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Heart Failure Precision Medicine Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04196842
Recruitment Status : Recruiting
First Posted : December 12, 2019
Last Update Posted : December 12, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

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.

Condition or disease Intervention/treatment Phase
Heart Failure Device: Telemonitoring devices Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Blinded until intervention is assigned to subject
Primary Purpose: Supportive Care
Official Title: Heart Failure Precision Medicine Study
Actual Study Start Date : October 16, 2019
Estimated Primary Completion Date : January 16, 2024
Estimated Study Completion Date : October 16, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Telemonitoring
Blood pressure and heart rate monitoring, scale, activity tracker.
Device: Telemonitoring devices
Set of telemonitoring devices: heart rate and blood pressure monitor, scale and activity tracker.

No Intervention: No intervention
No intervention.



Primary Outcome Measures :
  1. Rate of adverse outcomes in heart failure [ Time Frame: Five years from enrollment ]
    Rate of Mortality (all cause), hospitalization, Mechanical circulatory support device (MCSD) or heart transplant (HTx)


Secondary Outcome Measures :
  1. Disease progression [ Time Frame: Five years from enrollment ]
    Disease severity (ACC/AHA Heart Failure classification system)


Other Outcome Measures:
  1. Percentage of guideline-directed medical therapy (GDMT). [ Time Frame: One year from enrollment ]
    Percentage of GDMT target doses



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04196842


Contacts
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Contact: Erick S Romero, MD (916) 703-2071 esromero@ucdavis.edu

Locations
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United States, California
UC Davis Medical Center Recruiting
Sacramento, California, United States, 95817
Contact: Erick Romero, MD    916-703-2071    esromero@ucdavis.edu   
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Martin Cadeiras, MD University of California, Davis
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT04196842    
Other Study ID Numbers: 1471560
First Posted: December 12, 2019    Key Record Dates
Last Update Posted: December 12, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, Davis:
Heart Failure
Multi-omics
Phenomapping
Precision medicine
Telemonitoring
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases