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New treatment option for Heart Failure With Reduced Ejection Fraction
Official title Lumacaftor Yields Reversal of Impaired Cerebral Blood Flow in Heart Failure Patients
ClinicalTrials.gov ID: NCT07695090
What this study is testing
What is Lumacaftor 200 MG?
Lumacaftor 200 MG is an investigational medicine, being studied as a potential treatment for heart failure with reduced ejection fraction.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants screened for enrolment must meet all of the following criteria to be eligible for study participation:
- Provide written informed consent
- Aged 18 years or older with stable heart failure NYHA class II-III, with reduced cardiac output and an EF of \<40% on optimal goal directed medical...
- No hospital admissions for inpatient care in 3 months prior to study
- CBF at screening of ≤45 mL/100g/min
You likely can't join if
- Participants screened for enrolment, meeting any of the following criteria are not eligible for study participation:
- Participants with symptomatic HF who have non-MRI compatible cardiac implantable electronic devices (CIEDs), such as a cardiac defibrillator or...
- Those requiring coronary revascularisation in 6 months following the study
- Participants with cystic fibrosis (CF) or any other condition that may require use of CFTR modulating agents
- Participants using antiallergics (e.g., montelukast), antibiotics (e.g., clarithromycin), anticoagulants (e.g., warfarin), anticonvulsants (e.g...
- A history of or known seropositivity for human immunodeficiency virus (HIV) and active hepatitis B and/or C infection
See the full eligibility criteria
- Participants screened for enrolment must meet all of the following criteria to be eligible for study participation:
- Provide written informed consent
- Aged 18 years or older with stable heart failure NYHA class II-III, with reduced cardiac output and an EF of \<40% on optimal goal directed medical therapy as per CCS Guidelines and the AHA/ACC/HFSA Guidelines for the...
- No hospital admissions for inpatient care in 3 months prior to study
- CBF at screening of ≤45 mL/100g/min
- Able to comply with study procedures
- Female participants must fulfill at least one of the following:
- Negative serum pregnancy (β-hCG) test at screening if participant is of childbearing potential (defined as having gone through menarche and not postmenopausal)
- Post-menopausal for a minimum of 1 year (defined as 12 consecutive months with no menses without an alternative medical cause) Be surgically sterile for a minimum of 6 months (achieved through partial/total...
- Agree to avoid pregnancy and be willing to use medically acceptable methods of contraception for the duration of study and for 1 month after the last dose of the IMP (for females) and for 3 months after the last dose...
- Participants screened for enrolment, meeting any of the following criteria are not eligible for study participation:
- Participants with symptomatic HF who have non-MRI compatible cardiac implantable electronic devices (CIEDs), such as a cardiac defibrillator or pacemaker, or in whom this is required within 3 months of the study
- Those requiring coronary revascularisation in 6 months following the study
- Participants with cystic fibrosis (CF) or any other condition that may require use of CFTR modulating agents
- Participants using antiallergics (e.g., montelukast), antibiotics (e.g., clarithromycin), anticoagulants (e.g., warfarin), anticonvulsants (e.g., carbamazepine), antidepressants (e.g., citalopram), antifungals (e.g...
- A history of or known seropositivity for human immunodeficiency virus (HIV) and active hepatitis B and/or C infection
- Participants with moderate or severe hepatic disease (such as cirrhosis), or impaired liver function tests defined as serum ALT and/or AST \>3 x the upper limit of normal (ULN) or total bilirubin \>2 x ULN
- Resting heart rate of \>100 bpm
- Symptomatic blood pressure \<90 mmHg systolic
- Any major deviation in clinical lab values and/or electrocardiograms deemed clinically significant at baseline that in the opinion of the investigator would compromise the outcome of the trial as it relates to the...
- Any clinically significant abnormalities in physical examination, neurological examination, vital signs, safety laboratory tests, and/or electrocardiograms that may impact the safety of the participant, in the opinion...
- Any suicidal behaviour in the past 2 years (i.e., actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behaviour), or any suicidal ideation (type 4 or 5) in the last 6 months (i.e., active...
- Participants currently experiencing any clinically significant or unstable medical condition that in the opinion of the investigator might limit their ability to complete the study, or to comply with the requirements of...
- Participants with severe chronic obstructive pulmonary disease (COPD), or demonstrating a significant degree of pulmonary obstruction with a forced expiratory volume in the first second (FEV1) or forced vital capacity...
- Females having used implanted, injected, intravaginal, or intrauterine hormonal contraceptive within 6 months prior to first study drug administration.
- Females taking oral or transdermal hormonal contraceptives within 30 days prior to first study drug administration
- Female participants who are currently breastfeeding or planning to breastfeed
- Any malignancy not considered cured (except basal cell carcinoma of the skin). A participant is considered cured if there has been no evidence of cancer recurrence for the 5 years prior to screening
- Unstable coronary syndromes
- Moderate or severe valvular disease
- Body mass index \>40 kg/m2
- Estimated glomerular filtration rate (eGFR) of \<30 ml/m2
- Participants with a ferro-magnetic aneurysm clip or vascular clamp that is non-MRI compatible
- Claustrophobia or inability to undergo MRI without sedation
- Any other recognized CMRI contraindication as per local guidelines
- Participants that have participated in a clinical study during the 3 months prior to screening, or that plan to participate in another clinical study
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.