Heart Failure Precision Medicine Study

NCT04196842 | Recruiting DMC

• 1 other identifier: 1471560
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Heart Failure; Multi-omics; Phenomapping; Precision medicine; Telemonitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Disease progression

  Five years from enrollment

Other Outcomes (1)

• Percentage of guideline-directed medical therapy (GDMT).

  One year from enrollment

Study Arms (2)

Telemonitoring

EXPERIMENTAL

Blood pressure and heart rate monitoring, scale, activity tracker.

Device: Telemonitoring devices

No intervention

NO INTERVENTION

No intervention.

Interventions

Telemonitoring devices DEVICE

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

Telemonitoring

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis Medical Center

Sacramento, California, 95817, United States

RECRUITING

Related Links

• Learn more or sign up for the study here!

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Martin Cadeiras, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erick S Romero, MD

CONTACT

(916) 703-2071; esromero@ucdavis.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinded until intervention is assigned to subject
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: December 12, 2019
• Study Start: October 16, 2019
• Primary Completion (Estimated): October 16, 2026
• Study Completion (Estimated): October 16, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)