Heart Failure Clinical Trial
— HIPPOSOfficial title:
High Intensity His Bundle Pacing in Heart Failure Patients With Narrow QRS Outcome Study
NCT number | NCT05491655 |
Other study ID # | MGH_003 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 29, 2023 |
Est. completion date | February 2025 |
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.
Status | Recruiting |
Enrollment | 34 |
Est. completion date | February 2025 |
Est. primary completion date | February 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Miulli General Hospital | Acquaviva Delle Fonti | Bari |
Lead Sponsor | Collaborator |
---|---|
Miulli General Hospital |
Italy,
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. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in left ventricular ejection fraction | change in left ventricular ejection fraction measured by 2D echo at 6 months compared to baseline | Baseline pre-intervention, randomisation and 6 months post randomisation | |
Secondary | Changes in B-type Natriuretic Peptide (BNP) | Measured from blood samples | Baseline pre-intervention, randomisation and 6 months post randomisation | |
Secondary | 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 | Baseline pre-intervention,1 and 6 months post randomisation | |
Secondary | Changes in arrhythmia burden | Measured during Pacemaker control | 1 month and 6 months post randomization. |
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