Cardiac Contractility Modulation (CCM) and Implementation of Guideline-Directed Medical Therapy in Patients With Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Change in Quad Medication Score
研究概览
简要总结
The primary objective of this study is to evaluate the impact of Cardiac Contractility Modulation (CCM) therapy on the initiation and up-titration of Guideline-Directed Medical Therapy (GDMT) in patients with heart failure (HF). This will be assessed by the change in Quad Medication Score (QMS) from baseline (pre-CCM) to 6-month following post-CCM device implant.
详细描述
Design Prospective, non-randomized, comparison analysis of medication use and dosing at pre/post CCM therapy. The Fix-GDMT-HF study aims to enroll up to 200 subjects (100 in Investigational Arm and up to 100 in Registry Arm). Subjects identified not eligible to participate in the investigational arm can participate in the registry arm.
Method
- Subjects with QMS ≤ 5, eGFR ≥15, diagnosed symptomatic heart failure and LVEF ≤40% will be enrolled after review and approval by a member of the steering committee. Eligible subjects will receive CCM therapy and be enrolled in the investigational arm of the study. Medication optimization(Med op#2) will be assessed after implantation(approx. 3month post implant), followed by evaluation of QMS and other endpoints at 6 and 12 months. A target of 100 patients will be enrolled in the investigational arm.
- After medical optimization (Med op# 1), if the patient has QMS > 5 or identified during SC review as not eligible to participate in investigational arm can participate in the registry arm. They will continue treatment guided by local practice (including potential CCM implant) with QMS assessment (and other data collection as patients in investigational arm) at 6- and 12-month visit. The registry arm will be restricted to 100 patients.
Endpoints
Primary Endpoint:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Adults (≥18 years) diagnosed with symptomatic heart failure
- •Patients with Heart failure with reduced Ejection Fraction (HFrEF) where the Ejection Fraction (EF) is ≤40%
- •Historical LVEF assessed up to 6 months prior to consent by any modality can be used if available
- •Patients can have an active concomitant CRT device already - implanted provided the following criteria:
- •CRT device has been implanted >1 year
- •Patients are functional class NYHA III-IV
排除标准
- •Patients that are unlikely to adhere to medical therapy for reasons other than intolerance or contraindications.
- •Patients with a QMS score >5
- •Patients with a concomitant CRT device that has already been implanted and deemed to be a responder
- •Patients with class I indication for a concomitant CRT device
- •Patients with significant comorbidities or conditions that may interfere with the study assessments
- •Patients with contraindications to CCM therapy or unable to undergo implantation
- •Severe stenotic valve disease
结局指标
主要结局
Change in Quad Medication Score
时间窗: 6 month
Change in the Quad Medication Score (QMS) from baseline (pre-CCM) to 6-month follow-up (post-CCM) of the Optimizer device implant
次要结局
- Change in loop diuretic dose(6-month)
- Change in eGFR(6-month)
- Change in SBP(6-month)
- Adverse events (AEs) associated with CCM therapy.(12-month)
- Percentage of patients achieving maximal/optimal GDMT following CCM therapy(12-month)
- GDMT adherence as measured by change in QMS score(12-month)