Heart FailureNCT04377854
Prognostic Value of BNP in MCS - a 25 Year Follow up Study
An observational study of Heart Failure and Left Ventricular Assist Device, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
A biobank has been created to investigate the prognostic value of biomarkers (mainly BNP) in patients implanted with durable mechanical assist devices comparing patients with advanced HF supported by MCS with those who are transplanted and those who remain on optimal medical therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Left Ventricular Assist Device, Prognosis
- What is being tested?
- 2) Observation and collection and of blood sample
- How many people
- 1,000 participants
- Where
- 1 siteDenmark
- Study dates
- 18 Sep 2020to 1 Aug 2045
- How long will I take part?
- 25 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: All patients referred for evaluation for advanced HF treatment at the Rigshospitalet in Denmark. All patients with Advanced HF (regardless of type of adv HF treatment) at the contributing center will (hopefully) be included in this study.
Who may be able to join
- All patients referred for evaluation for advanced HF treatment at the Rigshospital in Denmark
- Age>18 years
Who cannot join
- No consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen, DK, 2100
Kiran Mirza, MD, +4535451442, kmir0003@regionh.dk
Finn Gustafsson, MD,PhD,DMSc., +4535459743, Finn.Gustafsson@regionh.dk
About this study
Official title: The Prognostic Value of proBNP in Patients Supported With Durable Mechanical Circulatory Assist Devices - a 25 Year Follow up Study.
A biobank has been created to investigate the prognostic value of biomarkers (mainly BNP) in patients implanted with durable mechanical assist devices comparing patients with advanced HF supported by MCS with those who are transplanted and those who remain on optimal medical therapy.
Patients will be followed up for 25 years after inclusion.
Read the detailed description
All patients referred for advanced HF treatment at the Dept of Cardiology at Rigshospitalet.
- Conditions
- Heart Failure, Left Ventricular Assist Device, Prognosis, Durable Mechanical Support Device
- Being tested
- Observation. No intervention per se., 2) Observation and collection and of blood sample
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation. No intervention per se.Other
Also called 1) Observation - No intervention
Observation. No intervention (no collection of blood).
2) Observation and collection and of blood sampleOther
Also called Blood sample
All patients evaluated for adv HF (HTX/LVAD) will be offered to contribute to this database; Blood samples will be collected from all at baseline. Patients receiving LVAD will contribute on a yearly basis (or until withdrawal of consent). For other patients no further blood will be collected unless they receive an LVAD at a later point.
| Study group | Role | What they receive |
|---|---|---|
| MCS recipients | All recipients of durable MCS will be followed up on a yearly basis with collection of blood sample and clinical data for 25 years. Receives: Other: 2) Observation and collection and of blood sample | |
| Recipient of cardiac transplant | All recipients of cardiac transplantation(s) will be followed up on a yearly basis with collection of clinical data for 25 years. Receives: Other: Observation. No intervention per se. | |
| Watchful waiting at Rigshospitalet | Patients referred for evaluation for treatment with advanced treatment (LVAD/HTX) but -for whatever reason- these pts will be on watchful waiting at the Rigshospitalet. Receives: Other: Observation. No intervention per se. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alive
Measured: 25 years from inclusion
Dead
Dead after inclusion in study
Measured: 25 years from inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start18 Sep 2020
- Primary completion1 Aug 2045 (estimated)
- Study completion1 Aug 2045 (estimated)
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.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 25 Years
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Finn Gustafsson, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04377854
- Sponsor's protocol ID
- H-19055497
- Status last verified
- Apr 2021
- First submitted
- 3 May 2020
- Last updated
- 5 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prognostic Value of proBNP in Patients Supported With Durable Mechanical Circulatory Assist Devices - a 25 Year Follow up Study.
- ClinicalTrials.gov ID
- NCT04377854
- Acronym / sponsor ID
- H-19055497
- Conditions
- Heart Failure, Left Ventricular Assist Device, Prognosis, Durable Mechanical Support Device
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 18 Sep 2020 (actual)
- Primary completion
- 1 Aug 2045 (estimated)
- Study completion
- 1 Aug 2045 (estimated)
- First posted
- 6 May 2020 (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.
A biobank has been created to investigate the prognostic value of biomarkers (mainly BNP) in patients implanted with durable mechanical assist devices comparing patients with advanced HF supported by MCS with those who are transplanted and those who remain on optimal medical therapy.
Patients will be followed up for 25 years after inclusion.
Detailed description
All patients referred for advanced HF treatment at the Dept of Cardiology at Rigshospitalet.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 25 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MCS recipients | – | Other: 2) Observation and collection and of blood sampleAll recipients of durable MCS will be followed up on a yearly basis with collection of blood sample and clinical data for 25 years. |
| Recipient of cardiac transplant | – | Other: Observation. No intervention per se.All recipients of cardiac transplantation(s) will be followed up on a yearly basis with collection of clinical data for 25 years. |
| Watchful waiting at Rigshospitalet | – | Other: Observation. No intervention per se.Patients referred for evaluation for treatment with advanced treatment (LVAD/HTX) but -for whatever reason- these pts will be on watchful waiting at the Rigshospitalet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients referred for evaluation for advanced HF treatment at the Rigshospitalet in Denmark. All patients with Advanced HF (regardless of type of adv HF treatment) at the contributing center will (hopefully) be included in this study.
Key inclusion criteria (2 listed)
- All patients referred for evaluation for advanced HF treatment at the Rigshospital in Denmark
- Age>18 years
Key exclusion criteria (1 listed)
- No consent
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 |
|---|---|---|
| Observation. No intervention per se.Also: 1) Observation - No interventionObservation. No intervention (no collection of blood). | Other | Recipient of cardiac transplant, Watchful waiting at Rigshospitalet |
| 2) Observation and collection and of blood sampleAlso: Blood sampleAll patients evaluated for adv HF (HTX/LVAD) will be offered to contribute to this database; Blood samples will be collected from all at baseline. Patients receiving LVAD will contribute on a yearly basis (or until withdrawal of consent). For other patients no further blood will be collected unless they receive an LVAD at a later point. | Other | MCS recipients |
Primary outcome
Alive
Time frame: 25 years from inclusion
Dead
Time frame: 25 years from inclusion
Dead after inclusion in study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
- Individual participant dataSharing planned: No
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Left Ventricular Assist Device, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 1 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: looking for participants now, as of the sponsor's last update on 5 May 2021. 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kiran Mirza, MD (+4535451442, KiranMirza@dadlnet.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alive (time frame: 25 years from inclusion). The study lists 2 primary outcomes in all. 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 5 May 2021.