Evaluation of Colchicine Efficacy in Reducing NT-proBNP Levels in Patients with Acute Decompensated Heart Failure: A Randomized, Double-Blind, Placebo-Controlled Trial

The primary objective of this randomized double-blind trial is to evaluate whether the administration of **colchicine** at a dose of 0.5 mg, compared to placebo, in patients with acute decompensated heart failure is associated with a reduction in NT-proBNP concentrations at 8 weeks post-hospital discharge. NT-proBNP is a biomarker indicative of clinical stability and risk in heart failure patients. The clinical relevance of this study lies in its potential to establish colchicine as a therapeutic option to improve outcomes in this patient population by stabilizing heart failure symptoms and reducing associated risks.

The clinical trial focuses on patients diagnosed with **acute decompensated heart failure**. The study population includes both male and female participants, aged 18 years and older, who have experienced an unscheduled visit due to symptoms or congestive signs of heart failure requiring treatment with intravenous diuretics. Participants must have a NT-proBNP concentration greater than 900 pg/ml at the screening visit. The trial does not involve a vulnerable population. The sponsor has not provided information regarding the total number of participants. Participants were selected based on specific clinical criteria, including the requirement for intravenous diuretics and clinical evidence of congestion. All participants have provided informed consent in writing. Lifestyle factors such as diet, physical activity, or habits are not specified in the available data.

The clinical trial is designed as a **randomized**, **double-blind**, controlled study to evaluate the efficacy of **colchicine** in patients with **acute decompensated heart failure**. The primary objective is to determine if the administration of colchicine 0.5 mg compared to placebo results in a decrease in NT-proBNP concentrations, a biomarker of clinical stability and risk, at eight weeks post-hospital discharge. The trial is expected to span approximately 56 days, with the estimated recruitment start date being February 8, 2021, and the anticipated end date on December 15, 2023.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to confirm eligibility based on criteria such as unscheduled visits for heart failure symptoms requiring intravenous diuretics, clinical evidence of congestion, NT-proBNP concentration greater than 900 pg/ml, age over 18 years, and provision of informed consent. Follow-up visits will be scheduled to monitor the primary endpoint of decreased NT-proBNP levels and secondary endpoints, including improvement in clinical stability, reduction in mortality rate, and total days of hospitalization. The end-of-study visit will conclude the participant's involvement, assessing the overall outcomes and any adverse events.

Participant involvement is expected to last for the duration of the trial, approximately eight weeks. Conditions that may lead to early termination from the study include withdrawal of consent, significant protocol deviations, or adverse events that compromise participant safety. The trial is conducted under strict adherence to ethical guidelines and regulatory requirements to ensure the integrity and reliability of the data collected.

The clinical trial involves the administration of **Colchicine**, marketed under the name **COLCHICINA SEID 0.5 mg comprimidos**. This experimental medication is presented in the form of a **tablet** and is intended for **oral use**. Each tablet contains 0.5 mg of the active substance **colchicine**, which is of chemical origin. The maximum daily dose is set at 2 mg, with a total treatment period not exceeding 56 days. The administration schedule involves taking the medication twice daily, ensuring that the total daily dose does not surpass the specified limit. Compliance with the dosing regimen will be monitored throughout the study to ensure adherence to the protocol.

In addition to the experimental treatment, a **placebo** will be used as a comparator in this double-blind trial. The placebo will be identical in appearance to the colchicine tablets but will not contain any active pharmaceutical ingredients. The placebo will be administered following the same dosing schedule as the experimental medication, ensuring that neither the participants nor the investigators are aware of the treatment allocation. This approach is designed to objectively assess the efficacy of colchicine in reducing NT-proBNP concentrations in patients with acutely decompensated heart failure.

Efficacy in this clinical trial will be assessed by evaluating the primary endpoint of decreased NT-proBNP levels, a biomarker indicative of clinical stability and risk in patients with acutely decompensated heart failure. The trial aims to determine if the administration of colchicine 0.5 mg compared to placebo results in a reduction of NT-proBNP concentrations at 8 weeks post-hospital discharge. Secondary endpoints include improvement of clinical stability, reduction in mortality rates, and total days of hospitalization. These parameters will be measured and collected at specified timepoints, with NT-proBNP levels serving as a key indicator of treatment efficacy. The trial is designed as a randomized double-blind study to ensure objective assessment of the outcomes.