A Preliminary Study for INFORMED
A Preliminary Study for the Intervention of an N-of-1 Protocol For Medication Optimization
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 65 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Mentioned in the study description
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 6 weeks
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Off \[B\]) with up to 6 periods, each period lasting up to 6 weeks."
- Compensation
- Mentioned in the study description
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests a one-person-at-a-time approach to checking medicine use. It asks whether this helps adults age 65 or older with a type of heart failure called HFpEF feel more sure about whether to keep taking or stop beta-blockers.
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).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 65 or older and able to walk.
- Have signs and symptoms of HFpEF: heart failure where the heart still pumps out at least 50% of its blood with each beat.
- Currently take a beta-blocker medicine.
Who can't join
- Have another cause of heart failure, such as certain narrowed heart valves, a stiff sac around the heart, unusually high blood flow, or buildup of substances in the heart muscle.
- Need a beta-blocker for another heart problem: past pumping strength below 50%, thick heart muscle, chest pain from low blood flow, certain abnormal heart rhythms, or a heart attack, sudden loss of blood flow to the heart, or heart bypass surgery in the past 3 years.
- Have had a heart rate above 100 in the past 3 months; an abnormal rhythm in the upper heart chambers with a lower-chamber rate above 90 in that time; or a hospital stay for that rhythm with a fast lower-chamber rate in the past year.
- Have had a top blood pressure number above 160 in the past 3 months, unless it is high only at medical visits and below 140 at home; or need beta-blockers for a non-heart condition, such as migraine prevention, anxiety symptoms, or an overactive thyroid.
- Have worsening heart failure, another unstable health problem, or a hospital stay in the past 30 days. Medicine changes or procedures in the past 14 days or planned for the next 3 months may also rule you out if they could affect study results.
- Are expected to live less than 6 months, or have moderate to severe dementia or a mental health condition that prevents informed consent—understanding the study and agreeing to join.
- Cannot understand and agree to join because of a language barrier, cannot understand study steps, or cannot or do not follow study requirements.
- Are in another trial without approval to join both, or have any condition that the study leader or treating doctor believes makes this study unsuitable.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion 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 Exclusion Criteria: 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
Study sites (1)
NY
- Weill Cornell Medicine · New York, NY 10065Srikar Savaram, BS · Study contact · 646-962-7919 · srs4011@med.cornel.eduParag Goyal, MD, MSc · Principal investigatorMore trials in New York