Heart FailureBIOCARDIUM-HFNCT07158086
Molecular Underpinnings of Heart Failure, Integrative Multi-Omics, and Non-Coding RNA Profiling
An observational study of Heart Failure and Heart Failure (for Example, Fluid Overload), run by University of Zurich at 1 site in Switzerland.
Trial summary
The main objective of the study is to achieve a comprehensive phenotyping of patients with heart failure, combining detailed clinical characterization with in-depth molecular profiling. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure, Heart Failure (for Example, Fluid Overload)
- How many people
- 500 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2025to 30 Nov 2031
- How long will I take part?
- 5 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study aims to enroll all patients presenting with clinical signs and symptoms of acute heart failure. As this is an all-comer cohort, the investigators expect no selection bias in terms of sex and gender.
Who may be able to join
- Female and Male, age ≥18 years at screening.
- Diagnosis of Heart Failure according to ESC Heart Failure Guidelines
- Ability to understand the requirements of the study and to provide informed consent.
- Willingness to undergo follow-up.
Who cannot join
- Patients will be excluded if they meet any of the following conditions:
- Active malignancy or history of cancer with ongoing treatment (e.g., chemotherapy, radiotherapy, immunotherapy).
- Autoimmune or systemic inflammatory diseases.
- Concomitant infections, including acute systemic infections (e.g., sepsis, pneumonia) or chronic infections with systemic impact (e.g., HIV, hepatitis B/C with elevated transaminases).
- Other exclusion criteria:
- Age<18 years old
- Inability to provide written informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital of Zurich
Zurich, 8091
Jan A Kleeberger, MD, +41763220376, janalphard.kleeberger@usz.ch
janalphard.kleeberger@usz.ch
About this study
Official title: Molecular Underpinnings of Heart Failure, Integrative Multi-Omics, and Non-Coding RNA Profiling: the BIOCARDIUM-HF Study
The main objective of the study is to achieve a comprehensive phenotyping of patients with heart failure, combining detailed clinical characterization with in-depth molecular profiling. By integrating clinical data with cutting-edge multi-omics techniques (including transcriptomics, epigenomics, and proteomics), this research aims to identify molecular signatures, particularly non-coding RNAs (ncRNAs), that are linked to the onset and progression of HF. Through advanced molecular profiling of biological samples and the analysis of clinical parameters, including advanced imaging, hemodynamic profiling, and biomarker analysis, the study will contribute to the deep phenotyping of HF patients.
The secondary objective aims to uncover potential biomarkers that may serve as predictive indicators of disease progression and identify novel therapeutic targets, offering promising avenues for future treatments in this challenging patient population.
- Medical subject headings
- Heart Failure, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Heart Failure with reduced ejection fraction (HFrEF) | LVEF <40% | |
| Heart Failure with preserved ejection fraction (HFpEF) | LVEF >50% | |
| Heart Failure with mildyly reduced ejection fraction (HFmrEF) | LVEF >40% and <50% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death from any cause
Measured: From enrollment up to five years
Heart failure hospitalization
Measured: From enrollment up to five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start1 Feb 2025
- Primary completion30 Nov 2030 (estimated)
- Study completion30 Nov 2031 (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 University of ZurichThe 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
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Kleeberger, University of Zurich
- Investigators
- Jan A Kleeberger, MD, Principal investigator, Universitätsspital ZürichFrancesco Paneni, MD, PhD, Study director, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07158086
- Sponsor's protocol ID
- 25_0908
- Acronym
- BIOCARDIUM-HF
- Status last verified
- Sep 2025
- First submitted
- 27 Aug 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Underpinnings of Heart Failure, Integrative Multi-Omics, and Non-Coding RNA Profiling: the BIOCARDIUM-HF Study
- ClinicalTrials.gov ID
- NCT07158086
- Acronym / sponsor ID
- BIOCARDIUM-HF / 25_0908
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 30 Nov 2030 (estimated)
- Study completion
- 30 Nov 2031 (estimated)
- First posted
- 5 Sep 2025 (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.
The main objective of the study is to achieve a comprehensive phenotyping of patients with heart failure, combining detailed clinical characterization with in-depth molecular profiling. By integrating clinical data with cutting-edge multi-omics techniques (including transcriptomics, epigenomics, and proteomics), this research aims to identify molecular signatures, particularly non-coding RNAs (ncRNAs), that are linked to the onset and progression of HF. Through advanced molecular profiling of biological samples and the analysis of clinical parameters, including advanced imaging, hemodynamic profiling, and biomarker analysis, the study will contribute to the deep phenotyping of HF patients.
The secondary objective aims to uncover potential biomarkers that may serve as predictive indicators of disease progression and identify novel therapeutic targets, offering promising avenues for future treatments in this challenging patient population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Heart Failure with reduced ejection fraction (HFrEF) | – | –LVEF <40% |
| Heart Failure with preserved ejection fraction (HFpEF) | – | –LVEF >50% |
| Heart Failure with mildyly reduced ejection fraction (HFmrEF) | – | –LVEF >40% and <50% |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study aims to enroll all patients presenting with clinical signs and symptoms of acute heart failure. As this is an all-comer cohort, the investigators expect no selection bias in terms of sex and gender.
Key inclusion criteria (4 listed)
- Female and Male, age ≥18 years at screening.
- Diagnosis of Heart Failure according to ESC Heart Failure Guidelines
- Ability to understand the requirements of the study and to provide informed consent.
- Willingness to undergo follow-up.
Key exclusion criteria (7 listed)
- Active malignancy or history of cancer with ongoing treatment (e.g., chemotherapy, radiotherapy, immunotherapy).
- Autoimmune or systemic inflammatory diseases.
- Concomitant infections, including acute systemic infections (e.g., sepsis, pneumonia) or chronic infections with systemic impact (e.g., HIV, hepatitis B/C with elevated transaminases).
- Age<18 years old
- Inability to provide written informed consent
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
Death from any cause
Time frame: From enrollment up to five years
Heart failure hospitalization
Time frame: From enrollment up to five 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 25 Sep 2026.
- Individual participant dataSharing planned: Undecided
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.
Jan A Kleeberger, MD principal investigator
Universitätsspital Zürich
Francesco Paneni, MD, PhD study director
University of Zurich
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 Heart Failure (for Example, Fluid Overload), run by University of Zurich at 1 site in Switzerland.
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 4 inclusion and 7 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 25 Sep 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 Switzerland. 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 Jan A Kleeberger, MD (+41763220376, janalphard.kleeberger@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death from any cause (time frame: From enrollment up to five years). 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 25 Sep 2026.