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Pacing for Heart Failure With Preserved Ejection Fraction (HFpEF)

29. mai 2013 oppdatert av: Medtronic Cardiac Rhythm and Heart Failure
The purpose of this research study is to evaluate the safety of a new pacing method (Fusion Pacing) for heart failure patients with an ejection fraction (EF) greater than 50% over a period of 4 months, and determine the effects on different measures of heart failure. This new pacing method may allow the heart to pump more efficiently. Participation in this study will last approximately 8 months.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Patients with an EF greater than 50% and a regional mechanical delay of >= 65ms (an indication of mechanical dyssynchrony) will receive an implantable cardioverter defibrillator (ICD) with a special pacing feature. When the feature is active, the device wil pace the left ventricle to target improved pump efficiency. Patients will have the feature active for 4 months and inactive for 4 months. The order will be randomized and the patient will not know whether the pacing is active or not. Echocardiography, biomarkers, exercise testing, quality of life (QOL) testing and device information will be used to compare the patient's status while the feature is active vs. inactive.

Studietype

Intervensjonell

Registrering (Faktiske)

22

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Belgia
      • Aalst, Belgia
  • Taiwan
      • Taipei, Taiwan
        • National Taiwan University Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Patients with quantitative ejection fraction (EF) of greater than 50 percent
  • Patients with active heart failure (symptomatic American Heart Association/American College of Cardiology stage C) despite optimal medications
  • Patients greater than 18 years of age
  • Patients willing and able to give informed consent
  • Patients available for appropriate follow-up times for the length of study
  • Patients able to complete cardiopulmonary exercise (CPX) testing
  • Patients expected lifespan is greater than 12 months beyond study enrollment
  • Patients with a regional mechanical delay (RMD) (septal-lateral) greater than 65 milliseconds

Exclusion Criteria:

  • Patients who have undergone cardiac surgery 60 days prior to enrollment
  • Patients who have had a myocardial infarction 90 days prior to enrollment
  • Patients with hemodynamically significant uncorrected cardiac valvular disease
  • Patients with active myocarditis and amyloidosis (if documented)
  • Patients with a permanent pacemaker
  • Patients with creatinine greater than 2 milligrams per milliliter or estimated glomerular filtration rate (eGFR) less than 30 to 50 milliliters per hour
  • Patients with permanent or chronic sustained atrial fibrillation (fibrillation lasting 7 days or more at a time)
  • Patients with a PR interval greater than 250 milliseconds
  • Patients with severe chronic obstructive pulmonary disease
  • Patients with high risk coronary artery disease
  • Patients who are or expect to become pregnant during this study
  • Patients enrolled in concurrent studies which could confound the results of this study
  • Patients with hypertrophic cardiomyopathy (obstructive or non-obstructive)
  • Patients with infiltrative disease or restrictive cardiomyopathy
  • Patients with indication for percutaneous coronary intervention (PCI) at enrollment

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Fusion Pacing OFF
Subjects initially randomized to the Fusion Pacing OFF Arm will receive the Fusion Pacing software download at the implant visit, but the Fusion Pacing software will be programmed OFF. At 4 months subjects in this arm will crossover to the Fusion Pacing ON Arm.
Enhet: Cardiac Resynchronization Therapy-Defibrillator (CRT-D)
Market approved InSync Sentry™ model 7298, dual chamber Implantable Cardioverter Defibrillator (ICD) with Cardiac Resynchronization Therapy (CRT) including sequential biventricular pacing and OptiVol® fluid monitoring or market approved InSync Maximo™ model 7304 dual chamber ICD with CRT including sequential biventricular pacing.
Andre navn:
  • Fusion Pacing Investigational Software
  • Fusion Pacing is an algorithm that is downloaded for use in InSync Sentry™ or InSync Maximo™ devices.
Eksperimentell: Fusion Pacing ON
Subjects initially randomized to the Fusion Pacing ON Arm will receive the Fusion Pacing software download at the implant visit, and the Fusion Pacing software will be programmed ON. At 4 months subjects in this arm will crossover to the Fusion Pacing OFF Arm.
Enhet: Cardiac Resynchronization Therapy-Defibrillator (CRT-D)
Market approved InSync Sentry™ model 7298, dual chamber Implantable Cardioverter Defibrillator (ICD) with Cardiac Resynchronization Therapy (CRT) including sequential biventricular pacing and OptiVol® fluid monitoring or market approved InSync Maximo™ model 7304 dual chamber ICD with CRT including sequential biventricular pacing.
Andre navn:
  • Fusion Pacing Investigational Software
  • Fusion Pacing is an algorithm that is downloaded for use in InSync Sentry™ or InSync Maximo™ devices.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Number of adverse events while the Fusion Pacing download is active vs. inactive.
Tidsramme: From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
Percentage of time the Fusion Pacing is active throughout a four-month follow-up period.
Tidsramme: From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit

Sekundære resultatmål

Resultatmål
Tidsramme
Change in Minnesota Living with Heart Failure Questionnaire score.
Tidsramme: From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
Change in peak VO2 during Cardio-pulmonary Exercise Testing (CPX).
Tidsramme: From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
Change in echocardiography measures: E/E', Ejection Fraction, LV EDV.
Tidsramme: From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
Change in NT-proBNP.
Tidsramme: From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Etterforskere

  • Studiestol: HFpEF Trial Leader, Medtronic

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juni 2010

Primær fullføring (Faktiske)

1. januar 2013

Studiet fullført (Faktiske)

1. januar 2013

Datoer for studieregistrering

Først innsendt

8. januar 2010

Først innsendt som oppfylte QC-kriteriene

8. januar 2010

Først lagt ut (Anslag)

11. januar 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

30. mai 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. mai 2013

Sist bekreftet

1. mai 2013

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • MDT0095101

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