Adjunctive Renal Sympathetic Denervation to Modify Hypertension as Upstream Therapy in the Treatment of Atrial Fibrillation (H-FIB)

This study has suspended participant recruitment.
(Per DSMB, enrollment halted pending further review of safety data)
Sponsor:
Information provided by (Responsible Party):
Vivek Reddy, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01635998
First received: July 5, 2012
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Uncontrolled Hypertension
Atrial Fibrillation
Device: Renal sympathetic denervation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adjunctive Renal Sympathetic Denervation to Modify Hypertension as Upstream Therapy in the Treatment of Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Anti-arrhythmic drug (AAD)-free single-procedure freedom from atrial fibrillation recurrence [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • AAD-free single-procedure freedom from AF recurrence through 24 months [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
    AAD-free single-procedure freedom from AF recurrence through 24 months (not-including recurrences within the first 90 days of the initial ablation procedure)

  • Freedom from AF recurrence through 24 months (not-including the pre-defined 90 day blanking period) despite taking AADs [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
    Freedom from AF recurrence through 24 months (not-including the pre-defined 90 day blanking period) despite taking AADs

  • Blood pressure control as compared to baseline [ Time Frame: baseline, 6 months, 12 months, and 24 months ] [ Designated as safety issue: No ]
    Blood pressure control between the two groups as compared to baseline at 6 months, 12 months and 24 months.

  • plasma norepinephrine and BNP measurements [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
    Differences in plasma norepinephrine and BNP measurements

  • plasma norepinephrine and BNP measurements [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
    Differences in plasma norepinephrine and BNP measurements

  • Major adverse cardiac events (MACE) [ Time Frame: up to 24 months ] [ Designated as safety issue: Yes ]
    defined as a non-weighted composite score of: death, stroke, CHF hospitalization, clinically diagnosed thromboembolic events other than stroke and hemorrhage requiring transfusion within 12 months of randomization

  • Serious Adverse Events (SAE) [ Time Frame: up to 24 months ] [ Designated as safety issue: Yes ]
    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

  • change in measures of LV hypertrophy and LA size [ Time Frame: at baseline and at 12 months ] [ Designated as safety issue: No ]
    Differences in measures of LV hypertrophy (LV wall thickness, mitral inflow parameters) and LA size by TTE at baseline and at 12 months for each patient

  • Procedure adverse events [ Time Frame: up to 24 months ] [ Designated as safety issue: Yes ]
    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).

  • anti-hypertensive medications [ Time Frame: at 24 months ] [ Designated as safety issue: No ]
    Total number of anti-hypertensive medications at study end, compared between the two treatment arms

  • change in Quality of Life [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
    The change in QoL from baseline to 12 months will be measured using two quality of life instruments (AFEQT and SF-12).


Estimated Enrollment: 300
Study Start Date: September 2012
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ablation arm
These subjects will undergo catheter ablation of atrial fibrillation plus renal sympathetic denervation.
Device: Renal sympathetic 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.
Other Names:
  • renal denervation
  • denervation
No Intervention: control arm
These subjects will undergo catheter ablation of atrial fibrillation only.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inclusion Criteria
  • 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.
  • 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

Exclusion Criteria

  • 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:

    1. Inability to access renal vasculature
    2. Main renal arteries < 4 mm in diameter or < 20 mm in length.
    3. 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.
    4. A history of prior renal artery intervention including balloon angioplasty or stenting that precludes a possibility of ablation treatment.
    5. Multiple main renal arteries to either kidney
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01635998

Locations
United States, Alabama
University of Alabama - Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Regional Cardiology Associates
Sacramento, California, United States, 95819
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
HeartPlace Baylor
Dallas, Texas, United States, 75204
Germany
University of Leipzig - Heart Center
Leipzig, Germany
Sponsors and Collaborators
Vivek Reddy
Investigators
Principal Investigator: Vivek Reddy, MD Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Vivek Reddy, Director Cardiac Arrhythmia Service, Professor of Medicine, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01635998     History of Changes
Other Study ID Numbers: GCO 12-1465, GCO 12-0662
Study First Received: July 5, 2012
Last Updated: August 11, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
renal sympathetic denervation
renal catheter ablation
hypertension

Additional relevant MeSH terms:
Hypertension
Atrial Fibrillation
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 29, 2014