A study to learn how safe starting vericiguat at a dose of 5 milligrams is in participants with chronic heart failure with reduced ejection fractio
- Conditions
- Chronic heart failure with reduced ejection fractionMedDRA version: 26.1Level: LLTClassification code: 10078289Term: Heart failure with reduced ejection fraction Class: 10007541MedDRA version: 20.0Level: LLTClassification code: 10008908Term: Chronic heart failure Class: 10007541Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- CTIS2023-507682-25-00
- Lead Sponsor
- Bayer AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 138
LVEF of <45% assessed within 12 months before Visit 1 by local any imaging method, and no subsequent LVEF measurement > 45%. The most recent measurement must be used to determine eligibility., SBP = 100 mmHg at screening and Visit 1 (pre-treatment), No changes in GDMT dosing (including beta blockers, ACEI/ARBs, ARNI, MRAs, hydralazine-nitrate combinations, SGLT2 inhibitors, ivabradine, or oral diuretics) •Within 4 weeks of screening for participants without a HF event =6 months prior to screening •within 2 weeks of screening for participants with a HF event =6 months prior to screening •planned during study participation, No expected medical procedures to occur 2 weeks before screening or during study participation., Participants with ( group 1) OR without (group 2) recent worsening HF event: Group 1: History of chronic HF (NYHA class II symptomatic-IV) on GDMT with recent HFevent within 6 months of screening or outpatient IV / SC diuretic use within 3 months before screening. OR Group 2: History of chronic HF (NYHA class II symptomatic-IV) on GDMT without recent HF event within 6 months of screening or outpatient IV / SC diuretic use within 3 months before screening.
History of symptomatic hypotension 4 weeks before screening., Active endocarditis or constrictive pericarditis., Hemodynamic instability of hypovolemia within 4 weeks of screening and during screening period., Currently hospitalized., eGFR based on the CKD-EPI Creatinine Equation of <15mL/min/1.73 m2 within 30 days before Visit 1 or on chronic dialysis. For participants with multiple eGFR results during screening, the most recent value will be used to determine eligibility, Severe hepatic insufficiency defined as ALBI Grade 3 or hepatic encephalopathy, or has hepatic laboratory abnormalities (ALT or AST =3 × ULN or total bilirubin =2 × ULN). Exceptions for Gilbert’s syndrome will be considered. Albumin, ALT, AST, and total bilirubin results within 30 days before Visit 1 may be used for assessment of laboratory abnormalities or the calculation of the ALBI score. For participants with multiple albumin and/or total bilirubin results during screening, the most recent value for each test will be used to calculate ALBI score., Malignancy or other noncardiac condition limiting life expectancy to <3years., Requires continuous home oxygen for severe pulmonary disease., Interstitial lung disease., Known allergy or hypersensitivity to vericiguat, any of its constituents, or any other sGC stimulator., Amyloidosis or sarcoidosis., Primary valvular heart disease requiring surgical procedure or intervention or has undergone a vascular surgical procedure or intervention within 3months before Visit 1, Concurrent or anticipated concomitant use of PDE5 inhibitors such as vardenafil, tadalafil, and sildenafil during the study., Concurrent use of an sGC stimulator such as riociguat or vericiguat., Prior (within 2 weeks prior to screening) or anticipated concomitant administration of IV / SC diuretics or inotropes., Hypertrophic cardiomyopathy, Acute myocarditis or Takotsubo cardiomyopathy, Awaiting heart transplantation (United Network for Organ Sharing Class 1A /1B or equivalent) or has or anticipates receiving an implanted ventricular assist device, or has received a heart transplant., Tachycardia-induced cardiomyopathy and/or uncontrolled tachyarrhythmia., Acute coronary syndrome (unstable angina, NSTEMI, or STEMI), undergone CABG or PCI within 3months before Visit 1, or indication for coronary revascularization at the time of treatment assignment., Symptomatic carotid stenosis, TIA, or stroke within 3months before Visit 1., History of repaired or unrepaired simple congenital heart disease (e.g., atrial or ventricular septal defects, or patent ductus arteriosus) with ongoing hemodynamically significant residual lesions, or any history of complex congenital heart disease (e.g. tetralogy of Fallot, transposition of the great arteries, single ventricle disease) regardless of repair status.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the tolerability of 5 mg as a starting dose of vericiguat;Secondary Objective: To describe safety events of initiation of 5 mg dose, To further evaluate the tolerability of 5 mg as a starting dose of vericiguat;Primary end point(s): Treatment tolerability, defined as the completion of the two-week 5 mg dose without discontinuation of study intervention, Treatment tolerability, defined as the completion of the two-week 5 mg dose without moderate to severe symptomatic hypotension between Visit 1 and Visit 2
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Any AE reported between Visit 1 and 2;Secondary end point(s):Absence of AE related to study intervention between Visit 1 and Visit 2.;Secondary end point(s):Continuous intake of study intervention between Visit 1 and Visit 2 or restart of study intervention after any temporary interruption.