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Efficacy and Safety With Early Treatment of Finerenone in Hospitalized Patients With Heart Failure

Status: Recruiting
Location: See all (21) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

FACILITATE-HF is a multicenter, randomized, double-blind, placebo-controlled trial designed to determine whether initiation of finerenone during the early phase of hospitalization has beneficial effects in patients with AHF who have left ventricular ejection fraction 40% or more.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients ≥18 years of age, male or female\<br\>

• Current hospitalization with AHF requiring intravenous loop diuretics or vasodilators during the index admission\<br\>

• Patients have to have at least one of new or worsening symptoms due to HF and one of new or worsening physical examination findings due to HF \<br\> (i) symptom\<br\> dyspnoea, decreased exercise tolerance, or fatigue\<br\> (ii) physical examination\<br\> peripheral edema, increasing abdominal distention or ascites, pulmonary rales/crackles/crepitations, increased jugular venous pressure and/or hepatojugular reflux, S3 gallop, clinically significant or rapid weight gain\<br\>

• Patients who are not hemodynamically unstable as defined by meeting the following criteria\<br\>

‣ Systolic blood pressure ≥100 mmHg and no symptoms of hypotension within 6 hours prior to randomization\<br\>

⁃ No increase in intravenous diuretic dose or intravenous vasodilators within 6 hours prior to randomization with worsening HF symptom\<br\>

⁃ Without cardiogenic shock, no use of inotropes or vasopressors, no use of mechanical circulatory support, not requiring intubation after admission, and not expected to require inotropes, vasopressors, mechanical circulatory support or intubation during the index hospitalization\<br\>

• NTproBNP ≥1500 pg/mL or BNP ≥375 pg/mL (For patients treated with ARNI in the previous 4 weeks prior to randomization, only NT-proBNP values should be used)\<br\>

• Most recent LVEF ≥40% within the past 1 year \<br\>

• Randomization within 24 hours after admission, and drug administration within 36 hours after admission \<br\>

• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol\<br\>

• Signed informed consent must be obtained prior to participation in the study\<br\>

Locations
Other Locations
Japan
Japanese Red Cross Fukuoka Hospital
NOT_YET_RECRUITING
Fukuoka
Chita Peninsula General Medical Center
RECRUITING
Handa
Iizuka Hospital
RECRUITING
Iizuka
Juntendo University Shizuoka Hospital
NOT_YET_RECRUITING
Izunokuni
Chutoen General Medical Center
RECRUITING
Kakegawa
Saitama Medical Center
NOT_YET_RECRUITING
Kawagoe
Gunma Prefectural Cardiovascular Center
NOT_YET_RECRUITING
Maebashi
Gunma University Hospital
RECRUITING
Maebashi
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
NOT_YET_RECRUITING
Nagoya
Nagoya University Hospital
RECRUITING
Nagoya
National Center for Geriatrics and Gerontology
NOT_YET_RECRUITING
Ōbu
Osaka General Medical Center
RECRUITING
Osaka
Kitasato University Hospital
NOT_YET_RECRUITING
Sagamihara
Kindai University Hospital
RECRUITING
Sakai
Hokkaido Cardiovascular Hospital
RECRUITING
Sapporo
National Cerebral and Cardiovascular Center
NOT_YET_RECRUITING
Suita
The University of Osaka Hospital
RECRUITING
Suita
NHO Takasaki General Medical Center
RECRUITING
Takasaki
Juntendo University Hospital
RECRUITING
Tokyo
Ehime University Hospital
RECRUITING
Tōon
Toyota Kosei Hospital
RECRUITING
Toyota
Contact Information
Primary
Yuya Matsue, MD
yuya8950@gmail.com
81-3-3813-3111
Time Frame
Start Date: 2026-02
Estimated Completion Date: 2028-09-30
Participants
Target number of participants: 550
Treatments
Experimental: Finerenone
Patients will be randomized 1:1 to either finerenone or placebo.
Placebo_comparator: Placebo
Placebo tablets matching finerenone are administered orally
Related Therapeutic Areas
Sponsors
Leads: Juntendo University

This content was sourced from clinicaltrials.gov