Rochester Patients Gain Access to Heart Trials

Adults with heart failure that keeps stiffening the heart's chamber can now enroll locally in two national studies.

Updated on Nov. 6, 2026 in Heart Disease

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Rochester Regional Health has enrolled local adults with heart failure that stiffens the heart's chamber into two national clinical trials, including a study of levosimendan. AI Illustration. Upload story photo >

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Rochester Regional Health has joined two national clinical trials testing treatments for heart failure with preserved ejection fraction (HFpEF), a form of heart failure in which the heart's pumping chamber still contracts normally but stiffens and does not fill well. The health system reported the enrollment on Nov. 5, 2026, and is still recruiting patients for the second part of the LEVEL study for people with HFpEF and pulmonary hypertension.

Why it matters

Patients with HFpEF who keep having symptoms despite guideline-directed treatment have limited options, and clinical trials offer access to treatments still under study. Rochester Regional Health's participation brings those trials closer to patients across the region.

The LEVEL study is a phase 3, randomized, double-blind, placebo-controlled trial of oral levosimendan in patients with HFpEF and pulmonary hypertension, with participants assessed by six-minute walk tests before and after 12 weeks of treatment. The Rebalance HF first phase randomized 90 participants to catheter-based ablation of the right greater splanchnic nerve or a sham procedure, and no outcome results have yet been released.

The players

Rochester Regional Health

A Rochester-based health system that is enrolling patients in both the LEVEL and Rebalance HF trials for heart failure treatment.

The details

Levosimendan is a drug that is being studied for its effect on the heart's pumping and relaxation function. In the LEVEL study, participants receive either levosimendan or a placebo for 12 weeks, after which those initially given the placebo also receive levosimendan. The Rebalance HF study uses a catheter-based procedure that targets the right greater splanchnic nerve, which is intended to reduce the strain on the heart; participants in the sham group undergo a small puncture without the ablation itself. Participants in the Rebalance HF study are assessed before and after the procedure and followed for two years.

Timeline

  1. Nov. 5, 2026: Rochester Regional Health issued its report on the trials.

  2. The LEVEL study's first part lasts 12 weeks, after which participants who received the placebo are also given levosimendan.

  3. Rochester Regional Health projects completion of the LEVEL study in late 2028.

  4. Rochester Regional Health projects completion of the Rebalance HF study in mid-2029.

  5. Participants in the Rebalance HF study are followed for two years after the procedure.

Health Landscape

Heart failure with preserved ejection fraction has historically had fewer proven treatment options than heart failure with reduced ejection fraction, which is why ongoing trials of new drugs and procedures are closely watched. These two studies test different approaches, one pharmacologic and one procedural, for a population that still faces persistent symptoms.

If you have been diagnosed with heart failure and still have symptoms despite your current treatment, it is worth asking your cardiologist whether clinical trials such as these might be appropriate for you. Trial participation is a decision to make together with your physician, who can weigh eligibility and whether it fits your care plan.

The takeaway

Clinical trials are one route for people with HFpEF whose symptoms persist despite standard treatment, and Rochester Regional Health is among the sites enrolling. Patients interested in learning more should discuss eligibility and options with their cardiologist.

What happens next

Rochester Regional Health projects completion of the LEVEL study in late 2028 and the Rebalance HF study in mid-2029, each followed by possible FDA review.

Further reading

For broader background on the condition at the center of these trials, explore Heart Disease coverage.

Source note: This article includes information reported by Fingerlakes1.

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