Clinical Feasibility of Cardiac Neuromodulation Therapy for Heart Failure With Preserved Ejection Fraction
Clinical Feasibility of Cardiac Neuromodulation Therapy (CNT) as Treatment for HFpEF
연구 개요
상태
상세 설명
This study is a pilot, open-label, non-randomized feasibility investigation of Cardiac Neuromodulation Therapy (CNT) in patients with high blood pressure and heart failure who are indicated for dual-chamber pacemaker implantation or replacement. The purpose of the study is to assess the feasibility of applying CNT and to evaluate its effects on blood pressure, heart failure status, and cardiac function at rest and during exercise over a follow-up period of up to 12 months. Eligible participants who provide informed consent and meet all inclusion and exclusion criteria will receive implantation of the Moderato Plus device. Following implantation, participants will complete scheduled study visits including two baseline visits and follow-up visits at approximately 3, 6, and 12 months. Study assessments may include blood pressure measurements, New York Heart Association (NYHA) functional class, echocardiographic evaluations, laboratory biomarkers, functional exercise testing, and patient-reported outcome questionnaires. At selected visits, cardiac performance during rest and standardized exercise conditions will be assessed to compare responses with CNT therapy activated and deactivated according to a predefined protocol. These comparisons are intended to evaluate short-term physiological responses to CNT and support feasibility assessments.
The first group of enrolled participants will undergo initial study assessments prior to long-term CNT activation to confirm the feasibility and appropriateness of the evaluation procedures. Based on this review, the study will continue as planned. Upon completion of the study follow-up, CNT therapy will be discontinued, and participants will resume standard clinical care.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Ziv Belsky
- 전화번호: 201-691-4240
- 이메일: zbelsky@orchestrabiomed.com
연구 장소
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Tbilisi, 그루지야
- Tbilisi Heart and Vascular Clinic
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Tbilisi, 그루지야
- Georgian Medical Research Clinic Healthycore
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Adults aged 18 years or older
- Clinical indication for dual-chamber pacemaker implantation or replacement
- Diagnosis of heart failure with preserved ejection fraction (HFpEF), defined as left ventricular ejection fraction ≥50%
- History of hypertension
- NYHA functional class II or III
- On stable guideline-directed medical therapy
- Able and willing to provide written informed consent
Exclusion Criteria:
- NYHA class IV heart failure
- Permanent or persistent atrial fibrillation
- Recent acute decompensated heart failure
- Significant valvular heart disease requiring intervention
- Severe comorbid conditions that, in the investigator's judgment, would make study participation unsafe
- Pregnant or breastfeeding individuals
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Cardiac Neuromodulation Therapy
Participants receive the Moderato Plus device with Cardiac Neuromodulation Therapy
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Moderato Plus System with CNT
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Cardiac Output During Supine Exercise
기간: 6-months
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Cardiac output measured during supine rest and graded supine bicycle exercise using thermodilution techniques, with CNT activated and deactivated, at baseline and at 6 months.
Results will be summarized as the change in cardiac output during exercise between baseline and follow-up.
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6-months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in 24-Hour Ambulatory Systolic Blood Pressure
기간: 3 months
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Change in average 24-hour systolic blood pressure measured by ambulatory blood pressure monitoring (ABPM), comparing baseline and the 3-month visit.
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3 months
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Change in Daytime and Nighttime Ambulatory Systolic Blood Pressure
기간: 3-months
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Change in average daytime and nighttime systolic blood pressure measured by 24-hour ambulatory blood pressure monitoring (ABPM), comparing baseline and the 3-month visit.
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3-months
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Change in Office Blood Pressure Measurements
기간: through study end, an average of 1 year
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Change in office-based systolic and diastolic blood pressure measurements at each study visit compared to baseline.
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through study end, an average of 1 year
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Change in NYHA Functional Class
기간: at 3 months and 12 months
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Change in New York Heart Association (NYHA) functional classification assessed at Visits 4 (3 months) and 6 (12 months) compared with baseline.
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at 3 months and 12 months
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Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Score Overall Summary Score
기간: Baseline through study end, an average of 1 year
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Change in patient-reported health status as measured by the 23-item Kansas City Cardiomyopathy Questionnaire (KCCQ-23) Overall Summary Score, comparing follow-up assessments with baseline values.
The KCCQ-23 is a validated, disease-specific instrument consisting of 23 items, with scores ranging from 0 to 100, where higher scores indicate better health status (fewer symptoms and physical and social limitations).
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Baseline through study end, an average of 1 year
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Change in Six-Minute Walk Distance
기간: Baseline through study end
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Change in functional exercise capacity as measured by the six-minute walk test, comparing follow-up assessments with baseline.
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Baseline through study end
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Change in NT-proBNP Levels
기간: Baseline through study end, an average of 1 year
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Change in plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels measured at follow-up compared with baseline.
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Baseline through study end, an average of 1 year
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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