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Resynchronization for Ambulatory Heart Failure Trial in Patients With Preserved LV Function

Primary Purpose

Heart Failure

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
CRT
Sponsored by
Anthony Tang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring LBBB, Medical Therapy, Sinus Rhythm, Preserved LV Function

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with NYHA class II-IVa HF symptoms and are on diuretic therapy
  • LVEF > 35% (stratify by LVEF 36-49% and LVEF ≥ 50%), and recovered LVEF (previously LVEF ≤ 35%, but improved to LVEF > 35% with medical therapy)
  • Patients with LVEF ≥ 40% must also have either left atrial volume index (LAVI) > 34 mL/m2 or LV mass index (LVMI) ≥ 115 g/m2 for males and ≥ 95 g/m2 for female
  • Sinus rhythm (can have paroxysmal atrial fibrillation)
  • LBBB and QRS duration ≥ 140 msec. for men or ≥ 130 msec. for women, and with mid-QRS notching or slurring in ≥ 2 leads
  • NT-proBNP ≥ 600 pg/ml or BNP level ≥ 120 pg/ml on stable medical therapy
  • Appropriate pharmacological treatment of HF and co-morbidities.
  • Stable diuretic and other HF medications for at least four weeks

Exclusion Criteria:

  • Patients with permanent atrial fibrillation
  • Patients with clinical indication for pacemaker or Implantable Cardioverter-Defibrillator
  • Serum creatinine >180 μmol/L; or estimated glomerular filtration rate [eGFR] ≤30 mL/min/1.73 m2, calculated using the Modification of Diet in Renal Disease formula
  • In-hospital patients with acute cardiac or non-cardiac illness that requires intensive care
  • Acute coronary syndrome (including MI) <4 weeks
  • Coronary revascularization (CABG or PCI) < 3 months
  • Uncorrected or uncorrectable primary valvular disease
  • TAVI < 3 months
  • Restrictive, or reversible form of cardiomyopathy, cardiac amyloidosis
  • Severe primary pulmonary disease such as cor pulmonale, primary pulmonary hypertension (may include secondary pulmonary hypertension, if mean pulmonary pressure is ≤ 70 mm Hg))
  • Expected to undergo cardiac transplantation within one year (status I)
  • Patients with a life expectancy of less than one year from non-cardiac cause.
  • Patients included in other clinical trials that will affect the objectives of this study
  • Those unable or unwilling to provide informed consent

Sites / Locations

  • London Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control Group

BiV-CRT

CS-CRT

Arm Description

The control group will be treated with practice guideline optimal medical therapy for HF.

The experimental group will be treated with CRT in addition to optimal medical therapy for HF. In addition, the trial will further compare two methods of delivering CRT. One experimental group will receive BiV-CRT, while the second experimental group will receive Conduction System(CS)-CRT.

The experimental group will be treated with CRT in addition to optimal medical therapy for HF. In addition, the trial will further compare two methods of delivering CRT. One experimental group will receive BiV-CRT, while the second experimental group will receive Conduction System(CS)-CRT.

Outcomes

Primary Outcome Measures

NTproBNP measurement
The co-primary outcome measure is NTproBNP as measured at 6 months.
6-minute walk distance
The co-primary outcome measure is 6 minute hall walk distance as measured at 6 months.
Quality of Life (QoL) score
The co-primary outcome measure is quality of life as measured using the Minnesota Living with Heart Failure Questionnaire (MLHFQ) score. The MLHFQ consists of 21 questions answered on a 0-5 likert scale, with higher scores indicating a stronger impact of heart failure on QoL.

Secondary Outcome Measures

Ventricular arrhythmia burden determined by the device capture of arrhythmias and adjudication by a device review committee blinded to patient's treatment allocation
The secondary outcome measure is Ventricular arrhythmia burden determined by the device as measured at 6 months.
LV reverse remodeling (LVESVi on echocardiography)
The secondary outcome measure is LV reverse remodeling as measured by LVESVi on echocardiography at 6 months.
LVEF
The secondary outcome measure is LVEF as measured by echocardiography at 6 months.
A composite of all-cause mortality and HF events
The secondary outcome measure a composite of all-cause mortality and HF events at 6 months.
Packer Composite Clinical Outcome Score
The secondary outcome measure is Packer Composite Clinical Outcome Score at 6 months.

Full Information

First Posted
September 24, 2020
Last Updated
August 31, 2023
Sponsor
Anthony Tang
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1. Study Identification

Unique Protocol Identification Number
NCT04582578
Brief Title
Resynchronization for Ambulatory Heart Failure Trial in Patients With Preserved LV Function
Official Title
Resynchronization for Ambulatory Heart Failure Trial in Patients With Preserved LV Function (RAFT-Preserved)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Difficulty recruiting
Study Start Date
November 3, 2021 (Actual)
Primary Completion Date
February 23, 2023 (Actual)
Study Completion Date
February 23, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Anthony Tang

4. Oversight

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

5. Study Description

Brief Summary
This trial will compare two management strategies for HF patients with preserved LV function in sinus rhythm and LBBB. The control group will be treated with practice guideline optimal medical therapy for HF. The experimental group will be treated with CRT in addition to optimal medical therapy for HF. In addition, the trial will further compare two methods of delivering CRT. One experimental group will receive BiV-CRT, while the second experimental group will receive CS-CRT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
LBBB, Medical Therapy, Sinus Rhythm, Preserved LV Function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a multi-centre randomized controlled trial with a prospective randomized open blinded endpoint trial (PROBE) design.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group will be treated with practice guideline optimal medical therapy for HF.
Arm Title
BiV-CRT
Arm Type
Experimental
Arm Description
The experimental group will be treated with CRT in addition to optimal medical therapy for HF. In addition, the trial will further compare two methods of delivering CRT. One experimental group will receive BiV-CRT, while the second experimental group will receive Conduction System(CS)-CRT.
Arm Title
CS-CRT
Arm Type
Experimental
Arm Description
The experimental group will be treated with CRT in addition to optimal medical therapy for HF. In addition, the trial will further compare two methods of delivering CRT. One experimental group will receive BiV-CRT, while the second experimental group will receive Conduction System(CS)-CRT.
Intervention Type
Device
Intervention Name(s)
CRT
Intervention Description
The experimental group will be treated with CRT in addition to optimal medical therapy for HF. In addition, the trial will further compare two methods of delivering CRT. One experimental group will receive BiV-CRT, while the second experimental group will receive CS-CRT
Primary Outcome Measure Information:
Title
NTproBNP measurement
Description
The co-primary outcome measure is NTproBNP as measured at 6 months.
Time Frame
6 Months
Title
6-minute walk distance
Description
The co-primary outcome measure is 6 minute hall walk distance as measured at 6 months.
Time Frame
6 Months
Title
Quality of Life (QoL) score
Description
The co-primary outcome measure is quality of life as measured using the Minnesota Living with Heart Failure Questionnaire (MLHFQ) score. The MLHFQ consists of 21 questions answered on a 0-5 likert scale, with higher scores indicating a stronger impact of heart failure on QoL.
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Ventricular arrhythmia burden determined by the device capture of arrhythmias and adjudication by a device review committee blinded to patient's treatment allocation
Description
The secondary outcome measure is Ventricular arrhythmia burden determined by the device as measured at 6 months.
Time Frame
6 Months
Title
LV reverse remodeling (LVESVi on echocardiography)
Description
The secondary outcome measure is LV reverse remodeling as measured by LVESVi on echocardiography at 6 months.
Time Frame
6 Months
Title
LVEF
Description
The secondary outcome measure is LVEF as measured by echocardiography at 6 months.
Time Frame
6 Months
Title
A composite of all-cause mortality and HF events
Description
The secondary outcome measure a composite of all-cause mortality and HF events at 6 months.
Time Frame
6 Months
Title
Packer Composite Clinical Outcome Score
Description
The secondary outcome measure is Packer Composite Clinical Outcome Score at 6 months.
Time Frame
6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with NYHA class II-IVa HF symptoms and are on diuretic therapy LVEF > 35% (stratify by LVEF 36-49% and LVEF ≥ 50%), and recovered LVEF (previously LVEF ≤ 35%, but improved to LVEF > 35% with medical therapy) Patients with LVEF ≥ 50% must also have either left atrial enlargement (any of the following: LA diameter ≥3.8 cm, LA length ≥5.0 cm, LA volume ≥55 ml, LA volume index (LAVi) ≥29 mL/m2) or LV hypertrophy (LV mass index (LVMI) ≥115 g/m2 for males and ≥ 95g/m2 for females) LBBB and QRS duration ≥ 140 msec. for men or ≥ 130 msec. for women, and with mid-QRS notching or slurring in ≥ 2 leads Patients may have permanent RV pacing with a QRS duration ≥180ms Patients may have permanent atrial fibrillation with good rate control defined as a resting heart rate of ≤80 bpm at rest and ≤110 bpm with 6-minute walk test NT-proBNP ≥ 600 pg/ml on stable medical therapy without previous heart failure hospitalization in the last 12 months, or ≥400 pg/ml on stable medical therapy if there was a heart failure hospitalization within the previous 12 months Appropriate pharmacological treatment of HF and co-morbidities. Stable diuretic and other HF medications for at least four weeks Exclusion Criteria: Serum creatinine >180 μmol/L; or estimated glomerular filtration rate [eGFR] ≤30 mL/min/1.73 m2, calculated using the Modification of Diet in Renal Disease formula In-hospital patients with acute cardiac or non-cardiac illness that requires intensive care Acute coronary syndrome (including MI) <4 weeks Coronary revascularization (CABG or PCI) < 3 months Uncorrected or uncorrectable primary valvular disease TAVI < 3 months Restrictive, or reversible form of cardiomyopathy, cardiac amyloidosis Severe primary pulmonary disease such as cor pulmonale, primary pulmonary hypertension (may include secondary pulmonary hypertension, if mean pulmonary pressure is ≤ 70 mm Hg) Expected to undergo cardiac transplantation within one year (status I) Patients with a life expectancy of less than one year from non-cardiac cause. Patients included in other clinical trials that will affect the objectives of this study Patients who are pregnant/intend to get pregnant Those unable or unwilling to provide informed consent
Facility Information:
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Resynchronization for Ambulatory Heart Failure Trial in Patients With Preserved LV Function

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