Heart Failure
Conditions
Keywords
Heart Failure, Multi-omics, Phenomapping, Precision medicine, Telemonitoring
Brief 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.
Detailed 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.
Interventions
DEVICETelemonitoring devices
Set of telemonitoring devices: heart rate and blood pressure monitor, scale and activity tracker.
Sponsors
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Blinded until intervention is assigned to subject
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of adverse outcomes in heart failure | Five years from enrollment | Rate of Mortality (all cause), hospitalization, Mechanical circulatory support device (MCSD) or heart transplant (HTx) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease progression | Five years from enrollment | Disease severity (ACC/AHA Heart Failure classification system) |
Countries
United States
Contacts
CONTACTErick S Romero, MD
PRINCIPAL_INVESTIGATORMartin Cadeiras, MD
University of California, Davis
Outcome results
None listed