A Preliminary Study for INFORMED
Recruiting · NCT05585125 · Interventional (participants receive a specific treatment) · Lead sponsor: Weill Medical College of Cornell University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
Age range
65 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Ambulatory adults age ≥ 65 years with HFpEF, according to ACC/AHA guidelines (signs and symptoms of heart failure AND ejection fraction ≥ 50%)
- Taking beta-blocker
Exclusion criteria
- Alternate cause(s) of HFpEF Syndrome:
- Severe aortic stenosis
- Moderate-severe mitral stenosis
- Constrictive pericarditis
- High output HF
- Infiltrative cardiomyopathy
- Other compelling indication(s) for beta-blocker
- Prior EF \< 50%
- Hypertrophic cardiomyopathy
- Angina
- Acute coronary syndrome, myocardial infarction, or coronary artery bypass surgery in prior 3 years
- History of ventricular tachycardia/arrhythmia
- Atrial arrhythmia with hospitalization for rapid ventricular response, prior 1 year
- Heart rate \>100 bpm within the prior 3 months
- Atrial arrhythmia with ventricular rate \>90 per minute in the prior 3 months
- 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)
- Non-cardiac indications (e.g., migraine prevention, anxiety symptom management, hyperthyroidism, essential tumor reduction)
- Clinical instability (N-of-1 trials are appropriate for stable conditions only)
- Decompensated heart failure
- Hospitalization in the past 30 days
- Medication changes or procedures in the prior 14 days that could confound observations/data at PI discretion
- Anticipated medication changes or procedures in subsequent 3 months that could confound observations/data at PI discretion
- Clinical instability from other medical issues
- Estimated life expectancy \< 6 months
- Moderate-severe dementia or psychiatric disorder precluding informed consent
- Language barrier that will preclude informed consent and ability to comprehend study procedures
- Non-compliance or inability to complete study procedures
- Enrollment in a clinical trial not approved for co-enrollment
- Any condition that, in the Principal Investigator or treating physician's opinion, makes the patient unsuitable for study participation
Where it is running
1 location listed across 1 US state.
- Weill Cornell Medicine - New York, New York, United States