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Diuretic

Diuretic protocol 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30, 60, 90 days
Awards & highlights

DART-HA Trial 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.Check my eligibility
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.See study design
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.

DART-HA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I don't have conditions that would make taking Sacubitril/valsartan unsafe for me.

DART-HA Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with recovery from HeartLogic Alert
Secondary outcome measures
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

DART-HA 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.

Find a Location

Who is running the clinical trial?

Heart Center Research, LLCLead Sponsor
Boston Scientific CorporationIndustry Sponsor
720 Previous Clinical Trials
932,942 Total Patients Enrolled
Jay Dinerman, MDPrincipal InvestigatorHeart Center Research, LLC

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the diuretic treatment plan received official endorsement from the FDA?

"Given that the Diuretic protocol is being evaluated in a Phase 4 trial, signifying its approval for use, our team at Power rates its safety as a 3 on the scale."

Answered by AI

Is the trial currently accepting new participants?

"Indeed, as indicated on clinicaltrials.gov, this trial is actively seeking individuals to participate. It was initially posted on July 8th, 2021 and the most recent update occurred on January 11th, 2024."

Answered by AI

What is the upper limit of participants involved in this medical study?

"Indeed, the information available on clinicaltrials.gov indicates that this research endeavor is actively seeking eligible participants. The trial was initially posted on July 8th, 2021 and underwent its most recent update on January 11th, 2024. Researchers aim to recruit a total of 80 patients from a single designated site."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts
2021. "Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06218199.
All > Entresto > Congestive Heart Failure
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