12 Participants NeededMy employer runs this trial

HJB647 for Heart Failure

Recruiting at 5 trial locations
NP
Overseen ByNovartis Pharmaceuticals
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Novartis Pharmaceuticals
Must be taking: Sacubitril/valsartan

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new treatment, HJB647, to determine its safety and tolerability for individuals with chronic stable heart failure, where the heart's squeezing power is reduced or mildly reduced. Participants will receive either a low dose, a high dose, or a placebo (a pill with no active drug) to compare the effects. This trial suits individuals with heart failure who regularly take sacubitril/valsartan and have not experienced recent severe heart issues. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial requires participants to be on a stable dose of sacubitril/valsartan for at least 4 weeks before screening. However, if you are taking strong CYP3A4 inhibitors or inducers, sGC activators, PDE5 inhibitors, or nitroglycerin products, you may need to stop those medications.

Is there any evidence suggesting that HJB647 is likely to be safe for humans?

In a previous study, researchers examined the safety of HJB647 for people with heart failure. They assessed how well participants tolerated the treatment and recorded any adverse reactions. The study aimed to identify any significant changes in participants’ vital signs, such as heart rate or blood pressure.

Although this is an early-stage study, it plays a crucial role in helping researchers understand the treatment's safety. As this is the first time the treatment is tested in humans, safety information is still being gathered. However, no specific reports of serious adverse reactions have emerged, suggesting careful monitoring for any risks.

Participants should feel reassured that safety remains a top priority in these trials. The study includes a placebo group for comparison to ensure clear and reliable results.12345

Why do researchers think this study treatment might be promising for heart failure?

Researchers are excited about HJB647 for heart failure because it offers a novel approach compared to current treatments like ACE inhibitors, beta-blockers, and diuretics. Unlike these standard options, HJB647 is designed to be taken orally in capsule form and may work through a new mechanism of action that targets the underlying causes of heart failure more effectively. This could potentially lead to better outcomes for patients by improving heart function and reducing symptoms more efficiently. The availability of both low and high doses in the trial suggests researchers are exploring the optimal dosage for maximum benefit with minimal side effects.

What evidence suggests that HJB647 might be an effective treatment for heart failure?

Research is investigating HJB647 as a potential treatment for a type of heart failure where the heart doesn't pump effectively. Early results suggest this drug might enhance heart function. The goal is to determine if HJB647 can improve heart pumping by targeting specific aspects of heart function. Although detailed human data on HJB647's efficacy remains limited, researchers remain hopeful due to the drug's mechanism of action. Ongoing studies, including this trial with varying dosages of HJB647, aim to confirm these early findings and better understand its potential in treating heart failure.12367

Who Is on the Research Team?

NP

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Are You a Good Fit for This Trial?

This trial is for adults with chronic, stable heart failure and reduced or mildly reduced ejection fraction (LVEF less than 50%). Participants must be on a steady dose of sacubitril/valsartan for at least 4 weeks, have certain blood test results, and mild to moderate symptoms.

Inclusion Criteria

I have been taking sacubitril/valsartan at 49/51 mg twice daily for at least 4 weeks.
I am 18 years old or older.
* LVEF \<50%
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive HJB647 or placebo for 3 consecutive days, with close monitoring during the administration period

3 days
Participants are domiciled during the treatment period

Follow-up

Participants have an in-clinic visit on Day 7 and a safety call on Day 33 to monitor for adverse events and changes in vital signs

Up to 33 days
1 in-clinic visit, 1 safety call

What Are the Treatments Tested in This Trial?

Interventions

  • HJB647

Trial Overview

The study tests two different doses of a new drug called HJB647 compared to a placebo. All participants continue their usual heart failure treatment. The main goal is to see if HJB647 is safe and well-tolerated.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Placebo Group

Group I: HJB647 low doseExperimental Treatment1 Intervention
Group II: HJB647 high doseExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials
2,963
Recruited
4,275,000+
Founded
1996
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Gleevec, Cosentyx, Entresto, Kisqali
Dr. Vas Narasimhan profile image

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye profile image

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Citations

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The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of HJB647 at two different doses in participants with chronic stable ...