Heart FailureNCT04582578
Resynchronization for Ambulatory Heart Failure Trial in Patients With Preserved LV Function
A study testing CRT in people with Heart Failure, run by Anthony Tang at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- CRT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 3 Nov 2021to 23 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Resynchronization for Ambulatory Heart Failure Trial in Patients With Preserved LV Function (RAFT-Preserved)
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.
- Conditions
- Heart Failure
- Being tested
- CRT
- Keywords
- LBBB, Medical Therapy, Sinus Rhythm, Preserved LV Function
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRTDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | The control group will be treated with practice guideline optimal medical therapy for HF. |
| BiV-CRT | Experimental | 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. Receives: Device: CRT |
| CS-CRT | Experimental | 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. Receives: Device: CRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
NTproBNP measurement
The co-primary outcome measure is NTproBNP as measured at 6 months.
Measured: 6 Months
6-minute walk distance
The co-primary outcome measure is 6 minute hall walk distance as measured at 6 months.
Measured: 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.
Measured: 6 Months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 6 Months
LVEF
The secondary outcome measure is LVEF as measured by echocardiography at 6 months.
Measured: 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.
Measured: 6 Months
Packer Composite Clinical Outcome Score
The secondary outcome measure is Packer Composite Clinical Outcome Score at 6 months. The Packer Clinical Composite Score classifies each patient into 1 of 3 categories (improved, worsened, unchanged), and is determined using clinical outcomes, heart failure status, and patient symptoms. Patients are considered improved if at the final visit they experienced in the patient assessment of a pre-specified scale but did not experience any major adverse clinical events throughout the trial. If considered worse, patients experienced a major clinical event during the planned duration of double-blind treatment or reported worsening at their final visit. And if considered unchanged, patients would be considered neither improved nor worse.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start3 Nov 2021
- Primary completion23 Feb 2023
- Study completion23 Feb 2023
Why it stopped: Difficulty recruiting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multi-centre randomized controlled trial with a prospective randomized open blinded endpoint trial (PROBE) design.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anthony Tang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anthony Tang, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04582578
- Sponsor's protocol ID
- CTO 3310
- Status last verified
- Nov 2023
- First submitted
- 24 Sep 2020
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resynchronization for Ambulatory Heart Failure Trial in Patients With Preserved LV Function (RAFT-Preserved)
- ClinicalTrials.gov ID
- NCT04582578
- Acronym / sponsor ID
- CTO 3310
- Conditions
- Heart Failure
- Keywords
- LBBB, Medical Therapy, Sinus Rhythm, Preserved LV Function
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulty recruiting
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Anthony TangUniversity, hospital or other
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- 23 Feb 2023 (actual)
- Study completion
- 23 Feb 2023 (actual)
- First posted
- 9 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a multi-centre randomized controlled trial with a prospective randomized open blinded endpoint trial (PROBE) design.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –The control group will be treated with practice guideline optimal medical therapy for HF. |
| BiV-CRT | Experimental | Device: CRTThe 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. |
| CS-CRT | Experimental | Device: CRTThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRTThe 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 | Device | BiV-CRT, CS-CRT |
Primary outcome
NTproBNP measurement
Time frame: 6 Months
The co-primary outcome measure is NTproBNP as measured at 6 months.
6-minute walk distance
Time frame: 6 Months
The co-primary outcome measure is 6 minute hall walk distance as measured at 6 months.
Quality of Life (QoL) score
Time frame: 6 Months
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.
5 secondary outcomes
Ventricular arrhythmia burden determined by the device capture of arrhythmias and adjudication by a device review committee blinded to patient's treatment allocation
Time frame: 6 Months
LV reverse remodeling (LVESVi on echocardiography)
Time frame: 6 Months
LVEF
Time frame: 6 Months
A composite of all-cause mortality and HF events
Time frame: 6 Months
Packer Composite Clinical Outcome Score
Time frame: 6 Months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRT in people with Heart Failure, run by Anthony Tang at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NTproBNP measurement (time frame: 6 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.