A Study of AZD3427 in Participants With Heart Failure and Pulmonary Hypertension Group 2

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion criteria:

1. Participant must be ≥ 18 years of age inclusive. 2. Participants must have a pre-existing diagnosis of HF, NYHA function class (FC) II to IV, and a pre-existing diagnosis of PH-LHD or likely or intermediate probability of Pulmonary hypertension due to left heart disease (PH-LHD) as per 2022 Pulmonary hypertension due to left heart disease European Society of Cardiology/European Respiratory Society (ESC/ERS) guidelines. Participants must be on stable HF standard of care medication, including diuretics. 3. Participants must have a combination of echocardiographic parameters that show intermediate or high probability of PH as per 2022 ESC/ERS guidelines. 4. Participants must have an on-study elevated pulmonary artery pressure from RHC performed as per RHC manual provided by the Sponsor, at Screening Visit 2: 1. PAWP ≥ 15 mmHg. 2. mPAP ≥ 20 mmHg. 5. Minimum body weight of 45 kg (inclusive). 6. Capable and willing of giving signed informed consent. Exclusion Criteria. 1. Diagnosis of PH in World Health Organization (WHO) Group 1, WHO Group 3, WHO Group 4, or WHO Group 5. 2. Historical or current evidence of a clinically significant disease or disorder. 3. Decompensated HF or hospitalisation due to decompensated HF. 4. Any contraindications to RHC. 5. History of hypersensitivity to SC injections or devices. 6. History of hypersensitivity to drugs with a similar chemical structure or class to AZD3427 or any component of AZD3427 drug product, or ongoing clinically important allergy/hypersensitivity. 7. Known lung disease with Forced expiratory volume in the first second (FEV1) < 30% of predicted. 8. Congenital long QT syndrome. 9. Cardiac ventricular arrhythmia which requires treatment. Participants with atrial fibrillation or flutter and controlled ventricular rate are permitted. 10. History of or anticipated heart transplant or ventricular assist device implantation. 11. Any known planned (scheduled) highly invasive Cardiovascular (CV) procedure (eg, coronary revascularisation, ablation of atrial fibrillation/flutter, valve repair/replacement, aortic aneurysm surgery, etc). 12. Participants who have previously received AZD3427.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05737940
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

AstraZeneca
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Austria, Canada, China, Czechia, Denmark, Germany, Italy, Japan, Netherlands, Poland, Spain, Sweden, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pulmonary Hypertension (World Health Organization Group 2), Heart Failure
Additional Details

This study is a randomized, placebo-controlled, multi-centre, dose-ranging study of AZD3427 in participants with heart failure and pulmonary hypertension due to left heart disease (World Health Organisation [WHO] Group 2). Approximately 220 participants will be randomised to 4 treatment groups (in a 1:1:1:1 ratio) to receive a subcutaneous (SC) injection of AZD3427 or placebo every 2 weeks for 24 weeks. This study will evaluate 3 dose levels of AZD3427: Dose A, Dose B, and Dose C. Dose modification is not applicable for this study. The study will be conducted in approximately 60 study centres across an estimated 15 countries. The study will include approximately 16 study visits: 2 visits during the Screening Period,13 visits during the Treatment Period, and one visit during the Follow-up Period. The expected total duration of the study is 32 to 37 weeks, depending on the length of the Screening Period.

Arms & Interventions

Arms

Experimental: AZD3427 Dose A

The participants will receive single dose of AZD3427 Dose A every 2 weeks for 24 weeks from Day 1 to Day 155.

Experimental: AZD3427 Dose B

The participants will receive single dose of AZD3427 Dose B every 2 weeks for 24 weeks from Day 1 to Day 155.

Experimental: AZD3427 Dose C

The participants will receive single dose of AZD3427 Dose C every 2 weeks for 24 weeks from Day 1 to Day 155.

Placebo Comparator: Placebo

The participants will receive single dose placebo every 2 weeks for 24 weeks from Day 1 to Day 155.

Interventions

Drug: - AZD3427

The participants will receive AZD3427 SC injection single dose of either Dose A or Dose B or Dose C every 2 weeks for 24 weeks.

Drug: - Placebo

The participants will receive SC injection of placebo single dose every 2 weeks for 24 weeks.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Research Site, Beverly Hills, California

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Recruiting

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Research Site

Beverly Hills, California, 90211

Research Site, La Jolla, California

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Recruiting

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Research Site

La Jolla, California, 92093

Research Site, Los Angeles, California

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Not yet recruiting

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Research Site

Los Angeles, California, 90073

Research Site, New Haven, Connecticut

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Recruiting

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Research Site

New Haven, Connecticut, 06519

Research Site, Baltimore, Maryland

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Recruiting

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Research Site

Baltimore, Maryland, 21287

Research Site, Saint Louis, Missouri

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Recruiting

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Research Site

Saint Louis, Missouri, 63136

Research Site, Omaha, Nebraska

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Recruiting

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Research Site

Omaha, Nebraska, 68198

Research Site, Rock Hill, South Carolina

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Recruiting

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Research Site

Rock Hill, South Carolina, 29732

International Sites

Research Site, Eisenstadt, Austria

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Recruiting

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Research Site

Eisenstadt, , 7000

Research Site, Linz, Austria

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Recruiting

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Research Site

Linz, , 4020

Research Site, Wien, Austria

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Recruiting

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Research Site

Wien, , 1100

Research Site, Edmonton, Alberta, Canada

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Recruiting

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Research Site

Edmonton, Alberta, T6G 2E1

Research Site, Vancouver, British Columbia, Canada

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Recruiting

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Research Site

Vancouver, British Columbia, V6Z 1Y6

Research Site, Halifax, Nova Scotia, Canada

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Recruiting

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Research Site

Halifax, Nova Scotia, B3H 3A7

Research Site, London, Ontario, Canada

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Recruiting

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Research Site

London, Ontario, N6A 5A5

Research Site, Ottawa, Ontario, Canada

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Recruiting

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Research Site

Ottawa, Ontario, K1Y 4W7

Research Site, Toronto, Ontario, Canada

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Recruiting

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Research Site

Toronto, Ontario, M5G 2N2

Research Site, Montreal, Quebec, Canada

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Recruiting

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Research Site

Montreal, Quebec, H1T 1C8

Research Site, Beijing, China

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Not yet recruiting

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Research Site

Beijing, , 100034

Research Site, Beijing, China

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Not yet recruiting

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Research Site

Beijing, , 100730

Research Site, Changsha, China

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Recruiting

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Research Site

Changsha, , 430033

Research Site, Guangzhou, China

Status

Recruiting

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Research Site

Guangzhou, , 510100

Research Site, Kunming, China

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Not yet recruiting

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Research Site

Kunming, , 650051

Research Site, Praha 10, Czechia

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Recruiting

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Research Site

Praha 10, , 10034

Research Site, Praha 2, Czechia

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Recruiting

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Research Site

Praha 2, , 12808

Research Site, Praha 4, Czechia

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Recruiting

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Research Site

Praha 4, , 140 21

Research Site, Aarhus, Denmark

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Not yet recruiting

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Research Site

Aarhus, , 8200

Research Site, Copenhagen, Denmark

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Recruiting

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Copenhagen, , 2100

Research Site, Berlin, Germany

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Recruiting

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Research Site

Berlin, , 13353

Research Site, Cologne, Germany

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Not yet recruiting

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Research Site

Cologne, , 50937

Research Site, Frankfurt, Germany

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Recruiting

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Research Site

Frankfurt, , 60596

Research Site, Jena, Germany

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Recruiting

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Research Site

Jena, , 07747

Research Site, Brescia, Italy

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Recruiting

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Research Site

Brescia, , 25123

Research Site, Genoa, Italy

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Recruiting

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Research Site

Genoa, , 16132

Research Site, Marche, Italy

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Recruiting

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Marche, , 60126

Research Site, Milano, Italy

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Recruiting

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Research Site

Milano, , 20142

Research Site, Milan, Italy

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Recruiting

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Milan, , 20138

Research Site, Trieste, Italy

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Recruiting

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Research Site

Trieste, , 34149

Research Site, Kasugai-shi, Japan

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Recruiting

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Research Site

Kasugai-shi, , 487-0016

Research Site, Kure-shi, Japan

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Recruiting

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Research Site

Kure-shi, , 737-8505

Research Site, Matsumoto-shi, Japan

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Recruiting

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Research Site

Matsumoto-shi, , 390-8621

Research Site, Nagoya-shi, Japan

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Recruiting

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Research Site

Nagoya-shi, , 466-8560

Research Site, Okayama, Japan

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Recruiting

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Research Site

Okayama, , 700-8558

Research Site, Sapporo-shi, Japan

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Recruiting

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Research Site

Sapporo-shi, , 060-8648

Research Site, Sunto-gun, Japan

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Recruiting

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Research Site

Sunto-gun, , 411-8611

Research Site, Toyama-shi, Japan

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Recruiting

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Research Site

Toyama-shi, , 930-0194

Research Site, Deventer, Netherlands

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Recruiting

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Research Site

Deventer, , 7416 SE

Research Site, Heerlen, Netherlands

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Recruiting

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Research Site

Heerlen, , 6419 PC

Research Site, Tilburg, Netherlands

Status

Recruiting

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Research Site

Tilburg, , 5022 GC

Research Site, Białystok, Poland

Status

Recruiting

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Research Site

Białystok, , 15-276

Research Site, Gdansk, Poland

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Recruiting

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Research Site

Gdansk, , 80-952

Research Site, Krakow, Poland

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Recruiting

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Krakow, , 31-202

Research Site, Warszawa, Poland

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Recruiting

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Research Site

Warszawa, , 02-005

Research Site, Warszawa, Poland

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Recruiting

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Research Site

Warszawa, , 04-628

Research Site, Wrocław, Poland

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Recruiting

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Research Site

Wrocław, , 50-556

Research Site, Majadahonda, Spain

Status

Recruiting

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Research Site

Majadahonda, , 28222

Research Site, Sevilla, Spain

Status

Recruiting

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Research Site

Sevilla, , 41009

Research Site, Toledo, Spain

Status

Recruiting

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Research Site

Toledo, , 45007

Research Site, Valencia, Spain

Status

Recruiting

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Research Site

Valencia, , 46026

Research Site, Göteborg, Sweden

Status

Recruiting

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Research Site

Göteborg, , 413 45

Research Site, Huddinge, Sweden

Status

Recruiting

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Research Site

Huddinge, , 141 57

Research Site, Cambridge, United Kingdom

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Recruiting

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Research Site

Cambridge, , CB2 0AY

Research Site, Clydebank, United Kingdom

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Recruiting

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Research Site

Clydebank, , G81 4DY

Research Site, London, United Kingdom

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Recruiting

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Research Site

London, , SW3 6NP

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