ELAM-PH2-HFPEF — design and population

§2Design and population

§2.1Design and allocation

Design class

Randomised, double-blind, placebo-controlled, parallel-group

Masking

Double-blind (participant, investigator and sponsor)

Arms

5

Allocation

Randomised across dose arms and a common comparator

Endpoint adjudication

Not applicable to the primary endpoint of this design

Data monitoring

As specified in the protocol

§2.2Arms

Table 2. Randomised arms. Illustrative: arm-level allocations are reconstructed by the Institute from the design class and the randomised total where the published report does not state them.

§2.3Population

Indication. Heart failure with preserved ejection fraction and obesity

Symptomatic heart failure with a left ventricular ejection fraction of 50 % or above, occurring with obesity as a dominant phenotypic driver.

Geographic footprint. Taiwan · New Zealand · Mexico · China.

§2.4Eligibility as the Institute reads it

• Included. Symptomatic heart failure with a left ventricular ejection fraction of 50 % or above, occurring with obesity as a dominant phenotypic driver.
• Excluded. Participants for whom the intervention is contraindicated, including not established — no marketing authorisation. Exclusion criteria narrow the population to which the estimate applies and are the principal source of indirectness where a trial estimate is applied to ordinary practice.