Recruiting

Heart Failure

Sponsor:

UCLA

Code:

NCT04196842

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Telemonitoring devices

Study Details

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

Study ID

NCT04196842

Start date

Oct 16, 2019

Status verified date

Feb, 2026

Completion date

Oct 16, 2026

Anticipated

Primary completion date

Oct 16, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Telemonitoring

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

no intervention: No intervention

No intervention.

Interventions

Telemonitoring devices

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

Primary outcome measure

  • Rate of adverse outcomes in heart failure [ Time Frame: Five years from enrollment ]

Central Contacts and Locations

Central contacts

Erick S Romero, MD

(916) 703-2071esromero@ucdavis.edu

Locations

UC Davis Medical Center

Recruiting

Sacramento, California, United States, 95817

Contacts

Pablo Acevedo, BS

916-703-2071peacevedo@ucdavis.edu

More Information

Sponsor

University of California, Davis

Last update posted

Feb 9, 2026

Last verified

Feb, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Davis on 2026-02-09.