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

Primary Purpose

Cardiac Conduction System, His Bundle Pacing, Heart Failure

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
High Intensity His Bundle pacing
Sponsored by
Miulli General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Conduction System focused on measuring His bundle pacing, conduction system pacing, Heart failure, Cardiomyopathy, narrow QRS, Ejection Fraction

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged 18 or above
  • Ventricular Ejection Fraction (EF) < 50%; BNP needs to be ≥250ng/L or N Terminal-pro BNP≥600ng/L for patients with EF 36-50% and they should have an ICD indication
  • New York Heart Association (NYHA) class I-IV
  • Narrow QRS duration (≤110ms) on 12 lead ECG

Exclusion Criteria:

  • Other serious medical condition with life expectancy of less than 1 year
  • Lack of capacity to consent
  • Pregnancy

Sites / Locations

  • Miulli General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

High intensity His bundle pacing

Back up only ventricular pacing

Arm Description

After implantation of the device there will be a 1-month run-in period that the device will be programmed to deliver His bundle pacing therapy during this period at 3.5V/1msec. After one month these patients will continue to receive active pacing treatment with 3.5V/1msec.

After implantation of the device there will be a 1-month run-in period that the device will be programmed to deliver His bundle pacing therapy during this period at 2V/1msec. After one month these patients will receive back up only pacing (pacemaker programmed to VVI 30 bpm or AAI(R)-DDD(R) 50bpm) for 6 months.

Outcomes

Primary Outcome Measures

Change in left ventricular ejection fraction
change in left ventricular ejection fraction measured by 2D echo at 6 months compared to baseline

Secondary Outcome Measures

Changes in B-type Natriuretic Peptide (BNP)
Measured from blood samples
Changes in Quality of Life (QOL) Scores
Change in QOL measured by the Kansas City Cardiomyopathy Questionnaire at 1 and 6 months compared to baseline. Scores are scaled 0-100, where 0 denotes the lowest reportable health status and 100 the highest
Changes in arrhythmia burden
Measured during Pacemaker control

Full Information

First Posted
August 4, 2022
Last Updated
October 15, 2023
Sponsor
Miulli General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05491655
Brief Title
High Intensity His Bundle Pacing in Heart Failure Patients With Narrow QRS Outcome Study
Acronym
HIPPOS
Official Title
High Intensity His Bundle Pacing in Heart Failure Patients With Narrow QRS Outcome Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 29, 2023 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Miulli General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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 multi-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.
Detailed Description
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 Right Bundle Branch Block (RBBB) through atrioventricular (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 multi-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. All patients will be implanted with a CRT (Cardiac Resynchronization Therapy) defibrillator with one of the leads positioned on the His bundle to obtain direct His-bundle capture. (There will be a 1-month run-in period where the output voltage will be 3.5 Volts/1 or 2V/1msec according to the group so as to obtain stable threshold). A single-blinded cross-over design will then be employed to investigate the effect of His bundle pacing. Patients will be allocated in random order to six-month treatment periods in each of the following two states (1) 3.5 Volts/1 msec pacing output direct His-bundle pacing, AV delay will be programmed in order to obtain a PR interval of 120-140msec; (2)back up only pacing (pacemaker programmed to VVI 30 bpm). Endpoint measurements will be taken at baseline, 1 month run-in period of 3.5 Volts/1 msec or 2V/1msec pacing output and 6 months post randomization. Treating Physicians will be aware of assignment in order to facilitate routine device follow-up. Echocardiographic and electrocardiographic evaluation will be performed in a blinded manner. Treatment allocation will be blinded to the endpoint assessor and the patient. Patients entering the study will attend for implantation of a CRT pacemaker device with one lead positioned on the His bundle. This will be performed in Miulli General Hospital (and other participating centres) no later than 2 months after the patient's screening visit. Before the intervention patients will be randomized to either receive active pacing treatment with 3.5 V/1 msec or back up only pacing (pacemaker programmed to VVI 30 bpm) for 6 months. All patients will be implanted with an Implantable cardioverter defibrillator (ICD) and an ICD lead in the right ventricle (RV) (either RV apex or RV septum). In all patients a pacing lead will be positioned in the right atrium (typically the right atrial appendage). All patients will have a pacemaker lead positioned on the His bundle to obtain direct His-bundle capture. After implantation of the device there will be a 1-month run-in period that the device will be programmed to deliver His bundle pacing therapy during this period at 3.5 Volts/1msec or 2V/1msec according to the assignment group. One month after patients are implanted with their device, patients will either receive active pacing treatment with 3.5 V/1 msec or back up only pacing (pacemaker programmed to VVI 30 bpm) for 6 months. Treatment allocation will be obtained using an Interactive Web Response System (IWRS) programmed with a randomization schedule provided by the trial statistician. Appropriate blocking will be used.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Conduction System, His Bundle Pacing, Heart Failure, Cardiomyopathies
Keywords
His bundle pacing, conduction system pacing, Heart failure, Cardiomyopathy, narrow QRS, Ejection Fraction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Subjects will be blinded to treatment arm. Echocardiographic evaluation will be performed by study physician blinded to lead placement
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High intensity His bundle pacing
Arm Type
Experimental
Arm Description
After implantation of the device there will be a 1-month run-in period that the device will be programmed to deliver His bundle pacing therapy during this period at 3.5V/1msec. After one month these patients will continue to receive active pacing treatment with 3.5V/1msec.
Arm Title
Back up only ventricular pacing
Arm Type
Sham Comparator
Arm Description
After implantation of the device there will be a 1-month run-in period that the device will be programmed to deliver His bundle pacing therapy during this period at 2V/1msec. After one month these patients will receive back up only pacing (pacemaker programmed to VVI 30 bpm or AAI(R)-DDD(R) 50bpm) for 6 months.
Intervention Type
Device
Intervention Name(s)
High Intensity His Bundle pacing
Intervention Description
All patients will be implanted with an Implantable cardioverter defibrillator (ICD) and an ICD lead in the right ventricle (either RV apex or RV septum). In all patients a pacing lead will be positioned in the right atrium (typically the right atrial appendage). All patients will have a pacemaker lead positioned on the His bundle to obtain direct His-bundle capture.
Primary Outcome Measure Information:
Title
Change in left ventricular ejection fraction
Description
change in left ventricular ejection fraction measured by 2D echo at 6 months compared to baseline
Time Frame
Baseline pre-intervention, randomisation and 6 months post randomisation
Secondary Outcome Measure Information:
Title
Changes in B-type Natriuretic Peptide (BNP)
Description
Measured from blood samples
Time Frame
Baseline pre-intervention, randomisation and 6 months post randomisation
Title
Changes in Quality of Life (QOL) Scores
Description
Change in QOL measured by the Kansas City Cardiomyopathy Questionnaire at 1 and 6 months compared to baseline. Scores are scaled 0-100, where 0 denotes the lowest reportable health status and 100 the highest
Time Frame
Baseline pre-intervention,1 and 6 months post randomisation
Title
Changes in arrhythmia burden
Description
Measured during Pacemaker control
Time Frame
1 month and 6 months post randomization.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18 or above Ventricular Ejection Fraction (EF) < 50%; BNP needs to be ≥250ng/L or N Terminal-pro BNP≥600ng/L for patients with EF 36-50% and they should have an ICD indication New York Heart Association (NYHA) class I-IV Narrow QRS duration (≤110ms) on 12 lead ECG Exclusion Criteria: Other serious medical condition with life expectancy of less than 1 year Lack of capacity to consent Pregnancy Previous aortic valve surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Grigorios Katsouras, MD, MSc
Phone
0803054219
Email
g.katsouras@miulli.it
First Name & Middle Initial & Last Name or Official Title & Degree
Pietro Guida
Phone
0803054029
Email
p.guida@miulli.it
Facility Information:
Facility Name
Miulli General Hospital
City
Acquaviva Delle Fonti
State/Province
Bari
ZIP/Postal Code
70021
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grigorios Katsouras, MD, MSc
Phone
0803054219
Email
gkatsouras@me.com
First Name & Middle Initial & Last Name & Degree
Piero Guida
Phone
0803054029
Email
p.guida@miulli.it

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15152059
Citation
Bristow MR, Saxon LA, Boehmer J, Krueger S, Kass DA, De Marco T, Carson P, DiCarlo L, DeMets D, White BG, DeVries DW, Feldman AM; Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) Investigators. Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. N Engl J Med. 2004 May 20;350(21):2140-50. doi: 10.1056/NEJMoa032423.
Results Reference
background
PubMed Identifier
31078637
Citation
Upadhyay GA, Vijayaraman P, Nayak HM, Verma N, Dandamudi G, Sharma PS, Saleem M, Mandrola J, Genovese D, Tung R; His-SYNC Investigators. His Corrective Pacing or Biventricular Pacing for Cardiac Resynchronization in Heart Failure. J Am Coll Cardiol. 2019 Jul 9;74(1):157-159. doi: 10.1016/j.jacc.2019.04.026. Epub 2019 May 9. No abstract available.
Results Reference
background
PubMed Identifier
23900696
Citation
Cleland JG, Abraham WT, Linde C, Gold MR, Young JB, Claude Daubert J, Sherfesee L, Wells GA, Tang AS. An individual patient meta-analysis of five randomized trials assessing the effects of cardiac resynchronization therapy on morbidity and mortality in patients with symptomatic heart failure. Eur Heart J. 2013 Dec;34(46):3547-56. doi: 10.1093/eurheartj/eht290. Epub 2013 Jul 29.
Results Reference
background
PubMed Identifier
36404397
Citation
Whinnett ZI, Shun-Shin MJ, Tanner M, Foley P, Chandrasekaran B, Moore P, Adhya S, Qureshi N, Muthumala A, Lane R, Rinaldi A, Agarwal S, Leyva F, Behar J, Bassi S, Ng A, Scott P, Prasad R, Swinburn J, Tomson J, Sethi A, Shah J, Lim PB, Kyriacou A, Thomas D, Chuen J, Kamdar R, Kanagaratnam P, Mariveles M, Burden L, March K, Howard JP, Arnold A, Vijayaraman P, Stegemann B, Johnson N, Falaschetti E, Francis DP, Cleland JGF, Keene D. Effects of haemodynamically atrio-ventricular optimized His bundle pacing on heart failure symptoms and exercise capacity: the His Optimized Pacing Evaluated for Heart Failure (HOPE-HF) randomized, double-blind, cross-over trial. Eur J Heart Fail. 2023 Feb;25(2):274-283. doi: 10.1002/ejhf.2736.
Results Reference
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High Intensity His Bundle Pacing in Heart Failure Patients With Narrow QRS Outcome Study

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