Molecular Underpinnings of Heart Failure, Integrative Multi-Omics, and Non-Coding RNA Profiling

NCT ID: NCT07158086

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2031-11-30

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.

Conditions

Heart Failure; Heart Failure (for Example, Fluid Overload)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Heart Failure with reduced ejection fraction (HFrEF)

LVEF \<40%

No interventions assigned to this group

Heart Failure with preserved ejection fraction (HFpEF)

LVEF \>50%

No interventions assigned to this group

Heart Failure with mildyly reduced ejection fraction (HFmrEF)

LVEF \>40% and \<50%

No interventions assigned to this group

Eligibility Criteria

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).

• Age<18 years old
• Inability to provide written informed consent

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Jan Kleeberger

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jan A Kleeberger, MD

Role: PRINCIPAL_INVESTIGATOR

Universitätsspital Zürich

Francesco Paneni, MD, PhD

Role: STUDY_DIRECTOR

University of Zurich

Locations

University Hospital of Zurich

Zurich, , Switzerland

Countries

Switzerland

Central Contacts

Jan A Kleeberger, MD

Role: CONTACT

janalphard.kleeberger@usz.ch

+41763220376

Facility Contacts

Jan A Kleeberger, MD

Role: primary

janalphard.kleeberger@usz.ch

+41763220376

Role: backup

janalphard.kleeberger@usz.ch

Other Identifiers

25_0908

Identifier Type: -

Identifier Source: org_study_id