Rochester Regional Joins Heart Failure Trials

The health system is enrolling patients in two national clinical studies testing treatments for heart failure with preserved ejection fraction.

Updated on Nov. 6, 2026 in Heart Disease

Bold flat-color editorial illustration of a crimson heart form beside coiled tubing on a navy and cream field, evoking clinical heart research. — Rochester Regional Health has enrolled patients in two national clinical trials testing new treatments for heart failure with preserved ejection fraction. AI Illustration. Upload story photo >

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Rochester Regional Health has joined two national clinical trials investigating treatments for heart failure with preserved ejection fraction (HFpEF). The health system is also enrolling patients for the second part of the LEVEL study.

Why it matters

Specialists turn to research options when patients keep having symptoms despite appropriate, guideline-directed treatment. The trials give patients in the region access to investigational therapies for a condition with limited options.

The LEVEL study is a phase 3 randomized, double-blind, placebo-controlled trial, with about 20 to 30 eligible regional participants in its 12-week part comparing oral levosimendan against placebo. The Rebalance HF first phase divided 90 participants between catheter-based ablation and a sham procedure, and efficacy results have not yet been reported.

The players

Rochester Regional Health

A regional health system based in Rochester, New York, that serves the Finger Lakes and St. Lawrence regions.

The details

The LEVEL study targets patients with HFpEF and pulmonary hypertension, and participants receive either levosimendan or a placebo, with six-minute walking assessments before and after treatment. After 12 weeks, participants initially assigned a placebo also receive levosimendan, and Rochester Regional Health reported the country's second-highest enrollment in the study's first part. The Rebalance HF study evaluates a catheter-based procedure targeting the right greater splanchnic nerve, and its sham group receives a small puncture without the ablation itself.

Nov. 5, 2026: Rochester Regional Health issued its report on the trials.
12 weeks: Duration of the first part of the LEVEL study, after which participants receive levosimendan or placebo.
Late 2028: Projected completion of the LEVEL study, with possible FDA review to follow.
Mid-2029: Projected completion of the Rebalance HF study, followed by possible FDA review.
Two years: Follow-up period for Rebalance HF participants after the procedure.

Health Landscape

The LEVEL study is a phase 3 randomized, double-blind, placebo-controlled trial of oral levosimendan aimed at patients with HFpEF and pulmonary hypertension, a condition with few approved therapies. Rochester's participation adds to the study's national enrollment, which the health system reports ranked second-highest in the first part.

Patients with HFpEF who still have symptoms despite standard treatment may be able to enroll in these trials at Rochester Regional Health. Participation involves randomized assignment to either an investigational therapy or a placebo or sham procedure, with follow-up assessments over weeks or years.

The takeaway

Regional access to clinical trials gives patients with hard-to-treat heart failure an option beyond standard care. Patients interested in enrollment should discuss eligibility with their cardiologist.

What happens next

Rochester Regional Health projects completion of the LEVEL study in late 2028, with possible FDA review to follow about two years later. The Rebalance HF study is projected to finish in mid-2029, followed by possible FDA review.