Heart Failure Precision Medicine Study

Heart Failure Clinical Trial

Official title:

Heart Failure Precision Medicine Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04196842
• Other study ID #: 1471560
• Status: Recruiting
• Phase: N/A
• Start date: October 16, 2019
• Est. completion date: October 16, 2026

Study information

• Verified date: May 2024
• Source: University of California, Davis
• Contact: Erick S Romero, MD
• Phone: (916) 703-2071
• Email: esromero[@]ucdavis.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study aims to test the hypothesis that multi-omics studies can identify Heart Failure profiles at risk of adverse outcomes and evaluate a telemonitoring intervention in the optimization of guideline-directed medical therapy.

Description:

In the US, the estimated prevalence of Heart Failure (HF) is 6.2 million and increasing. The mortality approaches 50% within 5 years of diagnosis and HF is the main cause of hospitalization among patients over 65 years of age. Information on molecular states may enhance understanding of causes and pathophysiological processes, improve risk prediction, identify new therapeutic targets, and improve subclassification for targeted therapy. Time-dependent phenomapping has been used to identify clinical and genomic differences in a longitudinal fashion, which provides a mechanistic link underlying pathophysiology of the disease and associated outcomes. Studies including high-throughput molecular approaches (multi-omics) along with time-dependent phenomapping would likely be even more powerful. The overarching hypothesis of the study is that the integration of Multi-Omics studies with clinical variables can be implemented to identify patients at risk of adverse outcomes. To test this hypothesis we propose: (1) Longitudinal profiling based on clinical data; (2) Longitudinal Multi-Omics Profiling; and (3) randomized of a telemonitoring intervention (Sensor Profiling) and the effectiveness in the optimization of guideline-directed medical therapy. To achieve these aims we propose to: (1) recruit a cohort of 1000 participants; (2) perform cardiovascular clinical characterization from electronic medical records; (3) perform multi-omics studies and (4) randomization of a telemonitoring intervention in the optimization of guideline-directed medical therapy. Proving these hypotheses would identify different meaningful clinical groups of patients within a cohort of patients with similar clinical conditions, health care providers would have a better understanding of the heterogeneity of the disease and the need for different preventive and therapeutic approaches in the context of precision medicine.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 16, 2026
• Est. primary completion date: January 16, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of Heart failure

• Objective evidence of cardiac abnormality of structure or function (abnormal ECHO) or elevated levels of B-type natriuretic peptide (>100 pg/ml)

• HF stage B-D and class I-IV

Exclusion Criteria:

• Patients unable to consent

• Inability to comply with the protocol and follow-up requirements

• Patients unable to use a smartphone

• Patients assessed irregularly (less than two visits in one year)

• History of HTx

• Use of Mechanical circulatory support device (MCSD)

• Comorbidities that, according to the PI, have the potential to interfere with the interpretation of the results

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Telemonitoring devices
Set of telemonitoring devices: heart rate and blood pressure monitor, scale and activity tracker.

Locations

Country	Name	City	State
United States	UC Davis Medical Center	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of guideline-directed medical therapy (GDMT).	Percentage of GDMT target doses	One year from enrollment
Primary	Rate of adverse outcomes in heart failure	Rate of Mortality (all cause), hospitalization, Mechanical circulatory support device (MCSD) or heart transplant (HTx)	Five years from enrollment
Secondary	Disease progression	Disease severity (ACC/AHA Heart Failure classification system)	Five years from enrollment

External Links

•   Learn more or sign up for the study here!