A Study to Adapt a Measure of Heart Failure to an Adolescent Population

Overview

About this study

The purpose of this study is to understand the experience of heart failure symptoms on the adolescent patient population, including the impact of symptoms on quality of life and wellbeing.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Patient Inclusion Criteria:

  • Adolescents and young adults age 12 to 21 years at time of consent who have had NYHA Class II or higher heart failure in the preceding two years.
  • Actively being followed by a pediatric heart failure specialist with at least one visit in the past year, or actively being followed by a pediatric cardiologist with Heart Failure as an active diagnosis and history of consultation with a pediatric heart failure specialist.
  • English speaking.
  • Inpatient or outpatient.
  • Any etiology of heart failure including but not limited to cardiomyopathy, myocarditis, and congenital heart disease, unless mentioned in Exclusion Criteria.
  • May have systolic or diastolic heart failure, or Fontan/single ventricle heart failure.
  • May have had advanced cardiac therapies including pacemakers, ICDs, ventricular assist devices, or cardiac transplant as long as other Inclusion Criteria are met.

Caregiver Inclusion Criteria:

  • Parent(s)/guardian(s)/caregiver(s) of participating adolescent/young adult subjects with heart failure.
  • Age 18 or older.
  • English speaking.
  • Significant co-morbidities that may greatly impact their ability to distinguish symptoms of heart failure, such as: muscular dystrophy, active malignancy, or primary non-cardiac organ failure (e.g., renal failure with uremic cardiomyopathy).
  • Clinical condition that would interfere with their ability to participate in a focus group or interview (e.g., severe developmental delay or other cognitive impairment).

Patient Exclusion Criteria: 

  • Significant co-morbidities that may greatly impact their ability to distinguish symptoms of heart failure, such as: muscular dystrophy, active malignancy, or primary non-cardiac organ failure (e.g., renal failure with uremic cardiomyopathy).
  • Clinical condition that would interfere with their ability to participate in a focus group or interview (e.g., severe developmental delay or other cognitive impairment).

Caregiver Exclusion Criteria:

  • Clinical condition that would interfere with their ability to participate in a focus group or interview (e.g., severe developmental delay or other cognitive impairment).

     

 

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Jonathan Johnson, M.D.

Open for enrollment

Contact information:

Emma Behnken

(507)293-0177

Behnken.Emma@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20458243

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