Could Your Patient Benefit form the MAGMA, MAGMA Add-On or EXHALTED Studies?

UH Clinical Update - October 2017

Researchers at University Hospitals Harrington Heart & Vascular Institute are seeking participants for three important clinical research projects.

The MAGMA (Mineralocorticoid Receptor Antagonism Clinical Evaluation in Atherosclerosis) trial, funded to investigators at UH and Case Western Reserve University School of Medicine by the National Institutes of Health, is a multicenter trial that seeks to determine whether the diuretic spironolactone (Aldactone) slows the worsening of atherosclerosis, reduces blood pressure and reduces inflammation. The MAGMA-Add-On study is an open label study of patiromer (Veltassa) that will test the same hypothesis, except that it will include patients who develop hyperkalemia on spironolactone or RAAS blockers (and therefore cannot take the latter agents). They will be given the potassium-binding drug patiromer to facilitate use of spironolactone without causing hyperkalemia.

Participants in MAGMA must have Type 2 diabetes, be at least 45 years old and have decreased kidney function. They will take spironolactone or a placebo and will attend eight clinic visits at UH Cleveland Medical Center as part of MAGMA. Participants who complete the entire study will receive paid parking and a $240 stipend. Criteria in MAGMA-Add-On are similar, except that patients will receive open label patiromer in conjunction with spironolactone.

The EXHALTED (Exercise MRI Evaluation of HIV-MRI Longitudinal Determinants) study is using UH’s new exercise MRI system to study cardiopulmonary responses and pulmonary arterial hypertension (PAH) in patients with HIV. PAH in HIV is an important cause of morbidity and mortality and is thought to have the worst prognosis of any subtype of PAH. The results from this study may allow early identification of right heart disease and answer questions about heart and lung responses with exercise in HIV patients.

Participants in the EXHALTED trial must meet the following criteria:

• Confirmed HIV
• Age 18 to 65
• Plan to remain in the local area for the next two years
• Unexplained persistent or progressively worsened dyspnea for at least six weeks OR previously documented sPAP>35 mmHg and/or abnormal RV on echo OR an established diagnosis of HIV-PAH
• Karnofsky score >70 on at least one occasion within past two weeks prior to entry

If you have a patient who could benefit from one of these studies, please contact Study Nurse Steve Sawicki, RN, at 216-844-7188 or Steven.Sawicki@UHhospitals.org.