Heart FailureRespondersNCT06435585
Responders and Non-responders in the Management of Heart Failure - Significance of Genetic Influence and Identification of Novel Informative Biomarkers
An observational study of Heart Failure and Pathophysiology, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
A biobank within the Swedish national heart failure quality registry SwedeHF. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Pathophysiology
- How many people
- 5,000 participants
- Where
- 1 siteSweden
- Study dates
- 17 Feb 2021to 31 Dec 2030
- 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
- No healthy volunteers
- Adult, Older adult
Study population: PAtients with heart failure in Sweden with a registration in SwedeHF.
Who may be able to join
- Written informed consent
- Heart failure defined by symptoms and signs of heart failure as judged by the local investigator
- Registered in SwedeHF
Who cannot join
- Plasma donation within 1 month of enrolment or any blood donation/blood loss >500 mL during the 3 months prior to enrolment
- Previous allogeneic bone marrow transplant (genetics)
- In the opinion of the investigator, condition/s that may either put the patient at risk on participation or influence the results or the patient's ability to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ulf Dahlström, Prof contact
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University hospital
Stockholm, 17164
Camilla Hage, Ass prof, +46 (0)703340660, camilla.hage@regionstockholm.se
Ulf Dahlström, MD, Prof
About this study
A biobank within the Swedish national heart failure quality registry SwedeHF.
Read the detailed description
The national heart failure quality registry SwedeHF started in 2003. It is the world's largest continuous HF registry enrolling clinician-judged HF (regardless of LVEF) at time of hospital or clinical visit. Eighty variables are entered into an electronic database managed by the Uppsala Clinical Research Center (UCR). There are >140,000 registrations from >110,000 unique patients from 70 hospitals in Sweden.
University hospitals in Sweden with access to central biobanking will collect a high-quality biobank linked to SwedeHF consisting of blood plasma, whole blood and urine enabling genetic, proteomic and metabolomic analyses as well as analyses of different biomarkers of interest for HF patients. This will provide unique opportunities for future research within the national SwedeHF registry.
- Conditions
- Heart Failure, Pathophysiology
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify responders to guideline-directed medical therapy
To identify which patient will be a non-responder resulting in a poor outcome, despite being on recommended treatment according to guidelines.
Measured: 2 and 5 years
Differences in morbidity between responders and non-responders to guideline-directed medical therapy
To characterize differences between responders and non-responders in terms of morbidity after 2-years follow-up.
Measured: 2 years
Differences in mortality between responders and non-responders to guideline-directed medical therapy
To characterize differences between responders and non-responders in terms of mortality after 2-years follow-up.
Measured: 2 years
Predictors of responders and non-responders to guideline-directed medical therapy
To integrate information regarding clinical characteristics, diagnostic markers and genetics to determine underlying mechanisms behind different responses to treatment.
Measured: 2 and 5 years
Secondary outcomes (4)
Differences between responders and non-responders regarding mortality
To evaluate the differences between HFrEF and HFpEF patients in terms of mortality and after 2 and 5 years follow-up, respectively.
Measured: 2 and 5 years
Differences between responders and non-responders regarding morbidity
- evaluate the differences between HFrEF and HFpEF patients in terms of morbidity after 2 and 5 years follow-up, respectively.
Measured: 2 and 5 years
Predictors of mortality in responders and non-responders
To evaluate the differences in mortality between patients with HFrEF and HFpEF by integrating information from clinical characteristics, diagnostic markers and genetics in order to have a further understanding of the underlying pathophysiology involved in HF development and prognosis with the aim to facilitate improved individualized therapy with less adverse effects and to identify novel treatment targets.
Measured: 2 and 5 years
Predictors of morbidity in responders and non-responders
To evaluate the differences in morbidity between patients with HFrEF and HFpEF by integrating information from clinical characteristics, diagnostic markers and genetics in order to have a further understanding of the underlying pathophysiology involved in HF development and prognosis with the aim to facilitate improved individualized therapy with less adverse effects and to identify novel treatment targets.
Measured: 2 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start17 Feb 2021
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
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 FailureStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe 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
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Linkoeping
- Responsible party
- Principal investigator, Camilla Hage, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06435585
- Sponsor's protocol ID
- 218/443-31
- Acronym
- Responders
- Status last verified
- Aug 2025
- First submitted
- 20 May 2024
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data sharing will only be within investigators. Beyond study investigators data sharing requires new ethical approval.
Publications
Hage C, Andersson T, Christersson C, Linde C, Lund LH, Karlstrom P, Chatziapostolou D, Dagner V, Granstrom F, Gylling A, Jonsson A, Haglund P, Hogberg J, Odenstedt A, Viklund U, Magnusson M, Smith JG, Szabo-Soderberg B, Ostgard Thunstrom E, Dahlstrom U. An integrated Biobank in the Swedish Heart Failure Registry-clinomics, proteomics, transcriptomics and genomics. ESC Heart Fail. 2026 Mar 3;13(2):xvag092. doi: 10.1093/eschf/xvag092.
PubMed 41961636
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Responders and Non-responders in the Management of Heart Failure - Significance of Genetic Influence and Identification of Novel Informative Biomarkers
- ClinicalTrials.gov ID
- NCT06435585
- Acronym / sponsor ID
- Responders / 218/443-31
- Conditions
- Heart Failure, Pathophysiology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- University Hospital, Linkoeping
- Study start
- 17 Feb 2021 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 30 May 2024 (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 within the Swedish national heart failure quality registry SwedeHF.
Detailed description
The national heart failure quality registry SwedeHF started in 2003. It is the world's largest continuous HF registry enrolling clinician-judged HF (regardless of LVEF) at time of hospital or clinical visit. Eighty variables are entered into an electronic database managed by the Uppsala Clinical Research Center (UCR). There are >140,000 registrations from >110,000 unique patients from 70 hospitals in Sweden.
University hospitals in Sweden with access to central biobanking will collect a high-quality biobank linked to SwedeHF consisting of blood plasma, whole blood and urine enabling genetic, proteomic and metabolomic analyses as well as analyses of different biomarkers of interest for HF patients. This will provide unique opportunities for future research within the national SwedeHF registry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- PAtients with heart failure in Sweden with a registration in SwedeHF.
Key inclusion criteria (3 listed)
- Written informed consent
- Heart failure defined by symptoms and signs of heart failure as judged by the local investigator
- Registered in SwedeHF
Key exclusion criteria (3 listed)
- Plasma donation within 1 month of enrolment or any blood donation/blood loss >500 mL during the 3 months prior to enrolment
- Previous allogeneic bone marrow transplant (genetics)
- In the opinion of the investigator, condition/s that may either put the patient at risk on participation or influence the results or the patient's ability to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identify responders to guideline-directed medical therapy
Time frame: 2 and 5 years
To identify which patient will be a non-responder resulting in a poor outcome, despite being on recommended treatment according to guidelines.
Differences in morbidity between responders and non-responders to guideline-directed medical therapy
Time frame: 2 years
To characterize differences between responders and non-responders in terms of morbidity after 2-years follow-up.
Differences in mortality between responders and non-responders to guideline-directed medical therapy
Time frame: 2 years
To characterize differences between responders and non-responders in terms of mortality after 2-years follow-up.
Predictors of responders and non-responders to guideline-directed medical therapy
Time frame: 2 and 5 years
To integrate information regarding clinical characteristics, diagnostic markers and genetics to determine underlying mechanisms behind different responses to treatment.
4 secondary outcomes
Differences between responders and non-responders regarding mortality
Time frame: 2 and 5 years
Differences between responders and non-responders regarding morbidity
Time frame: 2 and 5 years
Predictors of mortality in responders and non-responders
Time frame: 2 and 5 years
Predictors of morbidity in responders and non-responders
Time frame: 2 and 5 years
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 10 Aug 2026.
- Derived from this study: PubMed 41961636Hage C, Andersson T, Christersson C, Linde C, Lund LH, Karlstrom P, Chatziapostolou D, Dagner V, Granstrom F, Gylling A, Jonsson A, Haglund P, Hogberg J, Odenstedt A, Viklund U, Magnusson M, Smith JG, Szabo-Soderberg B, Ostgard Thunstrom E, Dahlstrom U. An integrated Biobank in the Swedish Heart Failure Registry-clinomics, proteomics, transcriptomics and genomics. ESC Heart Fail. 2026 Mar 3;13(2):xvag092. doi: 10.1093/eschf/xvag092.
- Individual participant dataSharing planned: Undecided. Data sharing will only be within investigators. Beyond study investigators data sharing requires new ethical approval.
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.
Ulf Dahlström, Prof contact
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 Pathophysiology, run by Karolinska University Hospital at 1 site 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 3 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 10 Aug 2026. 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 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.
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 Camilla Hage, Ass prof (+46 (0)703340660, camilla.hage@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify responders to guideline-directed medical therapy (time frame: 2 and 5 years). The study lists 4 primary outcomes in all. 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 NCT06435585, 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 10 Aug 2026.