~30 spots leftby Jul 2025

AZD3427 for Heart Failure with Pulmonary Hypertension

(Re-PHIRE Trial)

Recruiting at63 trial locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: AstraZeneca
Prior Safety Data

Trial Summary

What is the purpose of this trial?

This study is intended to assess the ability of AZD3427 to reduce pulmonary vascular resistance (PVR) after 24 weeks of treatment in participants with heart failure (HF) and pulmonary hypertension (PH) Group 2

Do I have to stop taking my current medications for this trial?

The trial does not specify if you need to stop taking your current medications. However, participants must be on stable heart failure standard of care medication, including diuretics, to be eligible.

What data supports the idea that AZD3427 for Heart Failure with Pulmonary Hypertension is an effective drug?

The available research does not provide specific data on AZD3427 for Heart Failure with Pulmonary Hypertension. However, it mentions other treatments like pulmonary vasodilators, which are used for similar conditions. In patients with severe pulmonary hypertension due to lung disease, these treatments did not improve walking distance or functional class, but they did reduce a marker in the blood that indicates heart stress. This suggests that while there might be some benefits, the effectiveness of such treatments can vary depending on the specific type of lung disease. Further study is needed to determine if these treatments can slow disease progression.12345

What safety data is available for AZD3427 in heart failure with pulmonary hypertension?

The provided research does not contain any safety data for AZD3427 or its variants (AZD-3427, azd 3427, azd3427) in the context of heart failure with pulmonary hypertension. The studies focus on other treatments like selexipag, sodium nitrite, ambrisentan, and sitaxsentan for pulmonary hypertension.678910

Is the drug AZD3427 a promising treatment for heart failure with pulmonary hypertension?

Yes, AZD3427 is a promising drug for heart failure with pulmonary hypertension because similar drugs have shown benefits like improving symptoms, heart function, and exercise ability in patients with pulmonary hypertension.411121314

Research Team

Eligibility Criteria

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.

Inclusion Criteria

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.
See 4 more

Exclusion Criteria

History of hypersensitivity to SC injections or devices
I have been hospitalized for heart failure.
I have previously taken AZD3427.
See 9 more

Treatment Details

Interventions

  • AZD3427 (Other)
Trial OverviewThe 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.
Participant Groups
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 of placebo every 2 weeks for 24 weeks from Day 1 to Day 155.

Find a Clinic Near You

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Parexel

Industry Sponsor

Trials
322
Recruited
137,000+
Peyton Howell profile image

Peyton Howell

Parexel

Chief Executive Officer

Master of Healthcare Administration from The Ohio State University, Bachelor of Arts in Health Communications from the University of Illinois

Dr. Austin Smith profile image

Dr. Austin Smith

Parexel

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland

Findings from Research

In a study comparing 118 patients with severe pulmonary hypertension (PH) due to lung disease to 74 patients with idiopathic pulmonary arterial hypertension (IPAH), those with lung disease were older and had worse overall health, leading to poorer survival rates, particularly among those with interstitial lung disease (ILD).
While treatment with pulmonary vasodilators did not improve walking distance or functional class in patients with severe PH and lung disease, it did result in a significant decrease in NT-proBNP levels, suggesting some benefit, though further research is needed to determine if these therapies can slow disease progression.
Severe pulmonary hypertension in lung disease: phenotypes and response to treatment.Brewis, MJ., Church, AC., Johnson, MK., et al.[2015]
In a study involving 64 patients with pulmonary arterial hypertension (PAH), ambrisentan significantly improved exercise capacity, as measured by a 36.1 meter increase in the 6-minute walk distance after 12 weeks, with consistent benefits across all tested doses (1, 2.5, 5, and 10 mg).
The treatment also led to improvements in symptoms and hemodynamics, including reduced pulmonary arterial pressure and increased cardiac index, while showing a low incidence of mild adverse events, indicating a favorable safety profile.
Ambrisentan therapy for pulmonary arterial hypertension.Galié, N., Badesch, D., Oudiz, R., et al.[2023]
In a study of 44 patients with pulmonary hypertension and heart failure, intravenous levosimendan did not significantly reduce exercise-PCWP after 6 weeks, but it did lower PCWP across all exercise stages, indicating some hemodynamic benefits.
Levosimendan treatment led to a significant improvement in the 6-minute walk distance (6MWD) by 29.3 meters compared to placebo, suggesting it may enhance exercise capacity in these patients.
Levosimendan Improves Hemodynamics and Exercise Tolerance in PH-HFpEF: Results of the Randomized Placebo-Controlled HELP Trial.Burkhoff, D., Borlaug, BA., Shah, SJ., et al.[2022]

References

Severe pulmonary hypertension in lung disease: phenotypes and response to treatment. [2015]
Ambrisentan therapy for pulmonary arterial hypertension. [2023]
Levosimendan Improves Hemodynamics and Exercise Tolerance in PH-HFpEF: Results of the Randomized Placebo-Controlled HELP Trial. [2022]
Selective pulmonary vasodilatory effect of ZSY-27 in dogs with pulmonary hypertension due to pulmonary embolism. [2019]
[Efficacy and safety of ambrisentan therapy in Chinese patients with pulmonary hypertension]. [2016]
Selexipag for the treatment of children with pulmonary arterial hypertension: First multicenter experience in drug safety and efficacy. [2021]
Real-world practice patterns and characteristics of adverse events with selexipag in Korean patients with pulmonary arterial hypertension. [2022]
Acute hemodynamic effects of inhaled sodium nitrite in pulmonary hypertension associated with heart failure with preserved ejection fraction. [2023]
Evaluation of efficacy, safety and tolerability of Ambrisentan in Chinese adults with pulmonary arterial hypertension: a prospective open label cohort study. [2018]
10.United Statespubmed.ncbi.nlm.nih.gov
Sitaxsentan for the treatment of pulmonary arterial hypertension: a 1-year, prospective, open-label observation of outcome and survival. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Pulmonary vasodilation in acute and chronic heart failure: empiricism and evidence. [2021]
Upfront triple combination therapy in pulmonary arterial hypertension: a pilot study. [2018]
13.United Statespubmed.ncbi.nlm.nih.gov
Combination Therapy of Pulmonary Arterial Hypertension with Vardenafil and Macitentan Assessed in a Human Ex Vivo Model. [2020]
The pulmonary physician in critical care. 13: the pulmonary circulation and right ventricular failure in the ITU. [2020]