Biotronik said last week it enrolled the 1st patient in its Biowomen study investigating the difference in cardiac resynchronization therapy response in men and women to understand if women respond better to the treatment.
The trial seeks to enroll 247 patients of each gender over 2 years, with a 1-year follow-up and results expected in 2018, the Berlin, Germany-based medical device company said.
“We understand that ideal treatment for [heart failure] patients can vary based on age, sex and medical factors, and the best way to understand the patient population is with clinical investigations. Through Biowomen we hope to gain insights into the previously unknown question: do women respond better to CRT? If they do, physicians need to know this in order to provide the best care. Providing the best possible patient care is our ultimate goal,” veep Albert Panzeri said in prepared remarks.
Women normally represent up only 25% to 30% of patients enrolled in CRT trials, Biotronik said, even though trials have shown that women have more present clinical factors that favor CRT response.
“I am very excited to begin this groundbreaking trial. Clinical factors linked to CRT response seem to be more present in women when compared to men, but this has not yet been proven. With the proper patient selection, we want to discover if women do indeed respond better to CRT,” coordinating clinical investigator Dr. María Sancho-Tello of Valencia, Spain’s Hospital Universitario La Fe said in a press release.