Evaluating Clinical Trial Experiences of Individuals With Congestive Heart Failure

NCT05516290 | Not Yet Recruiting

• 1 other identifier: 85707278
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Congestive Heart Failure

Keywords

congestive heart failure; heart failure

Outcome Measures

Primary Outcomes (2)

• Number of patient decides to enroll in a congestive heart failure clinical trial

  3 months

• Rate of patients who remain in a congestive heart failure clinical trial to trial completion

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Congestive Heart Failure patients who are actively considering enrolling in an interventional clinical trial, but have not yet completed enrollment and registration.

You may qualify if:

• 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)

You may not qualify if:

• Inability to perform regular electronic reporting
• Patient does not understand, sign, and return consent form
• No diagnosis of congestive heart failure confirmed

Sponsors & Collaborators

• Power Life Sciences Inc.: lead

Related Publications (3)

• 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 BACKGROUND

• White M, Rouleau JL. Overview of clinical trials in congestive heart failure. Can J Cardiol. 1993 Sep;9(7):629-34.

  PMID: 8221362 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Michael B Gill

  Power Life Sciences Inc.

  STUDY DIRECTOR

Central Study Contacts

Michael B Gill

CONTACT

415-900-4227; bask@withpower.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: August 25, 2022
• Study Start: September 1, 2024
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 2, 2024

Record last verified: 2023-12