High Intensity His Bundle Pacing in Heart Failure Patients With Narrow QRS Outcome Study

Study acronym: HIPPOS
StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Trial completed Show 7 more changesShow less
    • Final enrollment: 40 participants (planned 34)
    • Primary completion date changed from estimate of Feb 2026 to Aug 1, 2026
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 1 of 3 entries
    • Study description revised
    • Site details revised
    • Publications: details revised at 4 of 5 entries
  2. Primary completion date: Feb 2025 to Feb 2026
    • Study completion date: Feb 2025 to May 2026
    • Publications: 4 to 5
    v8
  3. Study description expanded, about 8 wordsv7
  4. Publications: 3 to 4
    • Eligibility criteria expanded, about 4 words
    v6
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Feb 2023 to Mar 29, 2023
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Study description expanded, about 41 wordsv4
  2. Start date: Sep 2022 to Feb 2023v3
  3. Primary endpoint revised
    • Secondary endpoints revised (3)
    • Study description shortened, about 1 word
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Cardiac Resynchronization Therapy (CRT) decreases heart failure hospitalizations and mortality and increases left ventricular Ejection Fraction (EF) in patients with dilated cardiomyopathy, left bundle branch block and QRS duration \>130msec. His bundle pacing has a similar effect in this category of patients. However, CRT is not beneficial in heart failure (HF) patients with narrow QRS. His-bundle pacing delivers physiological ventricular activation and has been shown to improve acute hemodynamic function in patients with heart failure, a prolonged PR interval, and either a narrow QRS or RBBB through AV delay optimization. We observed an acute hemodynamic effect during application of higher pacing output (3.5 Volts/1 msec) in HF patients with dilated or ischemic cardiomyopathy and narrow QRS independently of the paced QRS duration or AV delay shortening. This is a single-center, prospective randomized single-blinded study, recruiting a sub-population of patients with heart failure (dilated or ischemic cardiomyopathy, EF\<50%, narrow QRS (\<110 msec), in optimal medical treatment who have an indication for ICD.
Trial Details
NCT Number NCT05491655
Lead Sponsor Miulli General Hospital
Conditions
(from sponsor)		 Cardiac Conduction System, His Bundle Pacing, Heart Failure, Cardiomyopathies
Related terms Arrhythmias, Cardiac, Cardiomyopathies, Heart Failure
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov