Evaluation Of A Virtual Cardiology Program To Improve Outcomes After Acute Decompensated Heart Fa… (NCT06592508) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Evaluation Of A Virtual Cardiology Program To Improve Outcomes After Acute Decompensated Heart Failure
United States180 participantsStarted 2024-09-27
Plain-language summary
The purpose of this study is to evaluate how safe and effective a remote, virtual, cardiology program is that provides heart failure education to patients, monitors for worsening heart failure, and quickly adjusts heart failure medications, compared to usual care medication use and adjustment, in participants with decompensated heart failure that are recently hospitalized.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Age ≥18 years of age
* Acute decompensated HF as a primary cause of hospitalization. Hospitalizations for acute decompensated HF will be determined by local clinician-investigators but should include findings of acute HF (i.e., symptoms, signs, and/or laboratory/imaging abnormalities) and treatments aimed at acute HF (e.g., intravenous diuretics, vasodilators, or inotropes). Participants with a new diagnosis of HF may be enrolled. The enrollment will be monitored to ensure no more than 2/3 of the total cohort has new-onset HF.
* Fluent in written and spoken English
Exclusion Criteria:
* Optimized or nearly optimized on evidence-based medical therapies for HF as determined by local investigator
* Current pregnancy
* Chronic use of intravenous inotropic medications including milrinone, dobutamine, or dopamine
* eGFR of \<20 mL/min/1.73m2 ongoing chronic dialysis at screening. The eGFR should be estimated using the 2021 Chronic Kidney Disease Epidemiology Collaboration (2021 CKD-EPI) creatinine equation.
* History of prior heart transplant or currently listed for heart transplant
* Current left ventricular assist device or planned left ventricular assist device in the next 6 months
* Currently receiving hospice care
* Chronically resides in an assisted living or skilled nursing facility where medications are managed by facility personnel
* Terminal illness other than HF with a life expectancy of \<1 year as determined by the enrolling clinician-investiga…
What they're measuring
1
Time to all-cause death
Timeframe: Up to 120 days
2
Number of participants with worsening Heart Failure events
Timeframe: Up to 120 days
3
Time to first worsening Heart Failure event
Timeframe: Up to 120 days
4
Change in the number of classes of Heart Failure medications