Phase 2 Clinical Trial for Pulmonary Hypertension has Officially Begun

About Pulmonary Hypertension

Pulmonary Hypertension (PH) is a form of high blood pressure which affects the arteries. Primary Pulmonary Hypertension refers to a type of the condition whose origin is unknown. Secondary Pulmonary Hypertension is typically a result of a previous disease or underlying condition.

PH is progressive and can cause dyspnea, heart palpitations, chest pain, fatigue, dizziness, and swelling of the ankles or legs. There has yet to be a cure discovered for the condition, let alone a standard treatment regime. But, Tenax Therapeutics has hope that their ongoing Phase 2 clinical trial will provide positive results for a new therapy for this patient population. It’s called the HELP trial.

The HELP Trial

The HELP Trial stands for Hemodynamic Evaluation of Levosimendan in Patients with PH-HFpEF. What the heck is PH-HFpEF you may wonder? This acronym refers to Pulmonary Hypertension and Heart Failure with preserved Ejection Fraction which is the specific group of PH patients Tenax is evaluating in this study.

This trial will investigate levosimendan’s hemodynamic benefits for PH-HFpEF patients in comparison to placebo. Levosimendan is a calcium sensitizer. It currently has approval in more than 60 countries as a treatment for heart failure. Over 1 million patients across these nations have been treated with the drug. The positive outcomes recorded from these patients, in addition to preclinical data and clinical studies for PH, have indicated the drug has promise for PH-HFpEF.

HELP will include 36 patients who will be treated at 10-12 clinical trial sites across the United States. The first of these patients has just enrolled. Tenax has stated that they expect more trial sites to begin enrollment within the next few weeks.

Hopefully we will see positive results from this Phase 2 trial released in the future. It could ultimately lead to the development of an effective treatment regime for this patient population with a high unmet need.

You can read more about the HELP trial here.


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