Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07428135
Eligibility Criteria:
Inclusion Criteria (HEART Platform)
* Participants are eligible for inclusion if they meet all of the following:
* Age ≥18 years (or legal age of majority in participant's country of residence).
* Diagnosis of heart failure, and eligible to be classified into one of the HEART platform states at the time of randomization:
* State 1: Worsening Heart Failure (WHF): currently hospitalized for acute decompensated heart failure or emergency department patients requiring intravenous therapy for heart failure; OR
* State 2: Ambulatory Heart Failure: stable outpatients with established heart failure diagnosis, receiving ongoing HF management and without HF hospitalization within the prior 30 days.
* Able and willing to provide written informed consent (or consent via a legally authorized representative, where applicable).
* Meets all applicable domain-specific eligibility criteria for at least one active HEART Platform domain at the time of screening/randomization.
Exclusion Criteria (HEART Platform)
* Participants will be excluded if any of the following apply:
* Inability to provide informed consent (and no legally authorized representative available when applicable).
* Not eligible for assignment to either HEART platform state (State 1 or State 2).
* Presence of conditions or circumstances that, in the investigator's opinion, would make study participation unsafe or not feasible (e.g., inability to comply with study procedures or follow-up).
* Does not meet the eligibility requirements for any active HEART Platform domain.
* Any domain-specific exclusion criteria applicable to the intervention/domain(s) for which the participant would otherwise be eligible.
* Additional inclusion and exclusion criteria apply for each individual HEART Platform domain and will be specified in the relevant domain protocol(s).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07428135
Study Brief:
Protocol Section:
NCT07428135