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HJB647 for Heart Failure with Reduced Ejection Fraction

This study is testing a new medication called HJB647 in people with heart failure where the heart's pumping ability is reduced (Heart Failure with Reduced Ejection Fraction, or HFrEF). Researchers want to see if HJB647 is safe and how well your body handles it at two different doses. A placebo (an inactive capsule that looks like the study drug) will also be used for comparison. You might be able to join if you are 18 or older, have stable heart failure (NYHA functional class II-III), and your heart's pumping ability (LVEF) is less than 50%. Your NT-proBNP levels (a blood test for heart failure) must also meet certain criteria. The main goal is to track any side effects and changes in your vital signs for up to 33 days. The study is currently unclear on its recruitment status and plans to enroll about 12 participants.

Study design
This is a multi-center, randomized, participant- and investigator-blinded, placebo-controlled crossover study involving approximately 12 participants.
What's involved
You will take HJB647 or a placebo for 3 consecutive days while staying at the study site, followed by an in-clinic visit on Day 7 and a safety call on Day 33.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety for up to 33 days after starting treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07465653

A Safety and Tolerability Study of HJB647 in Heart Failure Participants With Reduced Ejection Fraction

Recruiting
PHASE1Ages 18+InterventionalTreatment
Novartis Pharmaceuticals
~12 participants
Updated 2026-09-10 on ClinicalTrials.gov
What's tested:HJB647 low doseHJB647 high dosePlacebo

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with Adverse Events (AEs)
Measured over Up to 33 days
+1 more outcome measured

Conditions

Heart Failure With Reduced Ejection Fraction

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NCT07465653

Where you'd take part

This study runs at 6 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Flourish Research

    Winter Park, Floridastudy coordinator listed

    Recruiting

  • Inpatient Research Clinical LLC

    Miami Lakes, Floridastudy coordinator listed

    Recruiting

  • Jacksonville Center for Clinical

    Jacksonville, Floridastudy coordinator listed

    Recruiting

  • Nature Coast Clinical Research LLC

    Inverness, Floridastudy coordinator listed

    Recruiting

  • Synergy Healthcare

    Bradenton, Floridastudy coordinator listed

    Recruiting

  • Novartis Investigative Site

    Montreal, Quebec, Canadano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Novartis Pharmaceuticals · STUDY_DIRECTOR · Novartis Pharmaceuticals

Who to contact

Novartis Pharmaceuticals
[email protected]
1-888-669-6682
Email the study team

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Eligibility criteria

Inclusion

Men and women aged 18 years or older
Stable NYHA functional class II-III
LVEF \<50%
NT-proBNP ≥600 pg/ml if in sinus rhythm or ≥900 pg/ml if in atrial fibrillation at screening
On stable standard of care therapy with sacubitril/valsartan with a dose of at least 49/51 mg BID for at least 4 weeks before screening.
Acute decompensated heart failure within 3 months prior to screening
SBP \<105 mmHg at screening or baseline.
Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or other major cardiovascular surgery, PCI, or carotid angioplasty within the 6 months prior to screening
Hemodynamically significant mitral and/or aortic valve disease, or any prior valve replacement, except mitral regurgitation secondary to LV dilation at screening
eGFR \<30 ml/min/1.73m2 at screening, as measured by the CKD-EPI formula
BMI \>40 kg/m2
Strong CYP3A4 inhibitors or inducers, sGC activators (vericiguat), PDE5 inhibitors, and nitroglycerin products
Women of childbearing potential

What this trial measures

  • Number of participants with Adverse Events (AEs)Up to 33 days

    Number of participants with AEs as a measure of safety and tolerability

  • Number of participants with clinically significant changes in vital signsUp to 33 days

    Number of participants with clinically significant changes in Systolic Blood Pressure, Diastolic Blood Pressure, Heart Rate, Electrocardiogram and hyposensitive events as a measure of adverse events