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Mineralocorticoid Receptor Antagonist

Baxdrostat + Dapagliflozin for Heart Failure (Prevent-HF Trial)

Phase 3

Waitlist Available

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

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

Must have

Participants must be ≥ 40 years old at the time of signing the informed consent

Diagnosed with T2DM and requiring treatment

Must not have

Concomitant therapy with strong inducers of cytochrome P450

Established heart failure diagnosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up event driven; up to 38 months

Awards & highlights

Pivotal Trial

Summary

This trial is looking for men and women over 40 years old with Type 2 Diabetes, heart disease, high blood pressure, and other risk factors for heart failure. Participants will go through a pre

Who is the study for?

This trial is for men and women over 40 with type 2 diabetes, cardiovascular disease, high blood pressure (SBP ≥130 mmHg), a specific potassium level in their blood, and at least one other risk factor for heart failure. They must not have been treated with SGLT2 inhibitors or only have had such treatment for less than four weeks.

What is being tested?

The study tests Baxdrostat combined with Dapagliflozin against a placebo paired with Dapagliflozin to see which is better at preventing heart failure and cardiovascular death. Participants will be randomly assigned to either group and followed up regularly after taking the medication.

What are the potential side effects?

Possible side effects may include changes in blood pressure, kidney function issues due to dapagliflozin, potential electrolyte imbalances from Baxdrostat, as well as general risks like dizziness or dehydration.

Eligibility Criteria

Inclusion Criteria

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

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I am 40 years old or older.

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I have type 2 diabetes and need treatment.

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I have a history of heart or blood vessel disease.

Exclusion Criteria

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

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I am not taking medication that strongly activates liver enzymes.

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I have been diagnosed with heart failure.

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I have not had a heart attack in the last 3 months.

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I have not had dialysis in the last 3 months.

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I have had or am planning to have an organ or bone marrow transplant.

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My kidney function is low, with an eGFR below 30.

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I had a procedure to open blocked arteries in my heart within the last month.

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I have severe liver problems (Child-Pugh Class C).

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I have been diagnosed with adrenal insufficiency.

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I have type 1 diabetes or my type 2 diabetes is not under control with an HbA1c over 10.5%.

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I have not had a stroke, heart surgery, or related procedures in the last 3 months.

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I am currently taking medications that help my body retain potassium or control my blood pressure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ event driven; up to 38 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~event driven; up to 38 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and event driven; up to 38 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

To determine if baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of an HF event or CV death

Secondary study objectives

To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of CV death

To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of HF events

To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of MI or CV death

+4 more

Awards & Highlights

Pivotal Trial

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Placebo/DapagliflozinExperimental Treatment1 Intervention

Patients will receive a dose of dapagliflozin in combination with matching placebo

Group II: Baxdrostat/DapagliflozinExperimental Treatment1 Intervention

Participants randomised to the baxdrostat/dapagliflozin arm will initially receive a dose of baxdrostat lower dose and dapagliflozin. For participants that meet the up-titration criteria, baxdrostat may be up-titrated to higher dose.

0 / 15Eligibility criteria met