NCT05906745已完成不适用
Guideline Directed Medical Therapy (GDMT) Optimization and Adherence Longitudinal Study for Heart Failure. (GOALS-HF)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 4
- 主要终点
- NT-ProBNP
研究概览
简要总结
A multicenter, non-randomized prospective longitudinal study to evaluate the feasibility of Tricog's Remote platform for Guideline Directed Medical Therapy (GDMT) titration and remote patient monitoring among patients with Heart Failure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Recent hospitalization (within 4 weeks of enrollment) for HF with IV diuretic use
- •Echocardiographic data with EF measurements available in the last 6 months and after HF diagnosis
- •Established outpatient care at the participating sites
- •Eligible to receive at least 2 of the 4 GDMT classes (ACEi/ARB/ARNi, Beta-blockers, MRA, and SGLT2i) for HFrEF and HFmrEF and at least one of the three (ARB/ARNI, MRA, SGLT2i) for HFpEF
- •Not on Target GDMT for all the eligible GDMT classes
- •>12 months of expected survival
- •Comfortable with spoken and written English communication
- •Access to Apple Watch-compatible iPhone
排除标准
- •Under consideration for or recipient of advanced heart failure therapies (LVAD, Transplant)
- •Current or anticipated use of home intravenous inotrope therapy.
- •Unwilling or unable to perform all study related procedures (wear watch, take measurements and maintain daily logs)
- •Post-discharge placement in nursing, rehabilitation, or long-term care facility
- •Planned (within next 6 months) surgery
- •Inability to provide written consent
结局指标
主要结局
NT-ProBNP
时间窗: Baseline, week 2, 1-month follow-up, week 8, 3-month follow-up, week 16, week 20, 6-month follow-up
Serum level of N-terminal pro B-type natriuretic peptide
次要结局
- HF Hospitalizations(3-month, and 6-month follow-up)
- 6-min walk distance(Baseline, 1-month follow-up, 3-month, and 6-month follow-up)
- KCCQ Overall Summary Score(The survey will be assessed at baseline, 1-month, 3-month, and 6-month follow-up.)
- Atrial Fibrillation Anticoagulation Utilization(Baseline, 3-month, and 6-month)
- HFpEF Medication Utilization(Baseline, 1-month follow-up, 3-month, and 6-month follow-up)
- composite modified HF Collaboratory GDMT score(Baseline, 1-month follow-up, 3-month, and 6-month follow-up)
- Changes in Diuretic Dose(3-month, 6-month)
研究者
研究点 (4)
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