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Clinical Feasibility of Cardiac Neuromodulation Therapy for Heart Failure With Preserved Ejection Fraction

14. maj 2026 opdateret af: BackBeat Medical Inc

Clinical Feasibility of Cardiac Neuromodulation Therapy (CNT) as Treatment for HFpEF

This is an open-label pilot study to evaluate the feasibility of Cardiac Neuromodulation Therapy (CNT) in patients with high blood pressure and heart failure who require dual-chamber pacemaker implantation or replacement. The study will assess blood pressure and heart function at rest and during exercise, with and without CNT, for up to 12 months. Participants will receive the Moderato Plus device and complete scheduled follow-up visits. After study completion, CNT therapy will be discontinued and participants will return to standard medical care.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Georgien
      • Tbilisi, Georgien
        • Tbilisi Heart and Vascular Clinic
      • Tbilisi, Georgien
        • Georgian Medical Research Clinic Healthycore

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Cardiac Neuromodulation Therapy
Participants receive the Moderato Plus device with Cardiac Neuromodulation Therapy
Enhed: Moderato Plus device with Cardiac Neuromodulation Therapy
Moderato Plus System with CNT

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Cardiac Output During Supine Exercise
Tidsramme: 6-months
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.
6-months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in 24-Hour Ambulatory Systolic Blood Pressure
Tidsramme: 3 months
Change in average 24-hour systolic blood pressure measured by ambulatory blood pressure monitoring (ABPM), comparing baseline and the 3-month visit.
3 months
Change in Daytime and Nighttime Ambulatory Systolic Blood Pressure
Tidsramme: 3-months
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
Tidsramme: through study end, an average of 1 year
Change in office-based systolic and diastolic blood pressure measurements at each study visit compared to baseline.
through study end, an average of 1 year
Change in NYHA Functional Class
Tidsramme: at 3 months and 12 months
Change in New York Heart Association (NYHA) functional classification assessed at Visits 4 (3 months) and 6 (12 months) compared with baseline.
at 3 months and 12 months
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Score Overall Summary Score
Tidsramme: Baseline through study end, an average of 1 year
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
Change in Six-Minute Walk Distance
Tidsramme: Baseline through study end
Change in functional exercise capacity as measured by the six-minute walk test, comparing follow-up assessments with baseline.
Baseline through study end
Change in NT-proBNP Levels
Tidsramme: Baseline through study end, an average of 1 year
Change in plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels measured at follow-up compared with baseline.
Baseline through study end, an average of 1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

BackBeat Medical Inc

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

30. maj 2026

Primær færdiggørelse (Anslået)

30. maj 2028

Studieafslutning (Anslået)

30. november 2028

Datoer for studieregistrering

Først indsendt

21. april 2026

Først indsendt, der opfyldte QC-kriterier

14. maj 2026

Først opslået (Faktiske)

20. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CS-11

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