Heart Failure With Reduced Ejection FractionPhase 2LYRIC-HFNCT07695090
Lumacaftor Yields Reversal of Impaired Cerebral Blood Flow in Heart Failure Patients
A Phase 2 study testing Lumacaftor 200 MG in people with Heart Failure With Reduced Ejection Fraction, run by Qanatpharma AG at 2 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction
- What is being tested?
- Lumacaftor 200 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesCanada
- Study dates
- Jul 2026to Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 Management of Heart Failure
- 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
Show all 10Show fewer
- 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 hysterectomy, bilateral oophorectomy, or bilateral salpingectomy; note that tubal ligation is not considered a method of permanent sterilization)
- 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 (for males)
Who cannot join
- 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., fluconazole), anti-mycobacterials (e.g., rifabutin), barbituates, benzodiazepines (e.g., midazolam), immunosuppressants (e.g., cyclosporine), proton pump inhibitors (e.g., esomeprazole) within 30 days of trial start
- A history of or known seropositivity for human immunodeficiency virus (HIV) and active hepatitis B and/or C infection
Show all 26Show fewer
- 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 active therapy
- 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 of the investigator
- 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 suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent), as defined by the C-SSRS
- 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 the protocol, including dermatologic disease, haematological disease, pulmonary disease, kidney disease, hepatic disease, gastrointestinal disease, genitourinary disease, endocrine disease, neurological disease, and psychiatric disease
- 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 (FVC) that is <70% of the predicted normal value, or FEV/FVC ratio that is <65%
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
St. Michael's Hospital
Toronto, Ontario, M5B 1M8
Research Coordinator
Kim Connelly, MD
- Not yet recruiting
University Health Network (UHN) Peter Munk Cardiac Centre
Toronto, Ontario, M5G2N2
Research Coordinator
Filio Billia, MD
About this study
Official title: 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
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.
Read the detailed description
Recent preclinical research has identified wild-type cystic fibrosis transmembrane conductance regulator (CFTR) in cerebral artery smooth muscle cells as a key protein involved in the myogenic mechanism governing cerebrovascular reactivity and a potential therapeutic target. In experimental models of HF, CFTR-protein expression is downregulated, which is associated with increased vascular tone, reduced cerebral blood flow, increased neuronal damage and poorer scores on functional tests. Treatment with CFTR-correctors reverses the pathology and normalizes cerebral artery CFTR-expression, vascular tone, CBF, neuronal health and functional outcome. Lumacaftor is an existing small-molecule CFTR-corrector that increases the abundance of CFTR-protein at the cell membrane by augmenting its trafficking and stability. It is currently approved as part of a combination therapy (lumacaftor/ivacaftor) in cystic fibrosis patients with the CFTR F508del gene mutation.
The purpose of this trial is to build on the CFTR-stabilizing properties of lumacaftor in HF patients and determine whether clinical application of a CFTR-stabilizing treatment improves cerebral perfusion and cognitive performance. The study is a Phase II proof-of-concept, randomized, parallel group, placebo-controlled, double-blind, longitudinal, single treatment center trial of 60 stable adults with HFrEF (no hospitalization within 3 months) on optimal goal-directed medical therapy treated with lumacaftor vs. identical placebo. This will include participants who are New York Heart Association (NYHA) class II-III, with reduced cardiac output and an EF of <40%.
Following eligibility assessment and consent procedures, participants will undergo screening to measure baseline CBF using perfusion-weighted magnetic resonance imaging (MRI). Participants enrolled in the study will be allocated 1:1 to receive lumacaftor 200 mg q12 or identical placebo for 30 days. A follow-up cerebral MRI will assess the change from baseline at 1 month in global CBF as the primary outcome measure of the trial. In additional to safety metrics, a battery of neurocognitive assessments will be administered using the Montreal Cognitive Assessment (MoCA), Trail Making Test (TMT), the Hospital Anxiety and Depression Scale (HADS) and the Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36) to determine changes from baseline, at 1 month and 3 months in cognitive function, mental health, and quality of life as key secondary outcomes.
- Being tested
- Lumacaftor 200 MG, Placebo
- Keywords
- Heart Failure with Reduced Ejection Fraction, Cognitive Impairment, Cerebral Blood Flow, CFTR, Microvascular
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumacaftor 200 MGDrug
Lumacaftor 200 mg q12
PlaceboDrug
Identical placebo
| Study group | Role | What they receive |
|---|---|---|
| Lumacaftor | Experimental | Participants receive 1 tablet of Lumacaftor 200 mg twice daily for 30 days. Receives: Drug: Lumacaftor 200 MG |
| Placebo | Placebo comparator | Participants receive 1 tablet of Lumacaftor placebo tablet twice daily for 30 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of lumacaftor treatment in increasing cerebral blood flow versus placebo in HFrEF patients.
Change from baseline in global cerebral blood flow at 1 month using treatment or placebo as assessed by perfusion weighted MRI.
Measured: Baseline and 1 month
Secondary outcomes (10)
Rate of treatment-emergent adverse events as assessed by MedDRA.
Number of treatment-emergent AEs by severity and treatment received. This will capture participants who received at least one dose of treatment.
Measured: Baseline up to Day 90
Number of participants with clinically significant changes from baseline in physical examinations findings at 1 week, 1 month and 3 months.
Measured: Baseline, 1 week, 1 month and 3 months
Number of participants with clinically significant changes from baseline in vital signs at 1 week, 1 month and 3 months.
Measured: Baseline, 1 week, 1 month and 3 months
Number of participants with clinically significant changes from baseline in electrocardiograms (ECGs) at 1 week, 1 month and 3 months.
Measured: Baseline, 1 week, 1 month and 3 months
Number of participants with clinically significant changes from baseline in laboratory test results at 1 week, 1 month and 3 months.
Measured: Baseline, 1 week, 1 month and 3 months
Number of participants with clinically significant changes from baseline in the Columbia Suicide Severity Rating Scale (C-SSRS) at 1 week, 1 month and 3 months.
The C-SSRS is a questionnaire that captures severity and intensity of suicidal ideation and the number of suicidal behavioural attempts.
Measured: Baseline, 1 week, 1 month and 3 months
Changes from baseline in Montreal Cognitive Assessment (MoCA) scores at 1 month and 3 months.
MoCA is a screening tool for global cognitive function over several domains (memory, attention, language, visuospatial skills, and executive function). Scoring is 0-30-points, with higher scores indicating better global cognition function.
Measured: Baseline, 1 month and 3 months
Changes from baseline in the 36-Item Short Form Health Survey (SF-36) scores at 1 month and 3 months.
The SF-36 is a self-report, general measure of health status and quality of life, assessing eight domains (physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions). Scoring is 0-100 points for each domain, with higher scores indicating a more favourable health state.
Measured: Baseline, 1 month and 3 months
Changes from baseline in the Hospital Anxiety and Depression Scale (HADS) scores at 1 month and 3 months.
HADS is a self-report, 14-item measure to screen for depression and anxiety disorders among non-psychiatric, medically ill, outpatient populations. Scoring is 7 points for each domain of depression and anxiety, with scores of less than 7 for non-cases, 8-10 for mild cases, 11-14 for moderate cases and 15-21 for severe cases.
Measured: Baseline, 1 month and 3 months
Changes from baseline in the Trail-Making-Test (TMT) scores at 1 month and 3 months.
The TMT is an attention and task-switching, two-part test to measure executive and psychomotor function by connecting a series of dots accurately. Scoring is based on time to completion, with a score of more than 70-78 seconds deficient for TMT-A and a score of more than 180-273 seconds deficient for TMT-B.
Measured: Baseline, 1 month and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qanatpharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Qanatpharma Canada LTD
- Responsible party
- Sponsor
- Investigators
- Kim Connelly, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07695090
- Sponsor's protocol ID
- QP586-A01
- Acronym
- LYRIC-HF
- Status last verified
- Jul 2026
- First submitted
- 5 May 2025
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qanatpharma will provide access upon request to individual de-identified participant data reported in the publication beginning 12 months after publication and for up to 36 months following article publication. Data sharing requests can be made by qualified researchers for approved proposals under the terms of a Data Use Agreement. Contact information will be provided at the time of article publication.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07695090
- Acronym / sponsor ID
- LYRIC-HF / QP586-A01
- Keywords
- Heart Failure with Reduced Ejection Fraction, Cognitive Impairment, Cerebral Blood Flow, CFTR, Microvascular
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Qanatpharma AGIndustry (pharma, biotech, devices)
- Collaborators
- Qanatpharma Canada LTD
- Study start
- Jul 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 10 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Recent preclinical research has identified wild-type cystic fibrosis transmembrane conductance regulator (CFTR) in cerebral artery smooth muscle cells as a key protein involved in the myogenic mechanism governing cerebrovascular reactivity and a potential therapeutic target. In experimental models of HF, CFTR-protein expression is downregulated, which is associated with increased vascular tone, reduced cerebral blood flow, increased neuronal damage and poorer scores on functional tests. Treatment with CFTR-correctors reverses the pathology and normalizes cerebral artery CFTR-expression, vascular tone, CBF, neuronal health and functional outcome. Lumacaftor is an existing small-molecule CFTR-corrector that increases the abundance of CFTR-protein at the cell membrane by augmenting its trafficking and stability. It is currently approved as part of a combination therapy (lumacaftor/ivacaftor) in cystic fibrosis patients with the CFTR F508del gene mutation.
The purpose of this trial is to build on the CFTR-stabilizing properties of lumacaftor in HF patients and determine whether clinical application of a CFTR-stabilizing treatment improves cerebral perfusion and cognitive performance. The study is a Phase II proof-of-concept, randomized, parallel group, placebo-controlled, double-blind, longitudinal, single treatment center trial of 60 stable adults with HFrEF (no hospitalization within 3 months) on optimal goal-directed medical therapy treated with lumacaftor vs. identical placebo. This will include participants who are New York Heart Association (NYHA) class II-III, with reduced cardiac output and an EF of <40%.
Following eligibility assessment and consent procedures, participants will undergo screening to measure baseline CBF using perfusion-weighted magnetic resonance imaging (MRI). Participants enrolled in the study will be allocated 1:1 to receive lumacaftor 200 mg q12 or identical placebo for 30 days. A follow-up cerebral MRI will assess the change from baseline at 1 month in global CBF as the primary outcome measure of the trial. In additional to safety metrics, a battery of neurocognitive assessments will be administered using the Montreal Cognitive Assessment (MoCA), Trail Making Test (TMT), the Hospital Anxiety and Depression Scale (HADS) and the Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36) to determine changes from baseline, at 1 month and 3 months in cognitive function, mental health, and quality of life as key secondary outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lumacaftor | Experimental | Drug: Lumacaftor 200 MGParticipants receive 1 tablet of Lumacaftor 200 mg twice daily for 30 days. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants receive 1 tablet of Lumacaftor placebo tablet twice daily for 30 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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 Management of Heart Failure
- No hospital admissions for inpatient care in 3 months prior to study
- CBF at screening of ≤45 mL/100g/min
Key exclusion criteria (26 listed)
- 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., fluconazole), anti-mycobacterials (e.g., rifabutin), barbituates, benzodiazepines (e.g., midazolam), immunosuppressants (e.g., cyclosporine), proton pump inhibitors (e.g., esomeprazole) within 30 days of trial start
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumacaftor 200 MGLumacaftor 200 mg q12 | Drug | Lumacaftor |
| PlaceboIdentical placebo | Drug | Placebo |
Primary outcome
Efficacy of lumacaftor treatment in increasing cerebral blood flow versus placebo in HFrEF patients.
Time frame: Baseline and 1 month
Change from baseline in global cerebral blood flow at 1 month using treatment or placebo as assessed by perfusion weighted MRI.
10 secondary outcomes
Rate of treatment-emergent adverse events as assessed by MedDRA.
Time frame: Baseline up to Day 90
Number of participants with clinically significant changes from baseline in physical examinations findings at 1 week, 1 month and 3 months.
Time frame: Baseline, 1 week, 1 month and 3 months
Number of participants with clinically significant changes from baseline in vital signs at 1 week, 1 month and 3 months.
Time frame: Baseline, 1 week, 1 month and 3 months
Number of participants with clinically significant changes from baseline in electrocardiograms (ECGs) at 1 week, 1 month and 3 months.
Time frame: Baseline, 1 week, 1 month and 3 months
Number of participants with clinically significant changes from baseline in laboratory test results at 1 week, 1 month and 3 months.
Time frame: Baseline, 1 week, 1 month and 3 months
Number of participants with clinically significant changes from baseline in the Columbia Suicide Severity Rating Scale (C-SSRS) at 1 week, 1 month and 3 months.
Time frame: Baseline, 1 week, 1 month and 3 months
Changes from baseline in Montreal Cognitive Assessment (MoCA) scores at 1 month and 3 months.
Time frame: Baseline, 1 month and 3 months
Changes from baseline in the 36-Item Short Form Health Survey (SF-36) scores at 1 month and 3 months.
Time frame: Baseline, 1 month and 3 months
Changes from baseline in the Hospital Anxiety and Depression Scale (HADS) scores at 1 month and 3 months.
Time frame: Baseline, 1 month and 3 months
Changes from baseline in the Trail-Making-Test (TMT) scores at 1 month and 3 months.
Time frame: Baseline, 1 month and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: Yes. Qanatpharma will provide access upon request to individual de-identified participant data reported in the publication beginning 12 months after publication and for up to 36 months following article publication. Data sharing requests can be made by qualified researchers for approved proposals under the terms of a Data Use Agreement. Contact information will be provided at the time of article publication.
Related trials for Heart Failure With Reduced Ejection Fraction
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Recruiting
Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects With Reduced Ejection Fraction
Heart Failure With Reduced Ejection Fraction (HFrEF)
RecruitingObservational study
Descriptive Study of Circulating Gene or Protein Inflammatory Biomarkers and Bioimpedance Parameters in a Population of Patients Hospitalized for Decompensated Heart Failure With Preserved or Mildly Reduced Cardiac Function
Inflammation Biomarkers, Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kim Connelly principal investigator
Unity Health Toronto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lumacaftor 200 MG in people with Heart Failure With Reduced Ejection Fraction, run by Qanatpharma AG at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qanatpharma Clinical Program Manager (1-877-308-4220, info@qanatpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of lumacaftor treatment in increasing cerebral blood flow versus placebo in HFrEF patients. (time frame: Baseline and 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.