Heart Failure Precision Medicine Study

• ClinicalTrials.gov Identifier: NCT04196842
• Recruitment Status: Recruiting
• First Posted: December 12, 2019
• Last Update Posted: February 17, 2022
• Sponsor: University of California, Davis
• Information provided by (Responsible Party): University of California, Davis

Study Description

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Contacts

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

Locations

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

• Principal Investigator: Martin Cadeiras, MD; University of California, Davis

More Information

Additional Information:

Learn more or sign up for the study here! 

• Responsible Party: University of California, Davis
• ClinicalTrials.gov Identifier: NCT04196842
• Other Study ID Numbers: 1471560
• First Posted: December 12, 2019
• Last Update Posted: February 17, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Heart Failure; Heart Diseases; Cardiovascular Diseases