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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
Awards & highlights

Re-PHIRE Trial 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.Check my eligibility
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.See study design
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.

Re-PHIRE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in Pulmonary Vascular Resistance (PVR)
Secondary outcome measures
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 outcome measures
Number of participants with adverse events and serious adverse events

Re-PHIRE 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
4,267 Previous Clinical Trials
288,611,978 Total Patients Enrolled
84 Trials studying Heart Failure
165,806 Patients Enrolled for Heart Failure
ParexelIndustry Sponsor
303 Previous Clinical Trials
100,836 Total Patients Enrolled
4 Trials studying Heart Failure
80 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 A, AZD3427 Dose B, AZD3427 Dose C
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial include participants of a younger age demographic?

"The requirements for admission to this trial are patients aged between 18 and 130 years old. There exists 79 studies catering exclusively toward those younger than 18, while 1363 trials address the needs of individuals over 65."

Answered by AI

What is the current enrolment for this clinical research?

"Confirmed. Various details on clinicaltrials.gov suggest that this medical study, initially published on April 24th 2023, is actively looking for participants to enrol in the trial. Across 45 different locations 220 patients are being sought."

Answered by AI

Has the Food and Drug Administration sanctioned the use of AZD3427 Dose A?

"While the efficacy of AZD3427 Dose A is yet to be established, its safety has been investigated and earned a score of 2."

Answered by AI

Are there any open enrollment opportunities for this experiment?

"Affirmative. Sources on clinicaltrials.gov demonstrate that this trial, which first launched on April 24th 2023, is still recruiting participants. 220 volunteers are being sought from 45 different sites for the study."

Answered by AI

How many settings are conducting this research project?

"45 sites are currently participating in this medical trial. These locations, which span from New Haven to Saint Louis, have been carefully chosen so that participants can easily access the nearest one and reduce travel requirements if they choose to enroll."

Answered by AI

What is the participant criteria for this research endeavor?

"This clinical trial is in search of two hundred and twenty individuals aged between 18 to 130 who suffer from pulmonary hypertension. Potential participants must fulfil the following requirements: be of legal age, have a pre-existing heart failure diagnosis (NYHA FC II - IV), possess combined echocardiographic readings that are indicative of intermediate or high probability for PH (ESC/ERS 2022 Guidelines); exhibit an elevated PAWP (>15 mmHg) and mPAP (>20mmHG); have a minimum body weight of 50kg; provide valid consenting documentation."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Trying to help and need money. I was on zebpound for two months I lost 23 pounds for the first time in years my blood pressure was completely normal and I felt great until my insurance would not cover it. Starting my third month. I have been off of it for almost 3 months. I felt horrible again.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study of AZD3427 in Participants With Heart Failure and Pulmonary Hypertension Group 2
2023. "A Study of AZD3427 in Participants With Heart Failure and Pulmonary Hypertension Group 2". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05737940.
All > Pulmonary Hypertension
~90 spots leftby Apr 2025
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