Evaluating Clinical Trial Experiences of Individuals With Congestive Heart Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Congestive Heart Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An In Depth Study Investigating Patterns of Patients In Congestive Heart Failure Clinical Trials
Overview
Clinical trial participation has always been substantially skewed toward certain demographic groups. However, there has been little study on whether trial qualities impact participation in either a positive or negative way. The goal of this research is to identify the characteristics that consistently restrict patients' ability to participate in or complete a trial in which they were initially interested. This data will be evaluated via a number of demographic lenses in order to find trends that could benefit future Congestive Heart Failure sufferers.
Primary outcome measures
- Number of patient decides to enroll in a congestive heart failure clinical trial [Time frame: 3 months]
- Rate of patients who remain in a congestive heart failure clinical trial to trial completion [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- Lives in the United States
- Is 18+ years old
- Participant has a diagnosis of congestive heart failure
- Participant has enrolled in an interventional clinical for congestive heart failure (self-reported)
Exclusion criteria
- Inability to perform regular electronic reporting
- Patient does not understand, sign, and return consent form
- No diagnosis of congestive heart failure confirmed
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-crossover
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Betkowski AS, Hauptman PJ. Update on recent clinical trials in congestive heart failure. Curr Opin Cardiol. 2000 Jul;15(4):293-303. doi: 10.1097/00001573-200007000-00015. PMID 11139094
- White M, Rouleau JL. Overview of clinical trials in congestive heart failure. Can J Cardiol. 1993 Sep;9(7):629-34. PMID 8221362
- Samman Tahhan A, Vaduganathan M, Kelkar A, Georgiopoulou VV, Kalogeropoulos AP, Greene SJ, Fonarow GC, Gheorghiade M, Butler J. Trends in Heart Failure Clinical Trials From 2001-2012. J Card Fail. 2016 Mar;22(3):171-9. doi: 10.1016/j.cardfail.2015.06.014. Epub 2015 Jun 21. PMID 26106806
Identifiers
NCT: NCT05516290 · 85707278