Actively Recruiting

Phase 1
Age: 18Years - 100Years
All Genders
NCT07465653

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

Led by Novartis Pharmaceuticals · Updated on 2026-04-15

12

Participants Needed

3

Research Sites

27 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of HJB647 at two different doses in participants with chronic stable heart failure with reduced or mildly reduced ejection fraction (HFrEF/HFmrEF).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women aged 18 years or older
  • Stable NYHA functional class II-III
  • Left ventricular ejection fraction less than 50%
  • NT-proBNP 600 pg/ml or higher if in sinus rhythm, or 900 pg/ml or higher if in atrial fibrillation at screening
  • On stable standard of care therapy with sacubitril/valsartan at a dose of at least 49/51 mg twice daily for at least 4 weeks before screening
Not Eligible

You will not qualify if you...

  • Acute decompensated heart failure within 3 months prior to screening
  • Systolic blood pressure less than 105 mmHg at screening or baseline
  • Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or other major cardiovascular surgery, percutaneous coronary intervention, or carotid angioplasty within 6 months prior to screening
  • Hemodynamically significant mitral and/or aortic valve disease, or any prior valve replacement, except mitral regurgitation secondary to left ventricular dilation at screening
  • Estimated glomerular filtration rate less than 45 ml/min/1.73m2 at screening
  • Body mass index greater than 40 kg/m2
  • Use of strong CYP3A4 inhibitors or inducers, sGC activators (vericiguat), PDE5 inhibitors, and nitroglycerin products
  • Women of childbearing potential

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Synergy Healthcare

Bradenton, Florida, United States, 34208

Actively Recruiting

2

Nature Coast Clinical Research LLC

Inverness, Florida, United States, 34452

Actively Recruiting

3

Jacksonville Center for Clinical

Jacksonville, Florida, United States, 32216

Actively Recruiting

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Research Team

N

Novartis Pharmaceuticals

CONTACT

N

Novartis Pharmaceuticals

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

3

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