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Diuretic

Diuretics vs Afterload Reduction for Congestive Heart Failure (DART-HA Trial)

Phase 4

Recruiting

Led By Jay Dinerman, MD

Research Sponsored by Heart Center Research, LLC

Eligibility Criteria Checklist

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

Must have

Lack of standard contraindications to Sacubitril/valsartan: history of ACE-inhibitor induced angioedema and in those with angiotensin II receptor blocker (ARB) therapy induced angioedema, hypotension, hypovolemia, renal artery stenosis, renal failure, hyperkalemia, hepatic disease Child-Pugh class C, Pregnancy/Breast-feeding, Lack of standard contraindications to diuretic therapy, SBP > 105

Be older than 18 years old

Must not have

GFR <25 mL/min who are non-responsive to diuretic therapy or are on chronic renal dialysis

Ongoing symptoms of heart failure decompensation (increased dyspnea and/or fatigue, for purposes of this study increased weight is not considered, see question 2 KCCQ)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30, 60, 90 days

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial is being done to see which treatment options work best for people with congestive heart failure. They will be looking at different treatments like observing the patients, giving them diuretic medicine, or

Who is the study for?

This trial is for people with a Boston Scientific device monitoring heart failure who don't have new symptoms but show diagnostic feature abnormalities. They can't have severe kidney issues, ongoing heart failure symptoms, recent arrhythmia changes, or be pregnant. Stable blood pressure and no history of certain drug reactions are required.

What is being tested?

The DART-HA study compares standard treatments for congestive heart failure: observation alone versus diuretics (like Furosemide) or afterload reducers (like sacubitril/valsartan). It's to see which treatment works best when HeartLogic alerts occur without new symptoms.

What are the potential side effects?

Possible side effects include low blood pressure, dehydration, worsening kidney function, high potassium levels, liver complications from sacubitril/valsartan; and dehydration or electrolyte imbalances from diuretics like Furosemide.

Eligibility Criteria

Inclusion Criteria

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

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I don't have conditions that would make taking Sacubitril/valsartan unsafe for me.

Exclusion Criteria

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

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My kidney function is very low, and water pills don't work for me or I'm on dialysis.

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I am experiencing worsening symptoms of heart failure, such as increased difficulty breathing or fatigue.

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I have severe heart failure symptoms even when resting.

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I receive regular IV treatments for heart failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30, 60, 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30, 60, 90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30, 60, 90 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

Number of participants with recovery from HeartLogic Alert

Secondary study objectives

Number of participants with Heart Failure Events (HFE)

Number of participants with development of symptoms of heart failure decompensation

Number of participants with unintended office visit, emergency department visit, CHF admission

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

3Treatment groups

Active Control

Group I: Observation protocolActive Control1 Intervention

Standard therapy offered until development of symptoms of heart failure decompensation occurs. Patients will be monitored until out of alert and at 30, 60, and 90 days.

Group II: Diuretic protocolActive Control3 Interventions

If asymptomatic at time of HeartLogic(HL) alert, will add or increase diuretic based on current medications. If currently taking ≤ 20 mg. furosemide, begin furosemide 40mg orally daily until recovery from alert or re-alert. If currently taking ≥ 40mg furosemide begin torsemide 20 mg orally daily or bumetanide 1 mg orally daily. If patient unable to obtain torsemide or bumetanide double furosemide daily dose (maximum 480mg daily). If currently taking ≥ 20mg torsemide or ≥ 1mg bumetanide, double daily dose. Recheck HeartLogic index 7 days following initiation of diuretic protocol. If patient recovers from alert consider reducing dose or stopping diuretic. If HeartLogic index is lower but still in alert continue current diuretic dose. If HeartLogic index is the same or higher double diuretic dose and/or add metolazone 2.5mg for 1-2 days.

Group III: Afterload reduction protocolActive Control3 Interventions

If asymptomatic at time of HL alert, increase afterload reduction drugs based on current medications. If on Sacubitril/valsartan, double the dose. If on maximum Sacubitril/valsartan, add Hydralazine 10mg and Isordil10 mg both three times a day. If on Angiotensin Receptor Blocker (ARB) at low dose (less than or equal to Valsartan 160mg daily or equivalent) then stop ARB and start sacubitril/valsartan 24-26mg twice a day. If on ARB at high dose (greater than Valsartan 160mg daily or equivalent) then immediately stop ARB and start Sacubitril/valsartan 49-51mg twice a day. If on Angiotensin-converting enzyme (ACE) inhibitor at low dose (less than or equal to 10mg daily or equivalent) then immediately stop ACE inhibitor and start Sacubitril/valsartan 24-26mg twice a day after 48hours. If on ACE inhibitor at high dose (greater than Enalapril 10mg daily or equivalent) stop ACE inhibitor and start Sacubitril/valsartan 49-51mg twice a day after 48hours. Cut diuretic in half for all.

0 / 5Eligibility criteria met