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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG091005 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| Kaiser Foundation Research Institute | OTHER |
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The goal of this study is to learn whether stopping beta-blockers can help older adults with heart failure with preserved ejection fraction (HFpEF) feel better and function better. This study will test whether "deprescribing" or stopping these medications in a careful, guided way can improve symptoms and quality of life.
Participants will be randomly assigned to one of two groups:
Deprescribing group: Beta-blockers are gradually reduced using capsules that contain decreasing doses.
Usual care group: Beta-blockers are continued at the usual dose in look-alike capsules.
All participants will:
This study does not involve any experimental medication. Participants active involvement in the study will last approximately 4 months. During these 4 months they will have 8 scheduled telephone visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deprescribe | Placebo Comparator | Participants will have their beta-blocker replaced with pills that have decreasing amounts of beta-blocker until they are completely off their medicine and taking placebo pills. |
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| Continuation | Active Comparator | Participants will continue their beta-blocker at their usual dose in capsules that look identical to those used for the deprescribe arm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo (matching) | Drug | Beta-blocker dosage will be reduced over the course of 4 weeks until the participant is completely off of beta-blocker and transitioned to matching placebo capsules. |
| Measure | Description | Time Frame |
|---|---|---|
| The Hierarchical Composite Endpoint | The primary outcome is net benefit, assessed using a hierarchical composite of four patient-centered outcomes: (1) time to death from any cause, (2) time to all-cause hospitalization, (3) ≥ 5-point difference of KCCQ-12 OSS change from baseline, and (4) ≥ 3-point difference in PROMIS Depression T-score change from baseline | From baseline (day 0) to end of the follow-up phase (day 120) |
| Measure | Description | Time Frame |
|---|---|---|
| The change from baseline in patient-reported physical health, as measured by the KCCQ-12 | The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a heart failure-specific health status survey. The 12-item questionnaire asks participants to rate their agreement with a series of statements using a six-point Likert scale, ranging from "completely disagree" (0) to "completely agree" (5). Item responses are summed to generate a total score ranging from 0 to 100, with higher scores indicating better health status. |
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Inclusion Criteria:
Exclusion Criteria:
Alternative etiologies of HFpEF syndrome
Compelling guideline indication for ß-blocker:
Evidence of recent decompensated HF
Estimated life expectancy <6 months (i.e., diagnostic codes)
Diagnosed dementia (i.e.., diagnostic codes)
Unable to provide informed consent
Loss of Kaiser Permanence Northern California Membership
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| Name | Affiliation | Role |
|---|---|---|
| Parag Goyal, MD, MSc | Weill Medical College of Cornell University | Principal Investigator |
| Andrew Ambrosy, MD, MPH | Kaiser Permanente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Northern California (KPNC) | Pleasanton | California | 94588 | United States |
Data collected for this study will be shared only after the publication of findings addressing the study's specific aims. Data generated under this project will be managed in accordance with the policies of Weill Cornell Medicine (WCM) and the NIH, including the NIH Data Sharing Policy and Implementation Guidance. After publication of our main findings, data will be made available for secondary analyses. External researchers may request access to the data by submitting a written proposal outlining the hypotheses to be tested. All data will be de-identified to protect participant confidentiality.
The data will be shared after we have published the primary results of this study. There is no end date to access the data from the research project.
Researchers granted access to the data will be required to use it solely for research purposes, ensuring that no individual participants are identifiable. They must also implement appropriate security measures, such as using password-protected servers and files, to safeguard the data. Upon completion of the analyses, the data must be returned or destroyed. Released datasets will be subject to stringent safeguards to ensure compliance with the Health Insurance Portability and Accountability Act (HIPAA). Additionally, a data-sharing agreement will be required, specifying that the data is used exclusively for research purposes and that no participants are identifiable. Any additional approvals required by participating institutions, including KPNC, will be obtained. A data management plan will also be necessary to ensure the continued security and confidentiality of the data, as well as to outline the process for returning or destroying the data once the analysis is complete.
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| Beta-blockers | Drug | Participants will continue their pre-enrollment beta-blocker at the same dose. The beta-blocker agent may include atenolol, bisoprolol, carvedilol, metoprolol succinate, or metoprolol tartrate. Medication will be provided in matching capsules to maintain blinding. |
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| Baseline, Day 120 |
| The change in patient-reported mental health, as measured by the PROMIS Depression scale | The PROMIS Depression scale is a validated 4-item patient-reported measure developed by the NIH, with high reliability and responsiveness in older adults. The 4-item questionnaire asks participants to rate their agreement with a series of statements using a six-point Likert scale, ranging from "never" (0) to "always" (5). Item responses are summed to generate a raw score ranging from 4 to 20, which is then converted to a standardized T-score using PROMIS scoring guidelines. Higher scores indicate greater depressive symptom severity. | Baseline, Day 120 |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000069340 | Deprescriptions |
| D000319 | Adrenergic beta-Antagonists |
| D001262 | Atenolol |
| D017298 | Bisoprolol |
| D000077261 | Carvedilol |
| D008790 | Metoprolol |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D018674 | Adrenergic Antagonists |
| D018663 | Adrenergic Agents |
| D018377 | Neurotransmitter Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045505 | Physiological Effects of Drugs |
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |
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