Clinical Feasibility of Cardiac Neuromodulation Therapy for Heart Failure With Preserved Ejection Fraction
Clinical Feasibility of Cardiac Neuromodulation Therapy (CNT) as Treatment for HFpEF
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Ziv Belsky
- Numéro de téléphone: 201-691-4240
- E-mail: zbelsky@orchestrabiomed.com
Lieux d'étude
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Tbilisi, Géorgie
- Tbilisi Heart And Vascular Clinic
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Tbilisi, Géorgie
- Georgian Medical Research Clinic Healthycore
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Cardiac Output During Supine Exercise
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in 24-Hour Ambulatory Systolic Blood Pressure
Délai: 3 months
|
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
Délai: 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.
|
3-months
|
|
Change in Office Blood Pressure Measurements
Délai: 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
Délai: 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
Délai: 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).
|
Baseline through study end, an average of 1 year
|
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Change in Six-Minute Walk Distance
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CS-11
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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