Tokyo, Jan. 12 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060251) titled 'A Network Meta-analysis of Angiotensin Receptor-Neprilysin Inhibitors and Cancer Risk Based on Parallel-Group Individual Randomized Controlled Trials' on Jan. 12.

Study Type: Others,meta-analysis etc

Primary Sponsor: Institute - Yokohama City University Graduate School of Medicine

Condition: Condition - Hypertension, Coronary artery disease, Heart failure, Chronic kidney disease, Atrial fibrillation, High risk vascular disease, Cerebrovascular accident, Diabetes mellitus, High normal blood pressure, Pre-hypertension Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The risk of cancer from Renin-angiotensin-system (RAS)-acting agents has been much debated. However, few randomized clinical trials (RCTs) have directly compared RAS-acting agents. Furthermore, the true cancer risk of angiotensin receptor-neprilysin inhibitor (ARNI) is unknown. A network meta-analysis is the best analytical technique to enable indirect comparison among these agents. Therefore, we will conduct systematic review and network meta-analysis to assess the association between ARNI and cancer risk in a comprehensive analysis of data from RCTs. Basic objectives2 - Safety

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - We will include only English full-articles. The other article including non-English article, short article, and conference abstract will be excluded. We will include parallel-group individual RCTs but not cluster RCTs, or cross-over RCTs. A trial with three or more arms will be accepted. Along with superiority trials, non-inferiority trials will be allowed. Any phase RCT may be included. Trials not reporting data about safety outcomes will be excluded.

Key inclusion criteria are as follows. (1) RCTs including RAS-acting agents and control treatment in adult patients. Controls will be classified as placebo or non-placebo. Non-placebo drugs will be defined as any RAS-acting agents. (2) The study with multiple arms where RAS-acting agent is included at least one arm. (3) The study illustrates the safety outcome of cancer. Key exclusion criteria - (1) Systematic review or meta-analysis articles. (2) Retrospective analysis. (3) Single prospective cohort study without a control group. (4) Non-RCT. (5) The republished research literature is excluded unless the research includes new findings related to cancers listed in inclusion criteria. (6) Studies with no or insufficient safety outcomes at the time of the literature search. Two investigators independently will screen all titles, abstracts, and full texts for eligibility. Final inclusion will be decided after resolving discrepancies between the two investigators.

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 07 Month 12 Day Anticipated trial start date - 2026 Year 01 Month 12 Day Last follow-up date - 2027 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068916

Disclaimer: Curated by HT Syndication.