๐ฌIn plain words
What the trial is, and whether it could suit you
This observational feasibility study aims to assess (i) how practical and acceptable repeated KCCQ assessments are; (ii) the connection between changes over time in KCCQ scores and signs of congestion; and (iii) clinical outcomes, including worsening heart failure events or cardiovascular death (CVD), and the time between 5- and 10-point KCCQ changes and clinical events.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* Established diagnosis of chronic HF with reduced, mildly reduced, or preserved ejection fraction, NYHA II-III
* History of heart failure (HF) hospitalization within the last 6 months before enrollment, defined as the presence of dyspnea, elevated NT-proBNP โฅ300 pg/mL (sinus rhythm) or โฅ600 pg/mL (if AF), and 2 of the following: i. Rales on chest auscultation or signs of congestion on X-ray/CT scan; ii. Peripheral Oedema; iii. Loop diuretics IV at admission
* Free of signs and symptoms of congestion, defined as JVP of \<8 cm, with no orthopnea, pulmonary rales, and with trace peripheral edema or no edema.
* Stable doses of oral loop diuretics, if prescribed
* Ability to provide informed consent
Exclusion Criteria:
* Acute coronary syndrome, cardiac surgery, pulmonary embolism, cerebrovascular accident, ablation of atrial flutter/fibrillation, valve repair/replacement, implanted cardioverter defibrillator or urgent PCI within the last 3 months
* Planned interventions, including major cardiac surgery (coronary artery bypass grafting, valve repair/replacement, ventricular assist device, cardiac transplantation), coronary revascularization, implantation of a cardiac device or ablation of atrial flutter/fibrillation during the study
* Previous cardiac transplantation and candidates for heart transplantation
* Complex congenital heart disease
* Heart failure due to active myocarditis, pericardial constriction, known hypertrophic cardiomyopathy or cardiac amyloidosis, or uncorrected severe valvular heart disease
* Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease
* Cirrhosis, chronic active hepatitis, or other severe hepatic disease
* Significant drug or alcohol abuse during the last year
* Hemodialysis
* Infective endocarditis
* Any active cancer