Clinical Feasibility of Cardiac Neuromodulation Therapy for Heart Failure With Preserved Ejection Fraction
Clinical Feasibility of Cardiac Neuromodulation Therapy (CNT) as Treatment for HFpEF
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Ziv Belsky
- Telefonní číslo: 201-691-4240
- E-mail: zbelsky@orchestrabiomed.com
Studijní místa
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Tbilisi, Gruzie
- Tbilisi Heart and Vascular Clinic
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Tbilisi, Gruzie
- Georgian Medical Research Clinic Healthycore
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Cardiac Output During Supine Exercise
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in 24-Hour Ambulatory Systolic Blood Pressure
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- CS-11
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