What side effects are associated with this type of intervention?

Common treatments for heart failure include ACE inhibitors, beta-blockers, diuretics, and mineralocorticoid receptor antagonists. ACE inhibitors can cause cough, elevated blood potassium levels, and kidney dysfunction. Beta-blockers may lead to fatigue, bradycardia, and dizziness. Diuretics often result in electrolyte imbalances, dehydration, and kidney dysfunction. Mineralocorticoid receptor antagonists can cause hyperkalemia and gynecomastia. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

The FDA has approved several guideline-directed medical therapies for the treatment of heart failure. These include ACE inhibitors like enalapril, beta-blockers such as metoprolol and carvedilol, and ARBs like losartan. Additionally, mineralocorticoid receptor antagonists such as spironolactone have been approved. More recently, newer therapies like the angiotensin receptor-neprilysin inhibitor (ARNI) sacubitril/valsartan and the SGLT2 inhibitors dapagliflozin and empagliflozin have also received FDA approval for heart failure treatment. These medications are designed to improve symptoms, reduce hospitalizations, and increase survival rates in heart failure patients.

What other types of research exist?

Promising novel alternatives to remote care strategies for heart failure patients in 2024 include: 1) Advanced telemedicine platforms that integrate AI for personalized treatment recommendations and real-time monitoring. 2) Wearable technology for continuous health monitoring and early detection of heart failure exacerbations. 3) Pharmacogenomics to tailor medication regimens based on genetic profiles. 4) Multidisciplinary care teams utilizing coordinated care models to enhance patient outcomes. 5) Digital therapeutics that provide interactive, patient-specific interventions to improve adherence and lifestyle modifications.

← Back to Search

ARNI

Optimal Heart Failure Therapy for Heart Failure (COPILOT-HF Trial)

Q: What is the mechanism of action of this treatment?

Common treatments for heart failure with reduced ejection fraction (HFrEF) include diuretics, which reduce fluid overload and alleviate symptoms like edema and dyspnea by promoting urine production. Angiotensin system blockers (such as ACE inhibitors, ARBs, and ARNI) lower blood pressure and reduce strain on the heart by inhibiting pathways that cause vasoconstriction and fluid retention. Beta blockers slow the heart rate and decrease myocardial oxygen demand, improving heart function over time. Mineralocorticoid receptor antagonists help prevent fibrosis and further fluid retention. Sodium-glucose co-transporter 2 inhibitors, originally used for diabetes, have been shown to reduce heart failure hospitalizations and cardiovascular death by promoting diuresis and reducing cardiac workload. These treatments are essential for managing heart failure as they target different mechanisms contributing to disease progression, thereby improving symptoms, reducing hospitalizations, and enhancing overall survival.

Phase 4

Recruiting

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

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

Must have

Documented diagnosis of heart failure (e.g., ICD-9 codes 428 ICD-10 codes I50 or Problem list in the electronic health record)

Be older than 18 years old

Must not have

eGFR<30 mL/min/1.73m2

Current severe aortic stenosis or severe aortic insufficiency

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-months following randomization

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial is testing two remote care methods to improve medication plans for heart failure patients. One method uses a virtual clinic with a step-by-step approach, and the other focuses on education and remote management. The goal is to find out which method helps doctors prescribe the best medications.

Who is the study for?

This trial is for heart failure patients who have seen a Mass General Brigham provider in the last 2 years, with an EF assessment in the past 24 months, and speak English or Spanish. It's not for those with severe blood pressure issues, certain heart diseases like amyloidosis or pulmonary hypertension, very low kidney function, active chemotherapy treatment, end-of-life care recipients, transplant-related cases or those on specific heart support treatments.

What is being tested?

The COPILOT-HF trial tests two remote care strategies to optimize prescriptions of guideline-directed medical therapies (like SGLT2i inhibitors and ARNI) for heart failure patients. The study randomly assigns participants to different treatment approaches and monitors them remotely within the healthcare system.

What are the potential side effects?

Potential side effects from medications such as SGLT2 inhibitors may include urinary infections or dehydration; beta blockers can cause fatigue or dizziness; ARNIs might lead to kidney problems or angioedema; MRAs could increase potassium levels which affects heart rhythm.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with heart failure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My kidney function is severely reduced.

Select...

I have a severe narrowing or leakage of the aortic valve in my heart.

Select...

My heart pumps well and I am either on SGLT2 inhibitors or cannot tolerate them.

Select...

I have been diagnosed with amyloidosis affecting my heart.

Select...

I am currently undergoing chemotherapy.

Select...

I have had a transplant or am being considered for one.

Select...

I am on medication for Group 1 pulmonary arterial hypertension.

Select...

My heart's pumping ability is below 50%, and I can't tolerate heart failure medications ARNi and SGLT2i.

Select...

I am receiving heart medication through an IV at home.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-months following randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-months following randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-months following randomization for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Primary Endpoint

Secondary study objectives

Secondary Endpoint

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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: Medication & Education-FirstExperimental Treatment1 Intervention

Patient will immediately begin participation in a remote, pharmacist-driven heart failure clinic that will initiate and titrate medications according to a standardized medical algorithm.

Group II: Education-FirstActive Control2 Interventions

Patient will first receive curated patient education, an alert to providers, and provider education, and then after 3 months begin participation in the remote heart failure clinic.

0 / 10Eligibility criteria met

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 with reduced ejection fraction (HFrEF) include diuretics, which reduce fluid overload and alleviate symptoms like edema and dyspnea by promoting urine production. Angiotensin system blockers (such as ACE inhibitors, ARBs, and ARNI) lower blood pressure and reduce strain on the heart by inhibiting pathways that cause vasoconstriction and fluid retention. Beta blockers slow the heart rate and decrease myocardial oxygen demand, improving heart function over time. Mineralocorticoid receptor antagonists help prevent fibrosis and further fluid retention. Sodium-glucose co-transporter 2 inhibitors, originally used for diabetes, have been shown to reduce heart failure hospitalizations and cardiovascular death by promoting diuresis and reducing cardiac workload. These treatments are essential for managing heart failure as they target different mechanisms contributing to disease progression, thereby improving symptoms, reducing hospitalizations, and enhancing overall survival.