Clinical trial NCT06017609: Evaluate Efficacy, Safety and Tolerability of JTT-861 in Subjects With Heart Failure With Reduced Ejection Fraction
Official title: A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety and Tolerability of JTT-861 Administered for 12 Weeks in Subjects With Heart Failure With Reduced Ejection Fraction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Chronic Heart Failure
Keywords: JTT-861
Efficacy
Safety
Tolerability
Chronic Heart Failure
HFrEF
Heart Failure
Lead sponsor: Akros Pharma Inc.
Sponsor class: INDUSTRY
Collaborators: name: ICON Clinical Research
First posted: 2023-08-30
Enrollment: 300
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy, safety, tolerability and pharmacokinetics of JTT-861 administered once daily for 12 weeks in subjects with heart failure with reduced ejection fraction (HFrEF) who are on a stable, guideline-directed medical therapy for heart failure.


Eligibility criteria: Inclusion Criteria:

* Has a clinical diagnosis of symptomatic heart failure (HF) ≥90 days prior to the Screening Visit;
* Is in New York Heart Association (NYHA) functional class II or III at the Screening Visit;
* Is on stable, guideline-directed therapy for HF, consistent with American Heart Association (AHA), American College of Cardiology (ACC), Heart Failure Society of America (HFSA) or European Society of Cardiology (ESC) guidelines for ≥4 weeks prior to the Screening Visit (with at least half of maximal labeled dose of renin-angiotensin-aldosterone system (RAAS) inhibitors and β-blockers, if tolerated);
* Has left ventricular ejection fraction (LVEF) ≤35% at the Screening Visit;
* Has a serum N-terminal pro b-type natriuretic peptide (NT-pro-BNP) level ≥600 pg/mL (or ≥900 pg/mL if the subject has atrial fibrillation or atrial flutter) at the Screening Visit.

Exclusion Criteria:

* Has a confirmed acute myocardial infarction (MI) (i.e., Type 1) or unstable angina within 90 days prior to the Screening Visit;
* Has a history of coronary revascularization (percutaneous coronary intervention \[PCI\] and/or coronary artery bypass graft \[CABG\]) or other cardiovascular surgery within 90 days prior to the Screening Visit or planned cardiovascular surgery during the study through the Follow-up Visit);
* Has started cardiac resynchronization therapy (CRT) within 90 days prior to the Screening Visit or has planned CRT during the study through the Follow-up Visit;
* Has clinically significant congenital heart disease, active myocarditis or constrictive pericarditis;
* Has current acute decompensated HF requiring additional treatment with diuretics, vasodilators and/or inotropic medications at the Screening Visit;
* Has clinically significant chronic renal insufficiency (i.e., estimated glomerular filtration rate \[eGFR\] \<30 mL/min/1.73 m2 calculated by the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] creatinine equation) at the Screening Visit.

Primary outcomes:
measure: Change from baseline to end of treatment (EOT) in left ventricular ejection fraction (LVEF) as assessed by two-dimensional echocardiography (2D-echo)
timeFrame: 12 Weeks
measure: Change from baseline to EOT in left ventricular end-systolic volume (LVESV) index as assessed by 2D-echo
timeFrame: 12 Weeks
measure: Change from baseline to EOT in left ventricular end-diastolic volume (LVEDV) index as assessed by 2D-echo
timeFrame: 12 Weeks
measure: Change from baseline to EOT in left atrial volume (LAV) as assessed by 2D-echo
timeFrame: 12 Weeks
measure: Change from baseline to EOT in N-terminal pro b-type natriuretic peptide (NT-pro-BNP) values
timeFrame: 12 Weeks
measure: Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) scores from baseline
timeFrame: 16 Weeks
measure: Number of subjects with treatment-emergent adverse events
timeFrame: Up to 16 Weeks
measure: Trough plasma concentrations of JTT-861
timeFrame: Weeks 4, 8 and 12
measure: Post-dose plasma concentrations of JTT-861
timeFrame: Weeks 2, 4 and 8
Secondary outcomes:
Other outcomes:
Locations:
city: Crystal River
country: United States
facility: Nature Coast Clinical Research
state: Florida
city: Hialeah
country: United States
facility: Indago Research & Health Center, Inc.
state: Florida
city: Miami Lakes
country: United States
facility: Pharma Medical Innovation, Inc.
state: Florida
city: Park Ridge
country: United States
facility: Affinity Health
state: Illinois
city: Hammond
country: United States
facility: ASHA Clinical Research-Munster, LLC
state: Indiana
city: West Monroe
country: United States
facility: Monroe Research, LLC
state: Louisiana
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Rosedale
country: United States
facility: Laurelton Heart Specialist P.C.
state: New York
city: Greensboro
country: United States
facility: Medication Management, LLC
state: North Carolina
city: Camp Hill
country: United States
facility: Capital Area Research, LLC
state: Pennsylvania
city: Rock Hill
country: United States
facility: Onsite Clinical Solutions, LLC
state: South Carolina
city: Beaumont
country: United States
facility: NextStage Clinical Research-Beaumont- (01)
state: Texas
city: Cypress
country: United States
facility: Cypress Heart and Vascular Center
state: Texas
city: Port Arthur
country: United States
facility: NextStage Clinical Research-Port Arthur-(02)
state: Texas
city: Sherman
country: United States
facility: Sherman Clinical Research
state: Texas
city: Waco
country: United States
facility: Waco Cardiology Associates - NextStage Clinical Research
state: Texas
city: Burgas
country: Bulgaria
facility: Ambulatory for Specialized Outpatient Medical Care in Cardiology Individual Practice- Dr. Elena Dotcheva EOOD
city: Pleven
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Georgi Stranski, EAD
city: Pleven
country: Bulgaria
facility: Multiprofile Hospital For Active Treatment Heart and Brain EAD
city: Sofia
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD
city: Sofia
country: Bulgaria
facility: Diagnostic Consultative Center Convex EOOD
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment. Sv Anna - Sofia AD
city: Brno
country: Czech Republic
facility: Centrum pro zdraví, s.r.o.
city: Brno
country: Czech Republic
facility: Vojenská nemocnice Brno
city: Brno
country: Czech Republic
facility: Fakultní nemocnice Brno
city: Náchod
country: Czech Republic
facility: Edumed s.r.o.
city: Ostrava-Poruba
country: Czech Republic
facility: Fakultní nemocnice Ostrava
city: Katowice
country: Poland
facility: Kardio Brynów Sp. z o.o.
city: Piotrków Trybunalski
country: Poland
facility: Trialmed CRS Piotrków Trybunalski
city: Sopot
country: Poland
facility: NZOZ "Pro Cordis" Sopockie Centrum Badań Kardiologicznych Paweł Miękus
city: Wrocław
country: Poland
facility: 4 Wojskowy Szpital Kliniczny z Polikliniką Samodzielny Publiczny Zakład Opieki Zdrowotnej we Wrocławiu
city: Brasov
country: Romania
facility: Thera Card S.R.L
city: Brasov
country: Romania
facility: Spitalul Clinic Judetean De Urgenta Brasov
city: București
country: Romania
facility: Spitalul Clinic De Urgență Sf. Pantelimon București
city: București
country: Romania
facility: Spitalul Universitar de Urgență București
city: Buzău
country: Romania
facility: Mat Cord Biomedica SRL
city: Cluj-Napoca
country: Romania
facility: Angiocare S.R.L.
city: Craiova
country: Romania
facility: Cardio Med SRL
city: Craiova
country: Romania
facility: Spitalul Clinic Județean de Urgență Craiova
city: Târgu Mureș
country: Romania
facility: Cardio Med SRL
city: Târgu Mureș
country: Romania
facility: CMI Dr. Podoleanu Cristian
city: A Coruña
country: Spain
facility: Hospital Clínico Universitario de Santiago
city: Barcelona
country: Spain
facility: Hospital del Mar - Parc de Salut Mar
city: Ferrol
country: Spain
facility: Area Sanitaria De Ferrol - Hospital Arquitecto Marcide
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro - Majadahonda
city: Murcia
country: Spain
facility: Hospital Clínico Universitario Virgen de la Arrixaca
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitari i Politècnic La Fe
Study officials:
References: