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Denervation of the renAl sympathetIc nerveS in hearT Failure With nOrmal Lv Ejection Fraction (DIASTOLE)

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ClinicalTrials.gov Identifier: NCT01583881
Recruitment Status : Unknown
Verified October 2015 by Michiel Voskuil, MD, PhD, UMC Utrecht.
Recruitment status was:  Active, not recruiting
First Posted : April 24, 2012
Last Update Posted : November 2, 2015
Sponsor:
Collaborator:
VU University of Amsterdam
Information provided by (Responsible Party):
Michiel Voskuil, MD, PhD, UMC Utrecht

Study Description
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Brief Summary:
Increasing evidence suggests an important role of activation of the sympathetic nervous system (SNS) in the clinical phenomena of heart failure with normal left ventricular ejection fraction and hypertension. The current study aims to evaluate efficacy and safety of renal sympathetic denervation for the modulation of the SNS in patients with heart failure with normal LV ejection fraction.

Condition or disease Intervention/treatment Phase
Diastolic Heart Failure Hypertension Procedure: renal denervation Phase 2 Phase 3

Detailed Description:

Rationale: Increasing evidence suggests an important role of activation of the sympathetic nervous system (SNS) in the clinical phenomena of heart failure with normal left ventricular ejection fraction and hypertension. Moreover, sympathetic activation of the kidneys is directly proportional related to the severity of the heart failure state. Therapeutic renal denervation (PRDN), the deliberate disruption of the nerves connecting the kidneys with the central nervous system, has been shown to be an effective means of modulating elevated SNS activity. The current study aims to evaluate efficacy and safety of renal sympathetic denervation for the modulation of the SNS in patients with heart failure with normal LV ejection fraction.

Objective: Primary objectives: To investigate the efficacy of PRDN by means of pulsed wave Doppler echocardiographic parameters in patients diagnosed with HFNEF and hypertension. Secondary objectives: to investigate the safety of PRDN in patients with heart failure with normal LV ejection fraction and hypertension and to compare changes in the following parameters in patients with HFNEF and hypertension after PRDN: LV mass, LV volume, LA volume, LVEF, MIBG-uptake and -washout, BNP levels, blood pressure, heart rate variability, exercise capacity and quality of life.

Study design: Multicentre, prospective, randomised controlled trial. 60 patients will be randomly allocated in a one-to-one ratio to undergo renal denervation with previous treatment (n=30) or to maintain previous treatment alone (n=30) at 2 participating centres. Randomisation will be done with sealed envelopes.

Study population: Patients diagnosed with heart failure with normal LV ejection fraction and treated for hypertension. Patients should have a stable drug regimen, with at least 2 antihypertensive agents. This drug regimen should be expected to be maintained for at least 6 months.

Endpoints: The efficacy of PRDN will be evaluated primarily using echocardiographic parameters. Also, safety of PRDN on major and minor adverse events, LV mass, LV and LA dimensions, MIBG uptake and clinical endpoints will be evaluated.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sympathetic Renal Denervation in Heart Failure With Normal LV Ejection Fraction: Denervation of the renAl sympathetIc nerveS in hearT Failure With nOrmal Lv Ejection Fraction
Study Start Date : April 2012
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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Arm Intervention/treatment
Experimental: Renal denervation
Renal denervation
 Procedure: renal denervation
Renal denervation
No Intervention: control
No intervention


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline E/E' at 12 months [ Time Frame: 12 months after treatment ]
    Echocardiography will be used to measure the E/E'


Secondary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Individual is diagnosed with heart failure with a normal LV ejection fraction. The diagnosis of HFNEF requires the following conditions to be satisfied:

    • signs or symptoms of heart failure;
    • normal or mildly abnormal systolic LV function (LVEF ≥ 50%);
    • evidence of diastolic LV dysfunction.
  • Individual should fulfill the diagnostic WHO criteria for hypertension: SBP > 140 mmHg and/or DBP > 90 mmHg, and is treated with at least 2 antihypertensive drugs. This treatment is expected to be maintained for at least 6 months. Using this regimen the blood pressure should be adequately controlled (< 140/90mmHg by 24 hour ambulatory BP measurement).
  • Individual is adhering to a stable drug regimen HFNEF, with no changes for a minimum of 2 weeks prior to enrollment, and which is expected to be maintained for at least 6 months.
  • Individual is ≥ 18 years of age.

Exclusion Criteria:

  • Known secondary cause of hypertension
  • Anatomy not eligible for renal denervation
  • Systolic heart failure (LVEF < 50%)
  • Individual has an estimated glomerular filtration rate (eGFR) of < 30mL/min/1.73m2, using the MDRD calculation.
  • Individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, haemophilia, significant anaemia, or arrhythmias such as atrial fibrillation).
  • Individual is pregnant, nursing or planning to be pregnant.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01583881


Locations
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Netherlands
VUmc
Amsterdam, Netherlands
UMC Utrecht
Utrecht, Netherlands
Sponsors and Collaborators
UMC Utrecht
VU University of Amsterdam
Investigators
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Principal Investigator: Michiel Voskuil, MD, PhD UMC Utrecht
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Michiel Voskuil, MD, PhD, MD. PhD., UMC Utrecht
ClinicalTrials.gov Identifier: NCT01583881     History of Changes
Other Study ID Numbers: 12-046
First Posted: April 24, 2012    Key Record Dates
Last Update Posted: November 2, 2015
Last Verified: October 2015

Keywords provided by Michiel Voskuil, MD, PhD, UMC Utrecht:
Patients with diastolic heart failure and hypertension

Additional relevant MeSH terms:
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Hypertension
Heart Failure
Heart Failure, Diastolic
 Vascular Diseases
Cardiovascular Diseases
Heart Diseases