Uncontrolled HypertensionH-FIBNCT01635998
Adjunctive Renal Denervation in the Treatment of Atrial Fibrillation
A study testing Boston Scientific Vessix Renal Denervation System in people with Uncontrolled Hypertension and Atrial Fibrillation, run by Vivek Reddy at 8 sites in 3 countries.
Trial summary
The objective of the H-FIB trial is to determine the role of renal sympathetic denervation in the prevention of Atrial Fibrillation (AF) recurrence in patients with hypertension for whom a catheter-based AF ablation procedure is planned. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Uncontrolled Hypertension, Atrial Fibrillation
- What is being tested?
- Boston Scientific Vessix Renal Denervation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 17 Sep 2012to 11 Jul 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years of age
- History of AF (paroxysmal or persistent) and planned for a guideline-supported catheter ablation procedure
- History of significant hypertension (defined as SBP ≥160 mm Hg and/or DBP ≥100 mmHg) and receiving treatment with at least one anti-hypertensive medication OR Clinical History of hypertension and receiving treatment with at least two anti-hypertensive medications (specifically for blood pressure reduction).
- Renal vasculature is accessible as determined by intra-procedural renal angiography.
- Ability to understand the requirements of the study
- Willingness to adhere to study restrictions, comply with all post-procedural follow-up requirements and to sign informed consent
Who cannot join
- Inability to undergo AF catheter ablation (e.g., presence of a left atrial thrombus, contraindication to all anticoagulation)
- Prior left atrial ablation for an atrial arrhythmia (before this index procedure)
- Patients with NYHA class IV congestive heart failure
- Individual has known secondary hypertension
- Individual has renal artery anatomy that is ineligible for treatment including:
- Inability to access renal vasculature
Show all 13Show fewer
- Main renal arteries < 3 mm in diameter or < 20 mm in length.
- Hemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery which, in the eyes of the operator, would interfere with safe cannulation of the renal artery or meets standards for surgical repair or interventional dilation.
- A history of prior renal artery intervention including balloon angioplasty or stenting that precludes a possibility of ablation treatment.
- Individual has an estimated glomerular filtration rate (eGFR) of less than 45mL/min/1.73m2, using the MDRD calculation.
- Individual has a single functioning kidney (either congenitally or iatrogenically).
- Individual is pregnant or nursing.
- Life expectancy <1 year for any medical condition
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
United States6 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02215
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Kansas Medical Center
Kansas City, Kansas, 66160
Mount Sinai Hospital
New York, New York, 10029
Regional Cardiology Associates
Sacramento, California, 95819
Russia1 site
Siberian Biomedical Research Center Ministry of Health Russian Federation
Novosibirsk, 630055
About this study
Official title: Adjunctive Renal Denervation to Modify Hypertension and Sympathetic Tone as Upstream Therapy in the Treatment of Atrial Fibrillation
The objective of the H-FIB trial is to determine the role of renal sympathetic denervation in the prevention of Atrial Fibrillation (AF) recurrence in patients with hypertension for whom a catheter-based AF ablation procedure is planned. Patients will be randomized to either AF catheter ablation (usual therapy) or AF catheter ablation plus renal sympathetic denervation.
Read the detailed description
The purpose of this study is to examine the potential additional benefit of performing renal sympathetic denervation at the same time as an AF ablation procedure, in order to improve the long-term success of the AF procedure.
To take part in this study, you must meet all study requirements. Screening visit tests and procedures such as a physical exam, blood pressure, review of medical history, blood sample, and a Transthoracic Echocardiogram (TTE) are done to see if you are eligible to be in the study.
Patients who qualify for the study and provide consent will undergo catheter ablation for AF. Very thin electrode catheters, similar to long wires, will be inserted into blood vessels in the groin. Using the ablation catheter, we will "ablate" or damage the tissue adjacent to your pulmonary veins that is not behaving normally.
Immediately following the catheter ablation, patients will undergo a renal angiogram in order to assess suitability for catheter-based renal sympathetic denervation. A renal angiogram is an x-ray study of the blood vessels in the kidney to evaluate for blockage, and abnormalities that could be affecting the blood supply to the kidney. It is performed by injecting contrast dye through a catheter (a tiny tube) into the blood vessels of the kidney.
- Conditions
- Uncontrolled Hypertension, Atrial Fibrillation
- Being tested
- Boston Scientific Vessix Renal Denervation System
- Keywords
- renal sympathetic denervation, renal catheter ablation, hypertension
- Medical subject headings
- Atrial Fibrillation, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boston Scientific Vessix Renal Denervation SystemDevice
Also called renal denervation, denervation
Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation.
Boston Scientific Vessix Renal Denervation System, Boston Scientific, Inc., Quincy, Massachusetts
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | These subjects will undergo routine catheter ablation of atrial fibrillation PLUS renal sympathetic denervation with the Boston Scientific Vessix Renal Denervation System. Receives: Device: Boston Scientific Vessix Renal Denervation System |
| Control arm | No intervention | These subjects will undergo routine catheter ablation of atrial fibrillation only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-arrhythmic Drug (AAD)-Free Single-procedure Freedom From Atrial Fibrillation Recurrence
The primary endpoint of this study is anti-arrhythmic drug (AAD)-free single-procedure freedom from AF recurrence through 12 months (not including a 90 day blanking period).
Measured: up to 12 months
Secondary outcomes (10)
AAD-free Single-procedure Freedom From AF Recurrence
AAD-free single-procedure freedom from AF recurrence through 24 months (not-including recurrences within the first 90 days of the initial ablation procedure)
Measured: up to 24 months
Freedom From AF Recurrence Despite Taking AADs
Freedom from AF recurrence through 24 months (not-including the pre-defined 90 day blanking period) despite taking AADs
Measured: up to 24 months
Blood Pressure Control as Compared to Baseline
Blood pressure control between the two groups as compared to baseline at 6 months, 12 months and 24 months.
Measured: baseline, 6 months, 12 months, and 24 months
Number of Participants With Major Adverse Cardiac Events (MACE)
Number of Participants with Major adverse cardiac events (MACE) defined as a non-weighted composite score of: death, stroke, CHF hospitalization, and clinically diagnosed thromboembolic events other than stroke and hemorrhage requiring transfusion within 12 months of randomization
Measured: within 12 months of randomization
Number of Participants With Serious Adverse Events (SAE)
SAE-any experience that results in a fatality or is life threatening; results in significant or persistent disability; requires or prolongs hospitalization; results in congenital anomaly/birth defect; or represents other significant hazards or potentially serious harm to research subjects or others, in the opinion of the investigators. Important medical events that may not result in above may be considered a SAE when, based upon appropriate medical judgment, they may jeopardize the patient and may require medical or surgical intervention to prevent one of the outcomes listed in this definition
Measured: up to 24 months
Left Atrial (LA) Size
LA size by TTE at baseline and at 12 months
Measured: at baseline and at 12 months
Ejection Fraction (EF)
Ejection fraction (EF) is a measurement, expressed as a percentage, of how much blood the left ventricle pumps out with each contraction. A normal heart's ejection fraction may be between 50 and 70 percent.
Measured: at baseline and at 12 months
Number of Participants With Procedure Adverse Events
Causality will be defined as adverse events that, after careful medical evaluation, are considered with a high degree of certainty to be related to the intervention (AF ablation ± renal sympathetic denervation).
Measured: up to 24 months
Number of Anti-hypertensive Medications
Total number of anti-hypertensive medications at study end, compared between the two treatment arms
Measured: baseline and 24 months
Atrial Fibrillation Effect on QualiTy-of-life Questionnaire (AFEQT)
The change in quality of life (QoL) from baseline to 12 months as measured by AFEQT, a 20- item instrument. Full range from 0 to 100, with higher score indicates higher level of QoL.
Measured: baseline, 12 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2012 (estimated)
- Study start17 Sep 2012
- Primary completion11 Jul 2019
- Study completion11 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Uncontrolled HypertensionStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vivek Reddy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Vivek Reddy, Icahn School of Medicine at Mount Sinai
- Investigators
- Vivek Reddy, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01635998
- Sponsor's protocol ID
- GCO 12-1465
- Other IDs
- GCO 12-1465
- Acronym
- H-FIB
- Status last verified
- Oct 2020
- First submitted
- 5 Jul 2012
- Last updated
- 5 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Renal Denervation to Modify Hypertension and Sympathetic Tone as Upstream Therapy in the Treatment of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT01635998
- Acronym / sponsor ID
- H-FIB / GCO 12-1465
- Conditions
- Uncontrolled Hypertension, Atrial Fibrillation
- Keywords
- renal sympathetic denervation, renal catheter ablation, hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Vivek ReddyUniversity, hospital or other
- Study start
- 17 Sep 2012 (actual)
- Primary completion
- 11 Jul 2019 (actual)
- Study completion
- 11 Jul 2019 (actual)
- First posted
- 10 Jul 2012 (estimated)
- Results
- Posted 5 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the H-FIB trial is to determine the role of renal sympathetic denervation in the prevention of Atrial Fibrillation (AF) recurrence in patients with hypertension for whom a catheter-based AF ablation procedure is planned. Patients will be randomized to either AF catheter ablation (usual therapy) or AF catheter ablation plus renal sympathetic denervation.
Detailed description
The purpose of this study is to examine the potential additional benefit of performing renal sympathetic denervation at the same time as an AF ablation procedure, in order to improve the long-term success of the AF procedure.
To take part in this study, you must meet all study requirements. Screening visit tests and procedures such as a physical exam, blood pressure, review of medical history, blood sample, and a Transthoracic Echocardiogram (TTE) are done to see if you are eligible to be in the study.
Patients who qualify for the study and provide consent will undergo catheter ablation for AF. Very thin electrode catheters, similar to long wires, will be inserted into blood vessels in the groin. Using the ablation catheter, we will "ablate" or damage the tissue adjacent to your pulmonary veins that is not behaving normally.
Immediately following the catheter ablation, patients will undergo a renal angiogram in order to assess suitability for catheter-based renal sympathetic denervation. A renal angiogram is an x-ray study of the blood vessels in the kidney to evaluate for blockage, and abnormalities that could be affecting the blood supply to the kidney. It is performed by injecting contrast dye through a catheter (a tiny tube) into the blood vessels of the kidney.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Device: Boston Scientific Vessix Renal Denervation SystemThese subjects will undergo routine catheter ablation of atrial fibrillation PLUS renal sympathetic denervation with the Boston Scientific Vessix Renal Denervation System. |
| Control arm | No intervention | –These subjects will undergo routine catheter ablation of atrial fibrillation only. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years of age
- History of AF (paroxysmal or persistent) and planned for a guideline-supported catheter ablation procedure
- History of significant hypertension (defined as SBP ≥160 mm Hg and/or DBP ≥100 mmHg) and receiving treatment with at least one anti-hypertensive medication OR Clinical History of hypertension and receiving treatment with at least two anti-hypertensive medications (specifically for blood pressure reduction).
- Renal vasculature is accessible as determined by intra-procedural renal angiography.
- Ability to understand the requirements of the study
Key exclusion criteria (13 listed)
- Inability to undergo AF catheter ablation (e.g., presence of a left atrial thrombus, contraindication to all anticoagulation)
- Prior left atrial ablation for an atrial arrhythmia (before this index procedure)
- Patients with NYHA class IV congestive heart failure
- Individual has known secondary hypertension
- Individual has renal artery anatomy that is ineligible for treatment including:
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 |
|---|---|---|
| Boston Scientific Vessix Renal Denervation SystemAlso: renal denervation, denervationRenal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation. Boston Scientific Vessix Renal Denervation System, Boston Scientific, Inc., Quincy, Massachusetts | Device | Intervention arm |
Primary outcome
Anti-arrhythmic Drug (AAD)-Free Single-procedure Freedom From Atrial Fibrillation Recurrence
Time frame: up to 12 months
The primary endpoint of this study is anti-arrhythmic drug (AAD)-free single-procedure freedom from AF recurrence through 12 months (not including a 90 day blanking period).
10 secondary outcomes
AAD-free Single-procedure Freedom From AF Recurrence
Time frame: up to 24 months
Freedom From AF Recurrence Despite Taking AADs
Time frame: up to 24 months
Blood Pressure Control as Compared to Baseline
Time frame: baseline, 6 months, 12 months, and 24 months
Number of Participants With Major Adverse Cardiac Events (MACE)
Time frame: within 12 months of randomization
Number of Participants With Serious Adverse Events (SAE)
Time frame: up to 24 months
Left Atrial (LA) Size
Time frame: at baseline and at 12 months
Ejection Fraction (EF)
Time frame: at baseline and at 12 months
Number of Participants With Procedure Adverse Events
Time frame: up to 24 months
Number of Anti-hypertensive Medications
Time frame: baseline and 24 months
Atrial Fibrillation Effect on QualiTy-of-life Questionnaire (AFEQT)
Time frame: baseline, 12 months and 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Vivek Reddy, MD principal investigator
Icahn School of Medicine at Mount Sinai
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Boston Scientific Vessix Renal Denervation System in people with Uncontrolled Hypertension and Atrial Fibrillation, run by Vivek Reddy at 8 sites in 3 countries.
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 6 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: finished, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Czechia, Russia. 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?
Yes. Results are posted in the registry (first posted 5 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Anti-arrhythmic Drug (AAD)-Free Single-procedure Freedom From Atrial Fibrillation Recurrence (time frame: up to 12 months). 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 5 Nov 2020.