Trial Condition(s):
A study to learn how safe starting vericiguat at a dose of 5 milligrams is in participants with chronic heart failure with reduced ejection fraction
21683
Not Available
2023-507682-25-00
Researchers are looking for a better way to treat people who have chronic heart failure with reduced ejection fraction. Chronic heart failure with reduced ejection fraction (HFrEF) is a long-term condition that occurs when the heart is too weak to pump enough blood to the rest of the body. This results in a reduced supply of the oxygen that the body requires to function properly. The common symptoms of HFrEF include breathlessness, weakness, fatigue, and swelling in the ankles and legs. If left untreated, heart failure can lead to other serious health problems, including damage to other organs, which may result in hospital stays or even death.
Vericiguat is an approved drug for use in people with chronic HFrEF. It works by activating a protein called soluble guanylate cyclase, which helps dilating the blood vessels and in turn improves heart function.
Currently, treatment with vericiguat starts at a daily dose of 2.5 milligrams (mg), which increases to 5 mg after 2 weeks. The dose is then increased to the target dose of 10 mg after another 2 weeks.
In this study, researchers are trying to learn how well participants can tolerate and how safe it is to start vericiguat at a dose of 5 mg. Starting directly at the 5 mg dose is expected to help reach the target dose of 10 mg faster. Participants will take vericiguat 5 mg as a tablet by mouth once daily along with their regular heart medications.
At the start of the study, study doctors will check participants’ medical history and perform full health check-ups to confirm if they can take part in the study. Throughout the study, study doctors will monitor participants’ previous and current medications, their heart health, and their overall well-being. This will help researchers assess how safe the study drug is and if they experience adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective of whether they think they are related to the study treatment.
Access to study treatment after the end of this study is not planned.
Everyone, including study doctors and participants, will know what drug the participants receive during the study. Participants may be in the study for about 4 weeks.
Participants may not benefit from the treatment as the study is designed to assess safety and tolerability: the duration of the study is very short and participants will be taking a low dose of vericiguat without moving to the target dose of 10 mg during the study. However, the findings of this study may enable people with chronic HFrEF to safely skip one initial dosing step and reach the target dose of vericiguat faster.
Participants may experience medical problems such as low blood pressure, upset stomach, nausea, dizziness, and headache. Researchers will monitor and manage all these, and other, medical problems participants may have during the study.
- Has an Left ventricle ejection fraction (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. - systolic blood pressure (SBP) ≥ 100 mmHg at screening and Visit 1 (pre-treatment). - No changes in guideline-directed medical therapy for heart failure (GDMT) dosing (including beta blockers, angiotensin-converting enzyme inhibitor/ angiotensin II receptor blocker (ACEI/ARBs), angiotensin receptor-neprilysin inhibitor (ARNI), mineralocorticoid receptor antagonist (MRAs), hydralazine-nitrate combinations, sodium-glucose cotransporter 2 i(SGLT2) inhibitors, ivabradine, or oral diuretics): • Within 4 weeks of screening for participants without a heart failure (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 intravenous/ subcutaneous (IV / SC) diuretic use within 3 months before screening.
- History of symptomatic hypotension 4 weeks before screening - Primary valvular heart disease requiring surgical procedure or intervention or has undergone a vascular surgical procedure or intervention within 3months before visit 1 - 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, non-ST elevation myocardial infarction (NSTEMI), or ST elevation myocardial infarction (STEMI), undergone coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within 3months before Visit 1, or indication for coronary revascularization at the time of treatment assignment. - Symptomatic carotid stenosis, transient ischemic attack (TIA), or stroke within 3 months 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. - Active endocarditis or constrictive pericarditis. - Hemodynamic instability or hypovolemia within 4 weeks of screening and during the screening period. - Currently hospitalized. - estimated glomerular filtration rate (eGFR) based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine Equation of <15 mL/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 albumin to bilirubin ratio (ALBI) Grade 3 or hepatic encephalopathy, or has hepatic laboratory abnormalities (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3 ×upper limit of normal (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 soluble guanylate cyclase (sGC) stimulator. - Amyloidosis or sarcoidosis. - Concurrent or anticipated concomitant use of phosphodiesterase type 5 (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.
Locations | Status | |
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Locations ASST Papa Giovanni XXIII Bergamo, Italy, 24127 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ASST Spedali Civili di Brescia Brescia, Italy, 25123 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fondazione IRCCS Policlinico San Matteo Pavia, Italy, 27100 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Molinette Hospital University of Torino Torino, Italy, 10126 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations IRCCS Centro Cardiologico Monzino S.p.A Milano, Italy, 20138 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universita degli Studi di Roma "La Sapienza" - Umberto I Policlinico di Roma Rome, Italy, 00161 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CLINICAL BEST SOLUTIONS SP. Z O.O. SP.K. Warszawa, Poland, 02-793 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations NZOZ "Twoja Przychodnia" Sp. z o.o. Lublin, Poland, 20-857 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centrum Medyczne Zdrowa Krakow, Poland, 31-216 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Vita Longa Sp. z o.o. Katowice, Poland, 40-748 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Malopolskie Centrum Sercowo-Naczyniowe PAKS Chrzanow, Poland, 32-500 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations IRMED Osrodek Badan Klinicznych Piotrkow Trybunalski, Poland, 97-300 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ascension Saint Agnes Heart Care Baltimore, United States, 21229 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Clinico Universitario de Santiago de Compostela | Cardiology Department Santiago de Compostela, Spain, 15706 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital la Paz Madrid, Spain, 28046 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Clínico Universitario de Valencia Valencia, Spain, 46010 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital del Mar | Cardiology Department Barcelona, Spain, 08003 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitari de Bellvitge | Bellvitge Biomedical Research Institute - Cardiology Department Barcelona, Spain, 08907 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Ramon y Cajal | Cardiology - Research Unit Madrid, Spain, 28034 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Capio Citykliniken - Hjartmottagning Lund, Sweden, 222 21 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Karolinska Universitetssjukhuset Stockholm, Sweden, S-171 76 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Danderyds sjukhus Stockholm, Sweden, 182 88 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Eszak-Pesti Centrumkorhaz-Honvedkorhaz Budapest, Hungary | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Semmelweis Egyetem Belgyógyaszati és Haematológiai Klinika, Kardiológia Budapest, Hungary, 1088 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Somogy Varmegyei Kaposi Mor Oktato Korhaz Kaposvar, Hungary, 7400 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tolna Varmegyei Balassa Janos Korhaz Szekszard, Hungary, 7100 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Complex Rendelo Med Zrt. Szekesfehervar, Hungary, 8000 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations COROMED SMO KFT Pecs, Hungary, 7623 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Chear Center LLC Bronx, United States, 10455 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations St. Louis Heart & Vascular, PC Saint Louis, United States, 63136 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro de Investigación y Prevención Cardiovascular Buenos Aires, Argentina, C1119ACN | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Advanced Cardiovascular, LLC - Alexander City Alexander City, United States, 35010 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Reid Physician Associates | Cardiology Department Connersville, United States, 47331 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro de Investigaciones Clínicas CABA, Argentina, C1018DES | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro de Investigaciones Clinicas del Litoral Santa Fe, Argentina, S3000FWO | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Instituto Médico de la Fundación Estudios Clinicos Rosario, Argentina, S2000DEJ | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Inst. de Cardiología de Corrientes Juana Francisca Cabral Corrientes, Argentina, 3400 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
A Phase 2b open-label clinical study to evaluate the tolerability and safety of an initiation dose of 5 mg of Vericiguat in participants with chronic heart failure with reduced ejection fraction
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
N/A
Blinding:
N/A
Assignment:
Single Group Assignment
Trial Arms:
1