What is the mechanism of action of this treatment?

Common treatments for Heart Failure (HF) include ACE inhibitors, ARBs, beta blockers, and diuretics. ACE inhibitors and ARBs inhibit the renin-angiotensin system, leading to vasodilation, reduced blood volume, and decreased ventricular filling pressures, which improve cardiac output. Beta blockers reduce heart rate and myocardial oxygen demand, enhancing cardiac efficiency. Diuretics help manage fluid overload, reducing edema and pulmonary congestion. These treatments are crucial for HF patients as they address different aspects of the condition, improving symptoms and outcomes.

What side effects are associated with this type of intervention?

ACE inhibitors, commonly used in heart failure treatment, can cause side effects such as hyperkalemia (elevated potassium levels), hypotension (low blood pressure), and renal dysfunction. Other common treatments for heart failure include beta-blockers, which may lead to bradycardia (slow heart rate) and fatigue, and diuretics, which can cause electrolyte imbalances like hypokalemia (low potassium levels) and dehydration. Calcium channel blockers, another treatment option, may result in peripheral edema (swelling of the extremities) and constipation.

What prior FDA approvals exist?

ACE inhibitors, such as enalapril and lisinopril, have been FDA-approved for the treatment of heart failure due to their ability to reduce ventricular filling pressures and improve cardiac output by inhibiting the angiotensin-converting enzyme, leading to vasodilation and decreased blood volume. Angiotensin II receptor blockers (ARBs) like losartan and valsartan are also approved and offer similar benefits by blocking the effects of angiotensin II. Additionally, beta-blockers such as carvedilol and metoprolol are approved for heart failure treatment, as they help reduce heart rate and myocardial oxygen demand, further improving cardiac function.

What other types of research exist?

Promising alternatives to ACE inhibitors for heart failure patients include Angiotensin Receptor Blockers (ARBs) such as valsartan and candesartan, which block the effects of angiotensin II without increasing bradykinin levels. Additionally, Sacubitril/Valsartan (an ARNI) combines an ARB with a neprilysin inhibitor, offering enhanced benefits by reducing cardiovascular mortality and heart failure hospitalization. Direct renin inhibitors like aliskiren and mineralocorticoid receptor antagonists (MRAs) such as spironolactone and eplerenone are also viable options. These alternatives provide effective management of heart failure by targeting different mechanisms within the RAAS and other related pathways.

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COMPASSION Digital Biomarker for Heart Failure (COMPASSION Trial)

N/A

Recruiting

Led By Zaki Lababidi, MD

Research Sponsored by Aventyn, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to help heart failure patients, especially those who have had a heart attack or have recurring issues, by empowering them with knowledge and using new technologies. The goal is to improve their quality of life and reduce hospital readmissions. By educating patients and monitoring their health with advanced tools, the trial seeks to keep them healthier and out of the hospital.

Who is the study for?

This trial is for men and women over 18 who are hospitalized with acute decompensated heart failure (ADHF) or a recent heart attack (acute myocardial infarction). They must show symptoms like shortness of breath, fatigue, signs of fluid in the lungs, high levels of certain heart-related biomarkers, or reduced heart function.

What is being tested?

The study is testing the COMPASSION Digital Biomarker to see if it can help improve outcomes for patients readmitted to the hospital due to heart failure or after a recent heart attack. The goal is to better coordinate care and possibly reduce future hospital visits.

What are the potential side effects?

Since this trial involves a digital biomarker rather than medication, traditional side effects related to drugs are not applicable. However, there may be privacy concerns regarding personal health data collection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Reducing readmissions

Secondary study objectives

Well-being Self-assessed Likert scale at 30 days from hospitalization

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

Group I: Subjects Testing Positive Covid-19 Antigen TestExperimental Treatment1 Intervention

Phase 2 subjects 50 years or older with positive Covid-19 antigen test and one other risk factor as mentioned in the comorbid section of workflow will be enrolled in this arm of the study. Subjects will be randomized within 48 hours of Covid-19 antigen positive status. Patients will measure their vitals Weight, Sitting BP, Fluid Status, Heart Rate, Respiration Rate each morning for 30 days after discharge. The monitoring of this data of each patient daily will be done by dedicated H2O care team and hospitalist. The hospitalist will coordinate with the patient, the home health team, SNFs and the cardiologists as needed to correct/treat any major abnormalities picked up by the remote monitoring system in order to prevent readmissions. Vitals data collected by the Vitalbeat workbench for biomarker based algorithm variables will be used to drive intervention based on PAP systolic and diastolic pressures.

Group II: Subjects Hospitalized with a Primary Diagnosis of ADHF or Acute MIExperimental Treatment1 Intervention

Phase 1 subjects 18 years or above hospitalized with a primary diagnosis of ADHF or acute MI. Patients will measure their vitals Weight, Sitting BP, Fluid Status, Heart Rate, Respiration Rate each morning for 30 days after discharge. The monitoring of this data of each patient daily will be done by dedicated H2O care team and hospitalist. The hospitalist will coordinate with the patient, the home health team, SNFs and the cardiologists as needed to correct/treat any major abnormalities picked up by the remote monitoring system in order to prevent readmissions. Vitals data collected by the Vitalbeat workbench for biomarker based algorithm variables will be used to drive intervention based on PAP systolic and diastolic pressures.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Heart Failure (HF) include ACE inhibitors, ARBs, beta blockers, and diuretics. ACE inhibitors and ARBs inhibit the renin-angiotensin system, leading to vasodilation, reduced blood volume, and decreased ventricular filling pressures, which improve cardiac output. Beta blockers reduce heart rate and myocardial oxygen demand, enhancing cardiac efficiency. Diuretics help manage fluid overload, reducing edema and pulmonary congestion. These treatments are crucial for HF patients as they address different aspects of the condition, improving symptoms and outcomes.