Determining Evidence in a Placebo-Controlled, Randomized Experiment Studying Continuation vs. Removal of Inessential Beta-Blockers in Elders With Heart Failure With Preserved Ejection Fraction (DEPRESCRIBE-HFpEF)
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- The Hierarchical Composite Endpoint
研究概览
简要总结
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:
- Take study medicine for about 4 months
- Have their blood pressure and heart rate monitored
- Complete regular phone calls and questionnaires about how they are feeling
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ambulatory adults age ≥60 years with HFpEF (EF ≥50% based on most recent transthoracic echocardiogram)
- •Hospitalized with HF in the past 24 months (defined by diagnostic codes in any position)
- •Taking any of the following ß-blockers: atenolol, bisoprolol, carvedilol, metoprolol succinate, or metoprolol tartrate (i.e., pharmacy prescription data)
- •Kaiser Permanence Northern California Membership
排除标准
- •Alternative etiologies of HFpEF syndrome
- •Compelling guideline indication for ß-blocker:
- •Prior EF <50% (i.e., based on the structured data field on transthoracic echocardiogram)
- •Current anginal symptoms (i.e., based on the Rose Angina single-question screener for angina)
- •MI (i.e., diagnostic codes) and/or coronary revascularization (i.e., procedure codes) within 3 years
- •Hospitalization for a primary discharge diagnosis of atrial fibrillation or atrial flutter in the prior 12 months
- •Other documented reason in the opinion of the treating provider and/or enrolling clinician-investigator
- •Evidence of recent decompensated HF
- •Hospitalization for a primary discharge diagnosis of HF within the past 30 days
- •Change in loop diuretic pharmacy prescription in the past 30 days (i.e. pharmacy prescription data) (Note: This definition is based on documented prescription changes and does not include short-term dose adjustments that were verbally communicated to the patient by their provider.)
- •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
研究组 & 干预措施
Deprescribe
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.
干预措施: Placebo (matching) (Drug)
Continuation
Participants will continue their beta-blocker at their usual dose in capsules that look identical to those used for the deprescribe arm.
干预措施: Beta-blockers (Drug)
结局指标
主要结局
The Hierarchical Composite Endpoint
时间窗: From baseline (day 0) to end of the follow-up phase (day 120)
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
次要结局
- The change from baseline in patient-reported physical health, as measured by the KCCQ-12(Baseline, Day 120)
- The change in patient-reported mental health, as measured by the PROMIS Depression scale(Baseline, Day 120)