Molecular Underpinnings of Heart Failure, Integrative Multi-Omics, and Non-Coding RNA Profiling: the BIOCARDIUM-HF Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Zurich
- Enrollment
- 500
- Locations
- 2
- Primary Endpoint
- Heart failure hospitalization
Study Overview
Brief 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. 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
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Arms & Interventions
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%
Outcomes
Primary Outcomes
Heart failure hospitalization
Time Frame: From enrollment up to five years
Death from any cause
Time Frame: From enrollment up to five years
Secondary Outcomes
No secondary outcomes reported
Investigators
Jan Kleeberger
Principal Investigator
University of Zurich