Phase
Condition
Congestive Heart Failure
Heart Failure
Chest Pain
Treatment
Placebo
1,3-butanediol
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
The study will enroll adult patients (≥18 years) admitted with AHF as the primary diagnosis, meeting all the following criteria:
Documented new or worsening symptoms due to heart failure with at least one of thefollowing: persistent dyspnea at rest or with minimal exertion, or fatigue.
Objective evidence of worsening heart failure, consisting of at least two physicalexamination findings consistent with fluid retention and/or end-organ hypoperfusionor one physical examination finding and at least one laboratory criterion: a) Physical examination findings considered to be due to heart failure, includingnew or worsened: i. Peripheral edema ii. Increasing abdominal distention or ascites (in the absence of primary hepatic disease) iii. Pulmonaryrales/crackles/crepitations iv. Increased jugular venous pressure and/orhepatojugular reflux v. S3 gallop vi. Clinically significant or rapid weight gainthought to be related to fluid retention b) Laboratory evidence of worsening HF, ifobtained within 24 hours of presentation, including: i. Increased B-type natriureticpeptide (BNP) / N-terminal pro-BNP (NT-proBNP) concentrations consistent withdecompensation of heart failure. In patients with chronically elevated natriureticpeptides, an increase of >30% above baseline should be noted. ii. Radiological evidence of pulmonary congestion iii. Echocardiographic criteriainclude: Dilated inferior vena cava with minimal collapse on inspiration; decreasedleft ventricular outflow tract (LVOT) minute stroke distance (velocity time integral [VTI]); septal or lateral E/e' >15 or >12, respectively; D-dominant pulmonaryvenous inflow pattern. iv. Invasive diagnostic evidence with right heart catheterization showing apulmonary capillary wedge pressure ≥18 mmHg, central venous pressure ≥12 mmHg, or acardiac index <2.2 L/min/m2
Treatment with at least 40 mg of intravenous furosemide or its equivalent and/orintravenous vasoactive drugs and/or inotropic drugs.
An LVEF of ≤35% is required, measured during the present hospitalization.
Participants must present with elevated levels of natriuretic peptides, specificallyNT-proBNP ≥600 pg/mL or BNP ≥150 pg/mL. For those in atrial fibrillation at the timeof inclusion, NT-proBNP levels must be ≥900 pg/mL or BNP ≥225 pg/mL.
The enrollment window extends to the first five days of the hospital stay.
Exclusion
Exclusion Criteria:
Current hospitalization for AHF triggered by significant arrhythmia (atrialfibrillation/flutter with sustained ventricular response >110 beats per minute,clinically significant bradycardia, or sustained ventricular tachycardia)
Cardiogenic shock in INTERMACS level 1 or 2 (i.e. unstable hemodynamics despiteinotropic/vasopressor therapy)
Likelihood or current use of mechanical circulatory support
Recent cardiac surgery within 3 days
Ongoing severe infection or sepsis, severe anemia, acute exacerbation of chronicobstructive pulmonary disease, pulmonary embolism, or cerebrovascular accident
Significant primary valvular disease (hemodynamically severe uncorrected primarycardiac valvular disease)
Planned implantation of a cardiac resynchronization therapy device
eGFR <15 mL/min/1.73 m2 during current hospitalization (unless ongoing continuousrenal replacement therapy) or recurring dialysis
Known obstructive hypertrophic cardiomyopathy, congenital heart disease, acutemechanical cause of acute heart failure (e.g., papillary muscular rupture), acutemyocarditis, or constrictive pericarditis according to the treating physician
Type 1 diabetes
Advanced liver disease (Child-Pugh class C)
Dementia or other cognitive disorder making the patient unable to give informedconsent
Pregnancy or breastfeeding
Inability to intake oral substances or severe dysphagia
Significant gastrointestinal disease (i.e. severe inflammatory bowel disease orgastric ulcer)
Adherent to a ketogenic diet within 30 days of enrollment
Awaiting cardiac transplantation
Very severe lung disease and/or treatment with continuous home oxygen therapy
Major comorbidity, medical condition, or health issue that, according to theinvestigator's judgment, would hinder the participant's capacity to engage in orsuccessfully finish the study
Study Design
Study Description
Connect with a study center
Department of Cardiology, Aalborg University Hospital
Aalborg,
DenmarkSite Not Available
Department of Cardiology, Aarhus University Hospital
Aarhus N, 8200
DenmarkActive - Recruiting
Department of Cardiology, Herlev-Gentofte Hospital
Copenhagen,
DenmarkSite Not Available
Department of Cardiology, Rigshospitalet
Copenhagen,
DenmarkSite Not Available
Department of Cardiology, Gødstrup Hospital, Herning, Denmark
Herning, 7400
DenmarkSite Not Available
Department of Cardiology, Copenhagen University Hospital - Amager and Hvidovre Hospital
Hvidovre,
DenmarkActive - Recruiting
Department of Cardiology, Odense University Hospital
Odense, 5000
DenmarkSite Not Available
Department of Cardiology, Viborg Hospital
Viborg, 8800
DenmarkActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.