• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • Clinical Trial Listings
    • What are Clinical Trials?
    • Become a Clinical Trial Volunteer
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Market Research
    • Benchmark Reports
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
  • White Papers
  • Clinical Trial Listings
  • Advertise
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Biotronik initiates BIOWOMEN study

Biotronik initiates BIOWOMEN study

July 8, 2015
CenterWatch Staff

Biotronik, a manufacturer of cardio- and endovascular medical devices, has enrolled its frist patient in its BIOWOMEN clinical study. BIOWOMEN will investigate cardiac resynchronization therapy (CRT) response in women and men to evaluate if women respond better to treatment. It is the first study of its size to investigate the topic, addressing the urgent medical need for global, gender-specific clinical trials of heart failure (HF) patients.

Dr. María José Sancho-Tello, coordinating clinical investigator, Hospital Universitario La Fe, Valencia, Spain, said, "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."

In order to examine the interrelationship between gender, baseline clinical factors and CRT response, BIOWOMEN will enroll an even ratio of 247 patients of each sex in 25 centers in nine countries worldwide. Enrolment will take place over two years. There will be a one year follow-up, with results expected in 2018. The primary endpoint is response to CRT by measuring the left ventricular ejection fraction. Important secondary endpoints are baseline clinical factors, their relation to response, and QRS-complex related to CRT response.

Usually women are underrepresented in CRT and HF trials, constituting only 25% to 30% of patients enrolled. Nevertheless, relevant CRT trials such as MADIT CRT and CARE-HF have shown that clinical factors favoring CRT response are more present in women than in men, such as non-ischemic cardiomyopathy, hypertension, diabetes and intra-ventricular dyssynchrony.

The current disproportion of female patients in CRT and HF trials is the result of a combination of factors. Co-coordinating clinical investigator of BIOWOMEN, Dr. Lieselot van Erven, LUMC, Leiden, Holland, said, "Women with HF also tend to have more atypical symptoms when compared to men, such as acute ischaemia. This leads to delayed diagnosis and delayed opportunities for CRT in general."

Dr. van Erven said, "This study could contribute to daily clinical decision-making," she added.

According to Albert Panzeri, vice president at Biotronik, providing evidence to support the best clinical care was the driving motive for creating the BIOWOMEN trial. "We understand that ideal treatment for HF patients can vary based on age, sex and medical factors, and the best way to understand the patient population is with clinical investigations," he said. "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."     

    Upcoming Events

    • 05Dec

      Thriving in Clinical Research – Overcoming Common Challenges as a Site: Part 3 – Site Resourcing

    • 14Apr

      MAGI 2024: The Clinical Research Conference

    Featured Products

    • Surviving an FDA GCP Inspection

      Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

    • Best Practices for Clinical Trial Site Management

      Best Practices for Clinical Trial Site Management

    Featured Stories

    • Jonathan Seltzer

      Thought Leadership: Remote Patient Monitoring Gives New View of Safety in Cardiac Clinical Trials

    • Quality_Compass-360x240.png

      Ask the Experts: Applying Quality by Design to Protocols

    • Obesity Treatment Patient

      Clinical Trials Need Greater Representation of Obese Patients, Experts Say

    • Modernize-360x240.png

      FDA IT Modernization Plan Prioritizes Data-Sharing, AI, Collaboration and More

    Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

    The information you need to adapt your monitoring plan to changing times.

    Learn More Here
    • About Us
    • Contact Us
    • Privacy Policy
    • Do Not Sell or Share My Data

    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 703.538.7600 – Toll free 888.838.5578

    Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing