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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 weeks
Treatment ~ Varies
Follow Up ~on day 15, day 29, day 85, day 127, day 169, and day 211
This trial's timeline: 3 weeks for screening, Varies for treatment, and on day 15, day 29, day 85, day 127, day 169, and day 211 for reporting.

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 more
Other 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
4,402 Previous Clinical Trials
289,123,713 Total Patients Enrolled
90 Trials studying Heart Failure
173,507 Patients Enrolled for Heart Failure
ParexelIndustry Sponsor
312 Previous Clinical Trials
101,355 Total Patients Enrolled
5 Trials studying Heart Failure
120 Patients Enrolled for Heart Failure

Media Library

AZD3427 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05737940 — Phase 2
Heart Failure Research Study Groups: Placebo, AZD3427 Dose C, AZD3427 Dose A, AZD3427 Dose B
Heart Failure Clinical Trial 2023: AZD3427 Highlights & Side Effects. Trial Name: NCT05737940 — Phase 2
AZD3427 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05737940 — Phase 2
Heart Failure Patient Testimony for trial: Trial Name: NCT05737940 — Phase 2
~48 spots leftby Apr 2025