Asking Questions Giving Options
August 17, 2016
New clinical trials open for advanced LV heart failure, chelation therapy and renal denervation for treatment-resistant hypertension
At University Hospitals Harrington Heart & Vascular Institute, patients with cardiovascular disease have access to more than 90 clinical trials. Here are some details about three leading-edge trials under way here:
Momentum 3: This trial is comparing a next-generation left ventricular assist device (LVAD), HeartMate 3, with its predecessor, HeartMate 2, both as a bridge to heart transplantation and as destination therapy for patients with advanced refractory left ventricular heart failure. Investigators are determining whether the new device offers comparable survival and quality of life benefits as the older device, as well as whether the new, smaller device may reduce adverse events.
HeartMate 3 received CE Mark approval in Europe in October 2015. It uses magnetic levitation, allowing the device’s rotor to be suspended by magnetic forces.This design aims to reduce trauma to blood passing through the pump, reduce friction and “wear-andtear” on the rotor and improve outcomes for patients. HeartMate 3 also provides pulsatility.
Heart failure specialist Guilherme Oliveira, MD, Director, Advanced Haert Failure & Transplant Center, and Director, Onco-Cardiology Program, UH Harrington Heart & Vascular Institute and Clinical Assistant Professor of Medicine, Case Western Reserve University School of Medicine and cardiac surgeon Benjamin Medalion, MD, are leading the Momentum 3 trial at UH.
“I think HeartMate 3 is going to be a significantly better device, with less infection and less thrombosis,” Dr. Oliveira says. “It has no bearing, so it’s less thrombogenic and therefore likely safer. It has pulsatility, which we think will be beneficial to patients. Overall, I believe that this device will result in longer event-free survival compared with HeartMate 2.”
TACT 2: In 2013, the Trial to Access Chelation Therapy (TACT) 1 study showed a striking decline in recurrent cardiovascular events among post-MI diabetic patients, with results published in JAMA. Now, investigators on the TACT 2 study are seeking to replicate these findings among this high-risk population.
“The first TACT trial showed a modest benefit for all post-MI patients, but among diabetic subjects, a substantial improvement in survival free of recurrent heart disease was observed. This was a big surprise and has prompted a follow-up trial to validate these findings,” says interventional cardiologist David A. Zidar, MD, PhD, Director, Famililial Dyslipidemial/LDL Apheresis Clinic, UH Harrington Heart & Vascular Institute, Center and Assistant Professor of Medicine, Case Western Reserve University School of Medicine who is leading the TACT 2 trial at UH.
Patients eligible for the TACT 2 trial include people with diabetes, age 50 or older, who’ve had a prior MI. They’re randomly assigned to one of four groups: active chelation plus twice-daily high-dose oral multivitamins and multiminerals (OMVM); active chelation plus oral placebo; placebo chelation plus OMVM; and placebo chelation plus oral placebo. Chelation therapy (or placebo) sessions occur weekly for 40 weeks.
“This study could have significant ramifications for people with diabetes,” Dr. Zidar says. “Chelation is well-tolerated, but it is done weekly, so it does become a substantial commitment on the part of patients. And the design will also show us whether vitamins are an essential part of chelation therapy.”
RADIANCE-HTN trial: Methodological problems with the SYMPLICITY HTN-3 trial made the results difficult to interpret. Although the trial showed no differences between the catheterbased renal denervation and a sham procedure in addressing treatment-resistant hypertension, differing hypertension drug regimens and medication compliance rates confounded the results. The new RADIANCE-HTN trial aims to clear up these issues – potentially opening a new treatment avenue for millions of people with treatment-resistant hypertension.
Interventional cardiologist Sahil Parikh, MD, is leading the RADIANCE-HTN trial at UH, along with UH hypertension authority Jackson Wright, MD, PhD.
The new RADIANCE-HTN trial has two arms: Patients in the solo cohort are included if their hypertension is such that they can safely discontinue their hypertension medications for a short time. Patients with resistant hypertension are enrolled in the trio cohort. They discontinue their individual hypertension regimens and instead receive a single, three-medicine pill once a day. Both groups are randomly assigned to the denervation procedure with a new, ultrasound-based device, or to a renal angiogram “sham” procedure.
“The FDA has had a strong hand in designing this and other renal denervation trials, and we’re better positioned to get the answers we need,” Dr. Parikh says. “Treatment-resistant hypertension is an incredibly important problem. For carefully selected patients, this trial gives them options.”
If you have a patient whom you believe would benefit from any of these clinical trials, please contact Stacey Mazzurco, BSN, RN, CCRP, Director, Clinical Trials, at 216-844-3130 or Stacey.Mazzurco@UHhospitals.org.