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

NCT07158086 | Not Yet Recruiting

• 1 other identifier: 25_0908
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (2)

• Death from any cause

  From enrollment up to five years

• Heart failure hospitalization

  From enrollment up to five years

Study Arms (3)

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%

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital of Zurich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Heart Failure; Edema

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jan A Kleeberger, MD

  Universitätsspital Zürich

  PRINCIPAL INVESTIGATOR

• Francesco Paneni, MD, PhD

  University of Zurich

  STUDY DIRECTOR

Central Study Contacts

Jan A Kleeberger, MD

CONTACT

+41763220376; janalphard.kleeberger@usz.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 5, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 30, 2030
• Study Completion (Estimated): November 30, 2031
• Last Updated: September 10, 2025

Record last verified: 2025-09

Locations

CH (1)