondary | Changes in NT-proBNP Values Over Time in All Patients | 9 months and baseline | The 95% confidential interval (CI) is given as measure of dispersion |
| Secondary | Changes in Health-related Quality of Life | 9 months and baseline | Change range -100 to 100. The higher the better. |
| Secondary | Total Number of Titration Steps in Prescribed Heart Failure Treatment | 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. |
| Secondary | Discontinuations | 9 months | Number of patients discontinued due to adverse events' |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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) | 9 months | In the above analysis regarding The number of participants analyzed the 'last observation carried forward' principle is used, as pre-specified in the protocol. | Scores on a scale | MEAN |
| SECONDARY | Number of CV Deaths | 9 months | In the above analysis regarding The number of participants analyzed the 'last observation carried forward' principle is used, as pre-specified in the protocol. | Participants | NUMBER |
| SECONDARY | Number of Days in Hospital for CV Reason | 9 months | In the above analysis regarding The number of participants analyzed the 'last observation carried forward' principle is used, as pre-specified in the protocol. | Days in hospital | MEAN |
| SECONDARY | Changes in Heart Failure Symptoms | 9 months and baseline | In the above analysis regarding The number of participants analyzed the 'last observation carried forward' principle is used, as pre-specified in the protocol. | Categorial scale | MEAN |
| SECONDARY | Changes in NT-proBNP Values Over Time in All Patients | 9 months and baseline | In the above analysis regarding The number of participants analyzed the 'last observation carried forward' principle is used, as pre-specified in the protocol. | ng/L | GEOMETRIC_MEAN |
| SECONDARY | Changes in Health-related Quality of Life | 9 months and baseline | In the above analysis regarding The number of participants analyzed the 'last observation carried forward' principle is used, as pre-specified in the protocol. | KCCQ overall score | MEAN |
| SECONDARY | Total Number of Titration Steps in Prescribed Heart Failure Treatment | 9 months | In the above analysis regarding The number of participants analyzed the 'last observation carried forward' principle is used, as pre-specified in the protocol. | Titration steps | NUMBER |
| SECONDARY | Discontinuations | 9 months | In the above analysis regarding The number of participants analyzed the 'last observation carried forward' principle is used, as pre-specified in the protocol. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
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) | Guided by NT-proBNP | 118.6 | Standard Deviation 558 | Scores on a scale | |
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) | Not Guided by NT-proBNP | 128.4 | Standard Deviation 558 | Scores on a scale | |
| Number of CV Deaths | Guided by NT-proBNP | 4 | Participants | ||
| Number of CV Deaths | Not Guided by NT-proBNP | 5 | Participants | ||
| Number of Days in Hospital for CV Reason | Guided by NT-proBNP | 5.79 | Standard Deviation 6.63 | Days in hospital | |
| Number of Days in Hospital for CV Reason | Not Guided by NT-proBNP | 5.94 | Standard Deviation 6.32 | Days in hospital | |
| Changes in Heart Failure Symptoms | Guided by NT-proBNP | 3.67 | Standard Deviation 20.02 | Categorial scale | |
| Changes in Heart Failure Symptoms | Not Guided by NT-proBNP | 6.11 | Standard Deviation 21.00 | Categorial scale | |
| Changes in NT-proBNP Values Over Time in All Patients | Guided by NT-proBNP | 2332.1 | 95% Confidence Interval 1986.1 to 2738.4 | ng/L | |
| Changes in NT-proBNP Values Over Time in All Patients | Not Guided by NT-proBNP | 2063 | 95% Confidence Interval 1743.2 to 2442.7 | ng/L |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Guided by NT-proBNP | 127 | |
| Overall Study | STARTED | Not Guided by NT-proBNP | 125 | |
| Overall Study | COMPLETED | Guided by NT-proBNP | 119 | |
| Overall Study | COMPLETED | Not Guided by NT-proBNP | 118 | |
| Overall Study | NOT COMPLETED | Guided by NT-proBNP | 8 | |
| Overall Study | NOT COMPLETED | Not Guided by NT-proBNP | 7 |
Source ClinicalTrials.gov
Adverse events160
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Acute Myocardial Infarction | Cardiac disorders | Guided by NT-proBNP | 0 | 127 | |
| serious | Acute Myocardial Infarction | Cardiac disorders | Not Guided by NT-proBNP | 1 | 125 | |
| serious | Anaemia | Blood and lymphatic system disorders | Guided by NT-proBNP | 2 | 127 | |
| serious | Anaemia | Blood and lymphatic system disorders | Not Guided by NT-proBNP | 2 | 125 | |
| serious | Angina Pectoris | Cardiac disorders | Guided by NT-proBNP | 2 | 127 | |
| serious | Angina Pectoris | Cardiac disorders | Not Guided by NT-proBNP | 1 | 125 | |
| serious | Angina Unstable | Cardiac disorders | Guided by NT-proBNP | 1 | 127 | |
| serious | Angina Unstable | Cardiac disorders | Not Guided by NT-proBNP | 0 | 125 | |
| serious | Aortic Aneurysm | Vascular disorders | Guided by NT-proBNP | 0 | 127 | |
| serious | Aortic Aneurysm | Vascular disorders | Not Guided by NT-proBNP | 2 | 125 |
1 to 10 of 160Source ClinicalTrials.gov
See all 160 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Guided by NT-proBNP | ||
| Total, all-cause mortality | Not Guided by NT-proBNP | ||
| Total, other adverse events | Guided by NT-proBNP | 0 | 127 |
| Total, other adverse events | Not Guided by NT-proBNP | 0 | 125 |
| Total, serious adverse events | Guided by NT-proBNP | 46 | 127 |
| Total, serious adverse events | Not Guided by NT-proBNP | 41 | 125 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Guided by NT-proBNP vs Not Guided by NT-proBNP: Discontinuations | Trial comparisons |
| Guided by NT-proBNP vs Not Guided by NT-proBNP: Number of CV Deaths | Trial comparisons |
| Guided by NT-proBNP vs Not Guided by NT-proBNP: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00391846
GET https://conductscience.org/api/trials/v1/NCT00391846/events?page=2