HJB647 safety and tolerability in people with heart failure and reduced ejection fraction.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, participant- and investigator-blinded, placebo-controlled crossover Phase 1 trial enrolling about 12 adults with chronic stable HFrEF or HFmrEF who are on stable sacubitril/valsartan therapy. Participants are randomized 1:1:1 to one of three three-day treatment sequences that include a low dose of HJB647, a high dose of HJB647, and placebo, with domiciling for close monitoring during dosing. The study collects safety, tolerability, and pharmacokinetic data, with an in-clinic follow-up on Day 7 and a safety call on Day 33. The primary goal is to characterize safety and drug levels rather than clinical efficacy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Participants eligible for inclusion in this study must meet all of the following criteria:

* 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 for at least 4 weeks before screening.

Exclusion Criteria:

Participants will be deemed ineligible for inclusion if they meet any of the following exclusion criteria:

* 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

Further eligibility criteria might apply in alignment with the trial protocol.

Where it's running

• Synergy Healthcare
  Bradenton, Florida, United States Recruiting
• Nature Coast Clinical Research LLC
  Inverness, Florida, United States Recruiting
• Jacksonville Center for Clinical
  Jacksonville, Florida, United States Recruiting
• Inpatient Research Clinical LLC
  Miami Lakes, Florida, United States Recruiting
• Flourish Research
  Winter Park, Florida, United States Recruiting
• Novartis Investigative Site
  Montreal, Quebec, Canada Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: 1-888-669-6682

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Yoga-based cardiac rehabilitation for heart failure with reduced ejection fraction

  This trial tests whether a yoga-based rehabilitation program can help people with heart failure and reduced ejection fraction compared with an educational program.

  Recruiting at 12 sites Centre for Chronic Disease Control, India · Dharwad, Karnataka and 15 other locations · NCT07817589

• Lumacaftor to improve cerebral blood flow in heart failure with reduced ejection fraction

  This study tests whether lumacaftor can improve brain blood flow and thinking abilities in adults with a certain type of heart failure.

  Recruiting Phase 2 Qanatpharma AG · Toronto, Ontario and 1 other locations · NCT07695090

• Stepwise withdrawal of ARNI and SGLT2i in HF with normalized ejection fraction

  This trial tests whether gradually stopping ARNI and SGLT2i is safe for people whose heart function has recovered after fixing a reversible heart‑disease cause.

  Recruiting Phase 4 Keimyung University Dongsan Medical Center · Daegu, Daegu and 4 other locations · NCT07631156

• Ring-style blood pressure bracelet test compared with 24-hour monitoring in people with HFrEF

  A ring-type blood pressure device is being tested to see if its 24-hour readings match those from standard ambulatory monitoring in adults with heart failure and reduced ejection fraction.

  Recruiting Keimyung University Dongsan Medical Center · Daegu · NCT07626879

• Diet and exercise plan to help people with heart failure and preserved heart function.

  This study tests whether a DASH-style, high-protein diet, resistance exercise, or both can help build muscle and improve fitness and quality of life in people with heart failure and reduced ejection fraction.

  Recruiting Medical University of Silesia · Zabrze, Silesian Voivodeship · NCT07595809

• HFrEF polypill strategy in Sri Lanka

  This study tests whether giving a heart failure polypill can reduce death from heart disease and hospitalizations in adults with HFrEF in Sri Lanka, compared with usual care.

  Recruiting at 10 sites Phase 3 Washington University School of Medicine · Kandy, Central Province and 11 other locations · NCT07569640

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.