Heart FailureSONGBIRDNCT04061811
Soluble Neprilysin, NT-proBNP, and Growth-Differentiation-Factor-15 as Biomarkers for Heart Failure in Dialysis Patients
An observational study of Heart Failure and End Stage Renal Disease, run by Hannover Medical School at 2 sites in 2 countries.
Trial summary
Objectives: The aim of this study is to determine whether growth differentiation factor-15 (GDF15) and circulating neprilysin (cNEP) improve the diagnosis of congestive heart failure (HF) in patients on dialysis. Background: Dialysis patients are at increased risk of HF. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, End Stage Renal Disease
- What is being tested?
- Diagnostic biomarker study
- How many people
- 153 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Aug 2018to 28 Feb 2019
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: End stage renal disease (ESRD) patients on chronic dialysis.
Who may be able to join
- ESRD on either chronic hemodialysis (HD) or peritoneal dialysis (PD) for ≥3 months
Who cannot join
- previous switch of the type of renal replacement therapy from HD to PD or vice versa
- age <18 years
- pregnancy
- plasma exchange or apheresis in the past 6 months
- unipolar pacemaker
- history of whole extremity amputation
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Objectives: The aim of this study is to determine whether growth differentiation factor-15 (GDF15) and circulating neprilysin (cNEP) improve the diagnosis of congestive heart failure (HF) in patients on dialysis.
Background: Dialysis patients are at increased risk of HF. However, diagnostic utility of NT-proBNP as a biomarker is decreased in patients on dialysis. GDF15 and cNEP are biomarkers of distinct mechanisms that may contribute to HF pathophysiology in such cohorts.
Methods: We compare circulating concentrations of NT-proBNP, GDF15, and cNEP along with NEP activity in patients on chronic dialysis without and with HF, as diagnosed by clinical parameters and post-dialysis echocardiography. We use correlation, linear and logistic regression as well as receiver operating characteristic (ROC) analyses.
- Conditions
- Heart Failure, End Stage Renal Disease
- Being tested
- Diagnostic biomarker study
- Keywords
- congestive heart failure (HF), biomarker, chronic kidney disease (CKD), hemodialysis (HD), peritoneal dialysis (PD), neprilysin (NEP), growth differentiation factor-15 (GDF15)
- Medical subject headings
- Heart Failure, Kidney Failure, Chronic, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic biomarker studyDiagnostic test
Comparing circulating concentrations of NT-proBNP, GDF15, and neprilysin (NEP) along with NEP activity in patients with and without HF, as diagnosed by clinical parameters and post-dialysis echocardiography.
| Study group | Role | What they receive |
|---|---|---|
| HF (heart failure) | Patients with end stage renal disease requiring dialysis with reduced or preserved ejection fraction. Receives: Diagnostic Test: Diagnostic biomarker study | |
| Control | Patients with end stage renal disease requiring dialysis without HF. Receives: Diagnostic Test: Diagnostic biomarker study |
What is being measured
The primary outcome is the main question the study is designed to answer.
HF diagnosis
Diagnosis of HF
Measured: Baseline (at study entry (diagnostic biomarker study))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start1 Aug 2018
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, F-CRIN
- Responsible party
- Principal investigator, Michael Sören Balzer, Hannover Medical School
- Investigators
- Michael S Balzer, MD, Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04061811
- Sponsor's protocol ID
- 7952_BO_S_2018
- Other IDs
- KlinStrucMed program
- Acronym
- SONGBIRD
- Status last verified
- Aug 2019
- First submitted
- 16 Aug 2019
- Last updated
- 20 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soluble Neprilysin, NT-proBNP, and Growth-Differentiation-Factor-15 as Biomarkers for Heart Failure in Dialysis Patients
- ClinicalTrials.gov ID
- NCT04061811
- Acronym / sponsor ID
- SONGBIRD / 7952_BO_S_2018
- Conditions
- Heart Failure, End Stage Renal Disease
- Keywords
- congestive heart failure (HF), biomarker, chronic kidney disease (CKD), hemodialysis (HD), peritoneal dialysis (PD), neprilysin (NEP), growth differentiation factor-15 (GDF15)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, F-CRIN
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 20 Aug 2019 (actual)
- 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.
Objectives: The aim of this study is to determine whether growth differentiation factor-15 (GDF15) and circulating neprilysin (cNEP) improve the diagnosis of congestive heart failure (HF) in patients on dialysis.
Background: Dialysis patients are at increased risk of HF. However, diagnostic utility of NT-proBNP as a biomarker is decreased in patients on dialysis. GDF15 and cNEP are biomarkers of distinct mechanisms that may contribute to HF pathophysiology in such cohorts.
Methods: We compare circulating concentrations of NT-proBNP, GDF15, and cNEP along with NEP activity in patients on chronic dialysis without and with HF, as diagnosed by clinical parameters and post-dialysis echocardiography. We use correlation, linear and logistic regression as well as receiver operating characteristic (ROC) analyses.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HF (heart failure) | – | Diagnostic Test: Diagnostic biomarker studyPatients with end stage renal disease requiring dialysis with reduced or preserved ejection fraction. |
| Control | – | Diagnostic Test: Diagnostic biomarker studyPatients with end stage renal disease requiring dialysis without HF. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- End stage renal disease (ESRD) patients on chronic dialysis.
Key inclusion criteria (1 listed)
- ESRD on either chronic hemodialysis (HD) or peritoneal dialysis (PD) for ≥3 months
Key exclusion criteria (6 listed)
- previous switch of the type of renal replacement therapy from HD to PD or vice versa
- age <18 years
- pregnancy
- plasma exchange or apheresis in the past 6 months
- unipolar pacemaker
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 |
|---|---|---|
| Diagnostic biomarker studyComparing circulating concentrations of NT-proBNP, GDF15, and neprilysin (NEP) along with NEP activity in patients with and without HF, as diagnosed by clinical parameters and post-dialysis echocardiography. | Diagnostic test | Control, HF (heart failure) |
Primary outcome
HF diagnosis
Time frame: Baseline (at study entry (diagnostic biomarker study))
Diagnosis of HF
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 20 Aug 2019.
- Individual participant dataSharing planned: No
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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.
Michael S Balzer, MD principal investigator
Hannover Medical School
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and End Stage Renal Disease, run by Hannover Medical School at 2 sites in 2 countries.
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 1 inclusion and 6 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 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, Germany. 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.
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?
HF diagnosis (time frame: Baseline (at study entry (diagnostic biomarker study))). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2019.