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Telemonitoring for Heart Failure
N/A
Recruiting
Led By Martin Cadeiras, MD
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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)
Must not have
Patients unable to consent
History of HTx
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year from enrollment
Awards & highlights
No Placebo-Only Group
Summary
This trial will test whether using data from different 'omics' studies can help identify people at risk for heart failure, and whether a telemonitoring intervention can help optimize their care.
Who is the study for?
This trial is for individuals with heart failure who have evidence of cardiac issues or high levels of a specific heart stress marker. They must be in any stage or class of heart failure, able to consent, follow the study's protocol, use a smartphone regularly, and not have had a heart transplant or mechanical circulatory support.
What is being tested?
The study is exploring if advanced testing can predict which patients with heart failure are at higher risk and whether monitoring these patients using telemonitoring devices can help optimize their treatment according to established guidelines.
What are the potential side effects?
Since this trial involves telemonitoring devices rather than medication, side effects may include discomfort from wearing the device and potential privacy concerns related to data transmission. There might also be psychological impacts due to constant health monitoring.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with heart failure.
Select...
I have heart issues shown by tests or high BNP levels.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am unable to give consent by myself.
Select...
I have had a heart transplant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ five years from enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~five years from enrollment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Rate of adverse outcomes in heart failure
Secondary study objectives
Disease progression
Other study objectives
Percentage of guideline-directed medical therapy (GDMT).
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: TelemonitoringExperimental Treatment1 Intervention
Blood pressure and heart rate monitoring, scale, activity tracker.
Group II: No interventionActive Control1 Intervention
No intervention.
Find a Location
Who is running the clinical trial?
University of California, DavisLead Sponsor
942 Previous Clinical Trials
4,755,575 Total Patients Enrolled
6 Trials studying Heart Failure
2,490 Patients Enrolled for Heart Failure
Martin Cadeiras, MDPrincipal InvestigatorUniversity of California, Davis
1 Previous Clinical Trials
9 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can follow the study's rules and attend all required visits.I am unable to give consent by myself.You are using a mechanical circulatory support device.My heart failure is between stages B to D and class I to IV.I have been diagnosed with heart failure.I have heart issues shown by tests or high BNP levels.I have had a heart transplant.You have not been seeing your doctor regularly (less than two visits in one year).
Research Study Groups:
This trial has the following groups:- Group 1: No intervention
- Group 2: Telemonitoring
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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