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Recruiting NCT04196842

Heart Failure Precision Medicine Study

No phase Interventional Heart Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Telemonitoring devices.
Who it may be relevant to
Registry conditions: Heart Failure. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

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

Primary outcome measures

  • Rate of adverse outcomes in heart failure [Time frame: Five years from enrollment]
Secondary outcome measures (1)
  • Disease progression [Time frame: Five years from enrollment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Supportive care

Study locations

United States · 1 center
  • UC Davis Medical Center — Sacramento

Identifiers

NCT: NCT04196842 · 1471560

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗