ENROLLING_BY_INVITATION

A Preliminary Study for INFORMED

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Investigators will determine whether N-of-1 trials, as a pragmatic, participant-centered approach to medication optimization that can overcome key barriers of deprescribing, can lead to increased participant confidence regarding their preference to continue or discontinue beta-blockers in older adults with Heart Failure with Preserved Ejection Fraction (HFpEF).

Official Title

A Preliminary Study for the Intervention of an N-of-1 Protocol For Medication Optimization

Quick Facts

Study Start:2024-02-07

Study Completion:2026-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ENROLLING_BY_INVITATION

Study ID

NCT05585125

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Ambulatory adults age ≥ 65 years with HFpEF, according to ACC/AHA guidelines (signs and symptoms of heart failure AND ejection fraction ≥ 50%) 2. Taking beta-blocker	1. Alternate cause(s) of HFpEF Syndrome: 1. Severe aortic stenosis 2. Moderate-severe mitral stenosis 3. Constrictive pericarditis 4. High output HF 5. Infiltrative cardiomyopathy 2. Other compelling indication(s) for beta-blocker 1. Prior EF \< 50% 2. Hypertrophic cardiomyopathy 3. Angina 4. Acute coronary syndrome, myocardial infarction, or coronary artery bypass surgery in prior 3 years 5. History of ventricular tachycardia/arrhythmia 6. Atrial arrhythmia with hospitalization for rapid ventricular response, prior 1 year 7. Heart rate \>100 bpm within the prior 3 months 8. Atrial arrhythmia with ventricular rate \>90 per minute in the prior 3 months 9. Systolic blood pressure readings \>160 mmHg within the prior 3 months, unless classified as white coat hypertension/effect (and home blood pressures below 140 mmHg) 10. Non-cardiac indications (e.g., migraine prevention, anxiety symptom management, hyperthyroidism, essential tumor reduction) 3. Clinical instability (N-of-1 trials are appropriate for stable conditions only) 1. Decompensated heart failure 2. Hospitalization in the past 30 days 3. Medication changes or procedures in the prior 14 days that could confound observations/data at PI discretion 4. Anticipated medication changes or procedures in subsequent 3 months that could confound observations/data at PI discretion 5. Clinical instability from other medical issues 4. Estimated life expectancy \< 6 months 5. Moderate-severe dementia or psychiatric disorder precluding informed consent 6. Language barrier that will preclude informed consent and ability to comprehend study procedures 7. Non-compliance or inability to complete study procedures 8. Enrollment in a clinical trial not approved for co-enrollment 9. Any condition that, in the Principal Investigator or treating physician's opinion, makes the patient unsuitable for study participation

Inclusion Criteria

Exclusion Criteria

1. Ambulatory adults age ≥ 65 years with HFpEF, according to ACC/AHA guidelines (signs and symptoms of heart failure AND ejection fraction ≥ 50%)
2. Taking beta-blocker

1. Alternate cause(s) of HFpEF Syndrome:
1. Severe aortic stenosis
2. Moderate-severe mitral stenosis
3. Constrictive pericarditis
4. High output HF
5. Infiltrative cardiomyopathy
2. Other compelling indication(s) for beta-blocker
1. Prior EF \< 50%
2. Hypertrophic cardiomyopathy
3. Angina
4. Acute coronary syndrome, myocardial infarction, or coronary artery bypass surgery in prior 3 years
5. History of ventricular tachycardia/arrhythmia
6. Atrial arrhythmia with hospitalization for rapid ventricular response, prior 1 year
7. Heart rate \>100 bpm within the prior 3 months
8. Atrial arrhythmia with ventricular rate \>90 per minute in the prior 3 months
9. Systolic blood pressure readings \>160 mmHg within the prior 3 months, unless classified as white coat hypertension/effect (and home blood pressures below 140 mmHg)
10. Non-cardiac indications (e.g., migraine prevention, anxiety symptom management, hyperthyroidism, essential tumor reduction)
3. Clinical instability (N-of-1 trials are appropriate for stable conditions only)
1. Decompensated heart failure
2. Hospitalization in the past 30 days
3. Medication changes or procedures in the prior 14 days that could confound observations/data at PI discretion
4. Anticipated medication changes or procedures in subsequent 3 months that could confound observations/data at PI discretion
5. Clinical instability from other medical issues
4. Estimated life expectancy \< 6 months
5. Moderate-severe dementia or psychiatric disorder precluding informed consent
6. Language barrier that will preclude informed consent and ability to comprehend study procedures
7. Non-compliance or inability to complete study procedures
8. Enrollment in a clinical trial not approved for co-enrollment
9. Any condition that, in the Principal Investigator or treating physician's opinion, makes the patient unsuitable for study participation

Contacts and Locations

Principal Investigator

Parag Goyal, MD, MSc

PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Study Locations (Sites)

Weill Cornell Medicine

New York, New York, 10065

United States

Collaborators and Investigators

Sponsor: Weill Medical College of Cornell University

Parag Goyal, MD, MSc, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-07

Study Completion Date2026-07

Study Record Updates