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Apabetalone for Pulmonary Arterial Hypertension (APPROACH-2 Trial)
Phase 2
Waitlist Available
Led By Steeve Provencher, MD, MSc
Research Sponsored by Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
PAH of idiopathic/hereditary/drug or toxin-induced origin; or associated with connective tissue diseases or simple congenital heart disease (atrial septal defect, ventricular septal defect, patent ductus arteriosus) corrected for >1 year
WHO functional class II or III
Must not have
Other types of pulmonary hypertension (Simonneau, Montani et al. 2019), including pulmonary related to left heart diseases, lung diseases, chronic thromboembolic disease or multifactorial mechanisms (PH groups 2-5, respectively)
Significant restrictive (total lung capacity <70% predicted) or obstructive (FEV1/FVC<60% after a bronchodilator) lung disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 8 and week 24
Summary
This trial tests a new pill that may help reduce the severity of Pulmonary Arterial Hypertension (PAH) and improve heart and lung function in adults who are already on stable treatment.
Who is the study for?
Adults aged 18-75 with Pulmonary Arterial Hypertension (PAH) who are stable on current PAH medication for at least 3 months can join. They must be able to walk at least 150 meters and have a life expectancy of more than 28 weeks. Participants need normal organ function, not be pregnant or breastfeeding, and agree to use contraception if necessary.
What is being tested?
The trial is testing the effectiveness of Apabetalone as an additional treatment for PAH over a period of 24 weeks. It will compare changes in pulmonary vascular resistance (PVR) between those taking Apabetalone and those given a placebo while continuing their usual PAH therapy.
What are the potential side effects?
While specific side effects for this trial aren't listed, common ones from similar medications include headache, dizziness, nausea, diarrhea, rash or swelling where the drug enters the body. More serious risks could involve liver problems or blood cell count changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My pulmonary arterial hypertension is due to genetics, drugs, toxins, or related to a heart defect that was corrected over a year ago.
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My heart or lung condition mildly or moderately affects my daily activities.
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My blood, liver, and kidney functions are within normal ranges.
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I can walk 150 meters or more without stopping.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My pulmonary hypertension is not caused by left heart diseases, lung diseases, chronic blood clots, or multiple factors.
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I have severe lung disease that affects my breathing.
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I am not currently using strong medication inhibitors or have stopped them for 2 weeks.
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I have not had major surgery in the last 2 weeks or have fully recovered from it.
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I might have a rare lung blood vessel disorder.
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My pulmonary arterial hypertension is due to HIV or liver issues.
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I am unable to give consent by myself.
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I haven't had a whole blood transfusion in the last 4 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 8 and week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 8 and week 24
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Placebo-corrected change from baseline in PVR at week 24
Secondary study objectives
Change at week 24 in HRQoL assessed using the EmPHasis-10 questionnaire
Change at week 24 in mean Pulmonary Artery Pressure (mPAP), mmHg obtained from right heart catheterization
Change in cardiac output (L/min)
+5 moreOther study objectives
Change in PBMC expression of BMPR2
Change in clinical worsening events
Circulating levels change in whole blood markers of DNA damage
+3 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: ApabetaloneActive Control1 Intervention
100mg BID, 24-week (168±3 days) Treatment Period.
Group II: PlaceboPlacebo Group1 Intervention
24-week (168±3 days) period.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Pulmonary Arterial Hypertension (PAH) include endothelin receptor antagonists (ERAs), phosphodiesterase-5 inhibitors (PDE5Is), and prostacyclin analogs. ERAs, such as bosentan and ambrisentan, work by blocking endothelin-1, a potent vasoconstrictor, thereby reducing pulmonary vascular resistance and improving blood flow.
PDE5Is, like sildenafil and tadalafil, enhance nitric oxide signaling, leading to vasodilation and improved exercise capacity. Prostacyclin analogs, such as epoprostenol and iloprost, mimic the effects of prostacyclin, promoting vasodilation and inhibiting platelet aggregation.
Emerging treatments like Apabetalone, a BRD4 inhibitor, target epigenetic regulation and have shown promise in reversing disease progression in animal models. These mechanisms are crucial for PAH patients as they address the underlying vascular dysfunction, improve hemodynamics, and potentially enhance long-term outcomes.
Find a Location
Who is running the clinical trial?
Resverlogix CorpIndustry Sponsor
12 Previous Clinical Trials
3,581 Total Patients Enrolled
1 Trials studying Pulmonary Arterial Hypertension
7 Patients Enrolled for Pulmonary Arterial Hypertension
Institut universitaire de cardiologie et de pneumologie de Québec, University LavalLead Sponsor
22 Previous Clinical Trials
4,171 Total Patients Enrolled
Laval UniversityLead Sponsor
427 Previous Clinical Trials
174,812 Total Patients Enrolled
6 Trials studying Pulmonary Arterial Hypertension
108 Patients Enrolled for Pulmonary Arterial Hypertension
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your body mass index (BMI) is between 18 and 40.My pulmonary arterial hypertension is due to genetics, drugs, toxins, or related to a heart defect that was corrected over a year ago.I am postmenopausal, sterilized, using contraception, or not engaging in activities that could lead to pregnancy.If you can have a baby, you need to have a negative pregnancy test before starting the treatment.My heart or lung condition mildly or moderately affects my daily activities.I am between 18 and 75 years old, or up to 80 if I have scleroderma-related PAH.Your doctor thinks you may not live for more than 1 year because of other health issues.My pulmonary hypertension is not caused by left heart diseases, lung diseases, chronic blood clots, or multiple factors.My blood, liver, and kidney functions are within normal ranges.I have severe lung disease that affects my breathing.I have 3 or more risk factors for heart failure, such as being overweight, having diabetes, high blood pressure, heart disease, recent cancer or infection.I will use a condom and ensure my partner uses contraception during and for 3 months after my treatment.You are allergic to apabetalone or any of its ingredients.I am not currently using strong medication inhibitors or have stopped them for 2 weeks.Your heart rate when you are awake and resting is either lower than 50 beats per minute or higher than 110 beats per minute.I have not had major surgery in the last 2 weeks or have fully recovered from it.I started taking bosentan less than 6 months ago.Tests show that you have blood clots in your lungs.I might have a rare lung blood vessel disorder.My pulmonary arterial hypertension is due to HIV or liver issues.Your lung function is less than 40%.Your blood pressure is lower than 90 mmHg when your heart beats.My heart medication has been the same and stable for over 3 months.I can walk 150 meters or more without stopping.I am unable to give consent by myself.You are expected to live for at least 28 weeks.I was hospitalized for acute right ventricle failure within the last 30 days.Your pulmonary artery pressure is too high, and there is no immediate way to improve it.I have started or plan to start a heart and lung rehab program within the last 12 weeks.I haven't had a whole blood transfusion in the last 4 months.
Research Study Groups:
This trial has the following groups:- Group 1: Apabetalone
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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