Lumacaftor Yields Reversal of Impaired Cerebral Blood Flow in Heart Failure Patients (NCT07695090)
A Randomized, Parallel Group, Placebo-controlled, Double-blind, Longitudinal, Single Treatment Center, Phase II Proof-of-concept Study to Evaluate the Efficacy and Safety of Lumacaftor in Stable Heart Failure Subjects With Reduced Ejection Fraction
🩺 Plain-English Summary (8th-Grade Level)
Cognitive impairment (CI) is highly prevalent in patients with heart failure with reduced ejection fraction (HFrEF), which has significant implications for disease management, quality of life and clinical outcomes. Currently, there are no specific treatments for CI aside from the current standard of care therapy for HF, making this a high unmet medical need. Impaired cerebral autoregulation is a proposed mechanistic factor that leads to cerebral hypoperfusion, ischemic damage and the development for CI. Preclinical data indicates that restoring CFTR-protein expression normalizes cerebral microvascular function and cerebral blood flow (CBF) in models of HF. The purpose of this study is to investigate whether CFTR-targeting therapy enhances cerebral perfusion and cognitive function in heart failure patients using the CFTR-corrector Lumacaftor.
Who can join: Review the eligibility criteria below.
Location: St. Michael's Hospital — Toronto, Ontario
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (2 Sites)
- St. Michael's Hospital — Toronto, Ontario
- University Health Network (UHN) Peter Munk Cardiac Centre — Toronto, Ontario
📞 Contact the Study Coordinator
Phone: (877) 308-4220
Email: info@qanatpharma.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Heart Failure With Reduced Ejection Fraction
- Study of JK07 in Patients With Chronic Heart Failure — Alexander City, Alabama
- A Safety and Tolerability Study of HJB647 in Heart Failure Participants With Reduced Ejection Fraction — Bradenton, Florida
- Hemodynamic Assessment of underLying myocyTe Function in Right Heart Failure — Baltimore, Maryland
- PRIME HFrEF: Novel Exercise for Older Patients With Heart Failure With Reduced Ejection Fraction — Charlottesville, Virginia
- Conduction System Vs Surgical Left Ventricular Epicardial Pacing For Coronary Sinus Lead Failure — Overland Park, Kansas
- Synchronized Diaphragmatic Stimulation in Symptomatic Heart Failure — Tulsa, Oklahoma
Explore by condition: All Heart Failure With Reduced Ejection Fraction clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.