CLINICAL TRIAL

AZD3427 for Heart Failure

Recruiting · 18+ · All Sexes · Little Rock, AR

This study is evaluating whether a drug may help treat heart failure.

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About the trial for Heart Failure

Treatment Groups

This trial involves 15 different treatments. AZD3427 is the primary treatment being studied. Participants will be divided into 13 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Experimental Group 1
AZD3427
DRUG
Experimental Group 2
AZD3427
DRUG
Experimental Group 3
AZD3427
DRUG
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Eligibility

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Part A will include healthy men and non-pregnant, non-lactating females of non-childbearing potential with a body mass index (BMI) of 18-30 kg/m^2 and a weight of 55-100 kg. One cohort will require participants be of Japanese descent
Participants have a BMI of 18-40 kg/m^2 and a weight of 55-136 kg
Participants with a diagnosis of stage C HF New York Heart Association (NYHA) Class I-III on stable medical therapy for at least 12 weeks
You have been diagnosed with heart failure with reduced ejection fraction. show original
Participants either with N-terminal prohormone of brain natriuretic peptide (NT-proBNP) > 125 pg/mL or BNP > 35 pg/mL (46)
You are a female of non-childbearing potential aged 18 years or older. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Part A: Day 1 (pre-dose, and 10 minutes [only for cohort 5a], 4hrs and 12hrs post-dose, and days 2, 3, 5, 8, 15, 29, and Day 50 or E/T ; Part B: Day 1 (Pre-dose and post-dose), days 8, 15, 22, and 29 (pre-dose); and days 2, 3, 32, 57, 71 and 78 or E/T
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Part A: Day 1 (pre-dose, and 10 minutes [only for cohort 5a], 4hrs and 12hrs post-dose, and days 2, 3, 5, 8, 15, 29, and Day 50 or E/T ; Part B: Day 1 (Pre-dose and post-dose), days 8, 15, 22, and 29 (pre-dose); and days 2, 3, 32, 57, 71 and 78 or E/T.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether AZD3427 will improve 1 primary outcome and 8 secondary outcomes in patients with Heart Failure. Measurement will happen over the course of Part A: Day 1 until Day 50 or Early termination visit (E/T); Part B: Day 1 until Day 78 or E/T.

Number of Participants Experiencing Adverse Events and Serious Adverse Events
PART A: DAY 1 UNTIL DAY 50 OR EARLY TERMINATION VISIT (E/T); PART B: DAY 1 UNTIL DAY 78 OR E/T
Assessment of the safety and tolerability of single and multiple ascending doses of AZD3427.
Evaluation of Positive Anti-drug Antibodies Titer
PART A: DAY 1 (PRE-DOSE), DAYS 15, 29, AND 50 OR E/T; PART B: DAYS 1, 15, 29 (PRE-DOSE), DAYS 57 AND 78 OR E/T
Evaluation of the immunogenicity of single and multiple ascending doses of AZD3427.
Number of Participants Testing Positive for the Presence of Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb) to AZD3427
PART A: DAY 1 (PRE-DOSE), DAYS 15, 29, AND 50 OR E/T; PART B: DAYS 1, 15, 29 (PRE-DOSE), DAYS 57 AND 78 OR E/T
Evaluation of the immunogenicity of single and multiple ascending doses of AZD3427.
Area Under the Serum Concentration-time Curve from Zero to 168 Hours Post-dose Administration (AUC0-168)
PART A: DAY 1 (PRE-DOSE, AND 10 MINUTES [ONLY FOR COHORT 5A], 4HRS AND 12HRS POST-DOSE, AND DAYS 2, 3, 5, 8, 15, 29, AND DAY 50 OR E/T ; PART B: DAY 1 (PRE-DOSE AND POST-DOSE), DAYS 8, 15, 22, AND 29 (PRE-DOSE); AND DAYS 2, 3, 32, 57, 71 AND 78 OR E/T
Evaluation of the PK of single and multiple ascending doses of AZD3427.
Maximum Observed Serum (peak) Drug Concentration (Cmax) of AZD3427
PART A: DAY 1 (PRE-DOSE, AND 10 MINUTES [ONLY FOR COHORT 5A], 4HRS AND 12HRS POST-DOSE, AND DAYS 2, 3, 5, 8, 15, 29, AND DAY 50 OR E/T ; PART B: DAY 1 (PRE-DOSE AND POST-DOSE), DAYS 8, 15, 22, AND 29 (PRE-DOSE); AND DAYS 2, 3, 32, 57, 71 AND 78 OR E/T
Evaluation of the PK of single and multiple ascending doses of AZD3427.
Half-life Associated with Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t½λz)
PART A: DAY 1 (PRE-DOSE, AND 10 MINUTES [ONLY FOR COHORT 5A], 4HRS AND 12HRS POST-DOSE, AND DAYS 2, 3, 5, 8, 15, 29, AND DAY 50 OR E/T ; PART B: DAY 1 (PRE-DOSE AND POST-DOSE), DAYS 8, 15, 22, AND 29 (PRE-DOSE); AND DAYS 2, 3, 32, 57, 71 AND 78 OR E/T
Evaluation of the PK of single and multiple ascending doses of AZD3427.
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Patient Q & A Section

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

Can heart failure be cured?

The majority of patients who have had a heart transplant are still very severely symptomatic and are in need of ongoing treatment. In general there is great hope that with improvements in treatment of heart failure, many of these patients could be living longer, free of a transplant by good treatment of their heart failure.

Anonymous Patient Answer

Does heart failure run in families?

In this group of patients with familial heart failure, there was a higher prevalence of left ventricular hypertrophy but no differences in ejection fraction compared to the control group. This supports the hypothesis that the development of HF does not run in families.

Anonymous Patient Answer

What causes heart failure?

The cause of heart failure is not straightforward and probably involves a combination of factors. Risk factors for worsening heart failure include older age, kidney failure, diabetes and hypertension. The risk of the disease also increases with time since diagnosis. There is a clear need for prevention, with a particular emphasis on reducing smoking.

Anonymous Patient Answer

What are common treatments for heart failure?

Only 3 individuals received ACEI/ARB therapy and only 17 individuals received angiotensin receptor blocker therapy. Overall, the most common treatment for CHF was β-blocker therapy, prescribed to 50-75 percent of the study population. A small percentage of individuals received digoxin.

Anonymous Patient Answer

How many people get heart failure a year in the United States?

Approximately 2.3 million Americans will have heart failure a year. Women are 4.2 times more likely to develop heart failure and are twice as likely as their male counterparts to be hospitalized for heart failure.

Anonymous Patient Answer

What are the signs of heart failure?

What are the clinical signs of heart failure? A 2016 research concluded on the fact that heart failure has no specific symptoms. Heart failure has no specific findings or abnormalities. Nevertheless, heart failure has a set of potential signs and symptoms which can vary depending on many factors that are different for each individual. The research concluded that the signs of heart failure are the clinical picture of heart failure and its severity.

Anonymous Patient Answer

What is heart failure?

HF is a disease of the heart in which the cardiac output is either too weak or can't be increased by the heart muscle. The main result is decreased exercise capacity and increased filling pressure which lead to an increase in left ventricular filling and ventricular wall fatigue. This results in inadequate cardiac output to supply the body's demands for oxygen and nutrients. The reduced cardiac capacity is the result of decreased numbers of cardiac myocytes (satellite cells), the heart's main muscle cells, and inadequate muscle perfusion and oxygen supply. Prostatic cancer may also be associated with heart failure.

Anonymous Patient Answer

Is azd3427 safe for people?

Azd3427 is well tolerated in patients with CHF and is associated with a reduction in body weight (body weight decreased by 3.8% (p = 0.002) and LBM decreased (LBM decreased by 9.4% (p = 0.007). Azd3427 was well tolerated and effective in patients with mild-to-moderate CHF.

Anonymous Patient Answer

Has azd3427 proven to be more effective than a placebo?

The data show that the beneficial effects of azd3427 on quality of life parameters are more pronounced than those in the placebo group, at doses recommended for clinical use. Therefore, they demonstrate its possible benefit in patients with systolic heart failure. However, the benefit of azd3427 seems to be limited. Moreover, the improvement on QoL might be only of little clinical importance to patients. Further studies are needed to clarify whether patients might have expectations.

Anonymous Patient Answer

What is the average age someone gets heart failure?

The mortality rate for heart failure increases with age and the duration of the disease progresses similarly as age. The heart failure in the general public is most commonly present at an older age than the mean survival for patients hospitalized with heart failure.

Anonymous Patient Answer

How does azd3427 work?

The combination of angiotensin 2 receptor blocker with cardiac glycoside is effective in treating heart failure with heart failure symptoms in human clinic and experimental research models.

Anonymous Patient Answer

Have there been other clinical trials involving azd3427?

It is clear that azd3427 has potential as a therapeutic agent for heart failure. As of the time of writing, there is no evidence that any clinical trials involving azd3427 have been completed. However, two of the researchers involved [Professor John W. MacGregor, Mr Peter I. MacIlvaine and Professor Chris Brown] received funding from Pfizer (UK) Ltd. This is likely to be of concern to many researchers. The University of Nottingham and Pfizer (UK) Ltd. provided support and advice for research at the Sir William Dunn School of Pathology and Nottingham Cardiovascular Risk Unit.

Anonymous Patient Answer
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