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AZD3427 for Heart Failure with Pulmonary Hypertension (Re-PHIRE Trial)
Phase 2
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up on day 15, day 29, day 85, day 127, day 169, and day 211
Summary
This trial studies a drug to treat heart failure and pulmonary hypertension by reducing pulmonary vascular resistance.
Who is the study for?
Adults over 18 with heart failure and pulmonary hypertension group 2, weighing at least 50 kg, on stable heart medications can join. They must have certain echocardiographic signs of PH and elevated artery pressure from a right heart catheterization. Excluded are those allergic to AZD3427 or similar drugs, who've had it before, with other types of PH, significant health issues, planned major heart procedures or severe lung disease.
What is being tested?
The trial is testing AZD3427's effectiveness in reducing lung blood vessel resistance after six months compared to a placebo in patients with both heart failure and pulmonary hypertension group 2. Participants will be randomly assigned to receive either the drug or a placebo.
What are the potential side effects?
Specific side effects for AZD3427 aren't listed but may include reactions related to its chemical class. Common risks could involve allergic reactions or sensitivity where the medication is administered.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ on day 15, day 29, day 85, day 127, day 169, and day 211
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~on day 15, day 29, day 85, day 127, day 169, and day 211
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from baseline in Pulmonary Vascular Resistance (PVR)
Secondary study objectives
Change from baseline in 6-minute walking distance (6MWD)
Change from baseline in Ejection fraction (EF)
Change from baseline in Kansas City Cardiomyopathy Questionnaire total symptom score (KCCQ TSS)
+20 moreOther study objectives
Number of participants with adverse events and serious adverse events
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: AZD3427 Dose CExperimental Treatment1 Intervention
The participants will receive single dose of AZD3427 Dose C every 2 weeks for 24 weeks from Day 1 to Day 155.
Group II: AZD3427 Dose BExperimental Treatment1 Intervention
The participants will receive single dose of AZD3427 Dose B every 2 weeks for 24 weeks from Day 1 to Day 155.
Group III: AZD3427 Dose AExperimental Treatment1 Intervention
The participants will receive single dose of AZD3427 Dose A every 2 weeks for 24 weeks from Day 1 to Day 155.
Group IV: PlaceboPlacebo Group1 Intervention
The participants will receive single dose placebo every 2 weeks for 24 weeks from Day 1 to Day 155.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AZD3427
2020
Completed Phase 1
~110
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,397 Previous Clinical Trials
289,121,463 Total Patients Enrolled
89 Trials studying Heart Failure
173,307 Patients Enrolled for Heart Failure
ParexelIndustry Sponsor
311 Previous Clinical Trials
101,331 Total Patients Enrolled
5 Trials studying Heart Failure
120 Patients Enrolled for Heart Failure
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been hospitalized for heart failure.I have previously taken AZD3427.I have a major heart surgery planned.I have a heart rhythm problem that needs treatment, but atrial issues under control are okay.I have no health issues that prevent me from undergoing a right heart catheterization.I am 18 years old or older.I am willing and able to sign the consent form.My heart ultrasound shows I might have pulmonary hypertension.My condition is classified under WHO Group 1, 3, 4, or 5 pulmonary hypertension.I am on a stable heart failure medication regimen, including water pills.I have a genetic heart condition known as long QT syndrome.I have a serious health condition besides cancer.My lung function is severely reduced, with less than 30% of expected capacity.I have heart failure, am somewhat to very limited in physical activity, and have or likely have PH due to heart disease.My heart's lung arteries have high pressure, confirmed by a special test.My weight is at least 45 kg.I am 18 years old or older.My heart ultrasound shows I likely have pulmonary hypertension.I have heart failure, difficulty with physical activity, and likely have pulmonary hypertension due to heart disease.I am on a stable heart failure medication regimen.My heart's pulmonary artery pressure is high, and I weigh at least 50 kg.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: AZD3427 Dose C
- Group 3: AZD3427 Dose A
- Group 4: AZD3427 Dose B
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.
Heart Failure Patient Testimony for trial: Trial Name: NCT05737940 — Phase 2
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