Heart Failure, CongestiveNCT00149422
Effect of NT-proBNP Guided Treatment of Chronic Heart Failure
A study testing NT-proBNP measurements in people with Heart Failure, Congestive, run by Netherlands Heart Foundation at 1 site in Netherlands.
Trial summary
The purpose of this study is to determine whether NT-proBNP guided treatment of chronic congestive heart failure will reduce heart failure related morbidity and mortality compared to therapy guided by standard clinical judgement. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure, Congestive
- What is being tested?
- NT-proBNP measurements
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteNetherlands
- Study dates
- Jun 2004to Apr 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Admission because of congestive heart failure
- Elevated NT-proBNP levels on admission
Who cannot join
- Life-threatening cardiac arrhythmias
- Urgent intervention
- Severe lung disease
- Presence of life threatening disease
- Signed informed consent for other study
- Mental or physical status not allowing written informed consent.
- Unwillingness to give informed consent
- Patients undergoing haemodialysis or continuous ambulatory peritoneal dialysis (CAPD)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Universtiy Hospital Maastricht
Maastricht, Limburg, 5800
About this study
Official title: Can Pro-brain-natriuretic Peptide Guided Therapy of Chronic Heart Failure Improve Heart Failure Morbidity and Mortality?
The purpose of this study is to determine whether NT-proBNP guided treatment of chronic congestive heart failure will reduce heart failure related morbidity and mortality compared to therapy guided by standard clinical judgement.
- Conditions
- Heart Failure, Congestive
- Being tested
- NT-proBNP measurements
- Keywords
- NT-proBNP
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NT-proBNP measurementsDevice
| Study group | Role | What they receive |
|---|---|---|
| NT-proBNP guided treatment group | Active comparator | In this group, management was guided by an individually set NT-proBNP, defined by the lowest level at discharge or 2 weeks thereafter. If NT-proBNP levels were elevated above the individually set NT-proBNP interventions were performed according to the ESC heart failure guidelines. Receives: Device: NT-proBNP measurements |
| Clinically guided arm | Placebo comparator | Heart failure treatment guided by clinical assessment. Receives: Device: NT-proBNP measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in total number of days alive and outside the hospital between the NT-proBNP guided and the clinical guided group.
Measured: minimum of one year
Secondary outcomes (9)
All cause mortality
Measured: at least one year
Cardiovascular mortality
Measured: at least one year
All cause hospitalization
Measured: at least one year
Cardiovascular related hospitalization
Measured: at least one year
Total number of hospitalizations and mortality
Measured: at least one year
Total number of cardiovascular hospitalizations and mortality
Measured: at least one year
Differences in primary and secondary outcome measures among renal function and age subgroups
Measured: At least one year
Differences in evidence based heart failure medication prescription after 3, 6 and 12 months
Measured: At least one year
Analysis of major endpoints in patients where NT-proBNP levels were at or below the individual target level in at least 75% of all outpatient visits
Measured: at least one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startJun 2004
- Primary completionJan 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure, CongestiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- Netherlands Heart Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- The Interuniversity Cardiology Institute of the Netherlands
- Investigators
- Dave JW van Kraaij, MD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00149422
- Sponsor's protocol ID
- 2003B131
- Status last verified
- Aug 2008
- First submitted
- 6 Sep 2005
- Last updated
- 9 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Eurlings LW, van Pol PE, Kok WE, van Wijk S, Lodewijks-van der Bolt C, Balk AH, Lok DJ, Crijns HJ, van Kraaij DJ, de Jonge N, Meeder JG, Prins M, Pinto YM. Management of chronic heart failure guided by individual N-terminal pro-B-type natriuretic peptide targets: results of the PRIMA (Can PRo-brain-natriuretic peptide guided therapy of chronic heart failure IMprove heart fAilure morbidity and mortality?) study. J Am Coll Cardiol. 2010 Dec 14;56(25):2090-100. doi: 10.1016/j.jacc.2010.07.030.
PubMed 21144969
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Pro-brain-natriuretic Peptide Guided Therapy of Chronic Heart Failure Improve Heart Failure Morbidity and Mortality?
- ClinicalTrials.gov ID
- NCT00149422
- Acronym / sponsor ID
- 2003B131
- Conditions
- Heart Failure, Congestive
- Keywords
- NT-proBNP
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Netherlands Heart FoundationUniversity, hospital or other
- Collaborators
- The Interuniversity Cardiology Institute of the Netherlands
- Study start
- Jun 2004
- Primary completion
- Jan 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 8 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether NT-proBNP guided treatment of chronic congestive heart failure will reduce heart failure related morbidity and mortality compared to therapy guided by standard clinical judgement.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NT-proBNP guided treatment group | Active comparator | Device: NT-proBNP measurementsIn this group, management was guided by an individually set NT-proBNP, defined by the lowest level at discharge or 2 weeks thereafter. If NT-proBNP levels were elevated above the individually set NT-proBNP interventions were performed according to the ESC heart failure guidelines. |
| Clinically guided arm | Placebo comparator | Device: NT-proBNP measurementsHeart failure treatment guided by clinical assessment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Admission because of congestive heart failure
- Elevated NT-proBNP levels on admission
Key exclusion criteria (8 listed)
- Life-threatening cardiac arrhythmias
- Urgent intervention
- Severe lung disease
- Presence of life threatening disease
- Signed informed consent for other study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NT-proBNP measurements | Device | Clinically guided arm, NT-proBNP guided treatment group |
Primary outcome
Difference in total number of days alive and outside the hospital between the NT-proBNP guided and the clinical guided group.
Time frame: minimum of one year
9 secondary outcomes
All cause mortality
Time frame: at least one year
Cardiovascular mortality
Time frame: at least one year
All cause hospitalization
Time frame: at least one year
Cardiovascular related hospitalization
Time frame: at least one year
Total number of hospitalizations and mortality
Time frame: at least one year
Total number of cardiovascular hospitalizations and mortality
Time frame: at least one year
Differences in primary and secondary outcome measures among renal function and age subgroups
Time frame: At least one year
Differences in evidence based heart failure medication prescription after 3, 6 and 12 months
Time frame: At least one year
Analysis of major endpoints in patients where NT-proBNP levels were at or below the individual target level in at least 75% of all outpatient visits
Time frame: at least one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2010.
- Derived from this study: PubMed 21144969Eurlings LW, van Pol PE, Kok WE, van Wijk S, Lodewijks-van der Bolt C, Balk AH, Lok DJ, Crijns HJ, van Kraaij DJ, de Jonge N, Meeder JG, Prins M, Pinto YM. Management of chronic heart failure guided by individual N-terminal pro-B-type natriuretic peptide targets: results of the PRIMA (Can PRo-brain-natriuretic peptide guided therapy of chronic heart failure IMprove heart fAilure morbidity and mortality?) study. J Am Coll Cardiol. 2010 Dec 14;56(25):2090-100. doi: 10.1016/j.jacc.2010.07.030.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dave JW van Kraaij, MD principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NT-proBNP measurements in people with Heart Failure, Congestive, run by Netherlands Heart Foundation at 1 site in Netherlands.
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 2 inclusion and 8 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 9 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Difference in total number of days alive and outside the hospital between the NT-proBNP guided and the clinical guided group. (time frame: minimum of one year). 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 NCT00149422, which also lists 1 linked publication.
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 9 Feb 2010.