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Jtt-861 Monohydrochloride Dihydrate

This article discusses a Phase 2a clinical trial investigating the use of JTT-861 Monohydrochloride Dihydrate in patients with heart failure with reduced ejection fraction (HFrEF). The study aims to evaluate the efficacy, safety, and tolerability of JTT-861 when administered for 12 weeks. This multicenter, randomized, double-blind, placebo-controlled trial involves approximately 300 participants and compares two different doses of JTT-861 against a placebo.

Table of Contents

Overview of JTT-861

JTT-861 MONOHYDROCHLORIDE DIHYDRATE, also known simply as JTT-861, is a new medication being studied for the treatment of heart failure with reduced ejection fraction (HFrEF). This condition occurs when the heart’s ability to pump blood is weakened, leading to various symptoms and complications.[1]

How JTT-861 Works

While the exact mechanism of JTT-861 is not explicitly stated in the provided information, it is being investigated as a potential treatment for HFrEF. The drug is being tested to see if it can improve various aspects of heart function and quality of life for patients with this condition.[1]

Current Clinical Trial: POWER-HF Study

JTT-861 is currently being evaluated in a clinical trial called POWER-HF (Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study). This study aims to assess the efficacy, safety, and tolerability of JTT-861 when administered for 12 weeks in patients with HFrEF.[1]

Who Can Participate in the Study?

The study is looking for participants who meet specific criteria, including:

  • Men or women aged 30-85 years
  • Diagnosed with symptomatic heart failure for at least 90 days
  • In New York Heart Association (NYHA) functional class II or III (This classification system categorizes the severity of heart failure symptoms)
  • On stable, guideline-directed therapy for heart failure for at least 4 weeks
  • Have a left ventricular ejection fraction (LVEF) of 35% or less (LVEF is a measure of how well the heart pumps blood)
  • Have elevated levels of a hormone called N-terminal pro b-type natriuretic peptide (NT-pro-BNP), which is often increased in heart failure

There are also several conditions that would exclude someone from participating, such as recent heart attacks, certain heart surgeries, or severe kidney problems.[1]

Study Design and Treatment

The POWER-HF study is designed as follows:

  • Approximately 300 participants will be involved
  • Participants will be randomly assigned to one of three groups:
    1. JTT-861 50 mg once daily
    2. JTT-861 100 mg once daily
    3. Placebo (a pill with no active ingredient) once daily
  • The treatment period lasts for 12 weeks
  • Neither the participants nor the doctors will know which treatment each person is receiving (this is called “double-blind” and helps ensure unbiased results)
  • Participants will visit the clinical site at weeks 2, 4, 8, and 12 during the treatment period
  • A follow-up visit will occur about 4 weeks after the last dose of the study drug

This design allows researchers to compare the effects of different doses of JTT-861 against a placebo and assess its safety and effectiveness.[1]

What Will Be Measured?

The study will assess various aspects of heart function and overall health, including:

  • Echocardiography measurements: These ultrasound tests will look at how well the heart is pumping and its size
  • Blood tests: Including NT-pro-BNP levels and other markers of heart and kidney function
  • Quality of life: Using a questionnaire called the Kansas City Cardiomyopathy Questionnaire (KCCQ)
  • Safety parameters: Monitoring for any side effects or changes in vital signs
  • Pharmacokinetics: Measuring the levels of JTT-861 in the blood to understand how the body processes the drug

These measurements will help researchers understand how JTT-861 affects the heart and overall health of patients with HFrEF.[1]

Potential Benefits and Considerations

While the potential benefits of JTT-861 are still being investigated, the study aims to determine if the drug can:

  • Improve heart function
  • Reduce symptoms of heart failure
  • Enhance quality of life for patients with HFrEF

It’s important to note that as this is a clinical trial, the effectiveness and safety of JTT-861 are not yet fully established. Participants in the study will be closely monitored for any potential side effects or adverse reactions.[1]

If successful, JTT-861 could potentially offer a new treatment option for patients with heart failure with reduced ejection fraction, a condition that significantly impacts many people’s lives.

Aspect Details
Study Type Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group
Drug JTT-861 Monohydrochloride Dihydrate
Condition Heart Failure with Reduced Ejection Fraction (HFrEF)
Duration 12-week treatment period + 4-week follow-up
Participants Approximately 300
Treatment Groups JTT-861 50 mg, JTT-861 100 mg, Placebo (1:1:1 ratio)
Key Inclusion Criteria Age 30-85, HF diagnosis ≥90 days, NYHA class II or III, LVEF ≤35%, Elevated NT-pro-BNP
Primary Outcomes Changes in LVEF, Left ventricular volumes, NT-pro-BNP, Quality of life scores
Safety Assessments Adverse events, Laboratory tests, Vital signs, ECG parameters

FAQ

  • What is the main purpose of this clinical trial? The main purpose of this clinical trial is to evaluate the efficacy, safety, and tolerability of JTT-861 Monohydrochloride Dihydrate when administered for 12 weeks in patients with heart failure with reduced ejection fraction (HFrEF).
  • Who can participate in this study? Participants must be between 30-85 years old, have a clinical diagnosis of symptomatic heart failure for at least 90 days, be in New York Heart Association (NYHA) functional class II or III, have a left ventricular ejection fraction (LVEF) of 35% or less, and meet specific NT-pro-BNP level criteria.
  • How long does the trial last? The trial consists of a 12-week treatment period, followed by a follow-up visit approximately 4 weeks after the last dose of the study drug.
  • What are the treatment groups in this study? There are three treatment groups: JTT-861 50 mg once daily, JTT-861 100 mg once daily, and a placebo group. Participants are randomly assigned to one of these groups in a 1:1:1 ratio.
  • What are the main outcomes being measured in this trial? The main outcomes include changes in left ventricular ejection fraction (LVEF), left ventricular volumes, NT-pro-BNP levels, quality of life scores, and safety parameters such as adverse events and changes in laboratory values, vital signs, and ECG parameters.

Ongoing Clinical Trials on Jtt-861 Monohydrochloride Dihydrate

  • Study on JTT-861 for Patients with Heart Failure with Reduced Ejection Fraction

    Recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Czechia Poland Romania Spain

Glossary

  • Heart Failure with Reduced Ejection Fraction (HFrEF): A type of heart failure where the heart's ability to pump blood is reduced, typically defined as having a left ventricular ejection fraction of 40% or less.
  • Left Ventricular Ejection Fraction (LVEF): The percentage of blood that is pumped out of the left ventricle of the heart with each contraction. It is a key measure of heart function.
  • NT-pro-BNP: N-terminal pro b-type natriuretic peptide, a hormone released by the heart in response to stress. Elevated levels can indicate heart failure.
  • New York Heart Association (NYHA) Functional Class: A classification system for heart failure that categorizes patients based on their symptoms and physical limitations, ranging from Class I (no symptoms) to Class IV (severe symptoms).
  • Echocardiography (2D-echo): An imaging technique that uses sound waves to create pictures of the heart, allowing doctors to assess heart structure and function.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Adverse Events (AEs): Any unfavorable and unintended sign, symptom, or disease that occurs during a clinical trial, whether or not it is related to the treatment being studied.
  • Randomized, Double-blind, Placebo-controlled: A study design where participants are randomly assigned to treatment groups, neither the participants nor the researchers know who is receiving the actual treatment or placebo, and a placebo group is included for comparison.

References

  1. http://clinicaltrials.eu/trial/study-on-jtt-861-for-patients-with-heart-failure-with-reduced-ejection-fraction/