NCT05585125RecruitingPhase 4
A Preliminary Study for INFORMED
A Preliminary Study for the Intervention of an N-of-1 Protocol For Medication Optimization
Source: ClinicalTrials.gov · Last updated 21 Aug 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 18 (estimated)
- First submitted
- 11 Oct 2022
- Start date
- 7 Feb 2024
- Primary completion date
- Feb 2027
- Lead sponsor
- Weill Medical College of Cornell University
- Diseases
- Heart failure
- NCT number
- NCT05585125
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 18
- From 7 Feb 2024 to the primary completion date, Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Alternate cause(s) of HFpEF Syndrome:
- Severe aortic stenosis
- Moderate-severe mitral stenosis
- Constrictive pericarditis
- High output HF
- Infiltrative cardiomyopathy
- Moderate-severe dementia or psychiatric disorder precluding informed consent
- Any condition that, in the Principal Investigator or treating physician's opinion, makes the patient unsuitable for study participation
Other
- Estimated life expectancy \< 6 months
- 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
Who the study is looking for
- 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
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Weill Cornell Medicine Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.