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 1, 2015
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Condition or disease | Intervention/treatment | Phase |
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Diastolic Heart Failure Hypertension | Procedure: renal denervation | Phase 2 Phase 3 |
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 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 |

Arm | Intervention/treatment |
---|---|
Experimental: Renal denervation
Renal denervation
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Procedure: renal denervation
Renal denervation |
No Intervention: control
No intervention
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- Change from baseline E/E' at 12 months [ Time Frame: 12 months after treatment ]Echocardiography will be used to measure the E/E'
- Number of participants with adverse events [ Time Frame: 1 year ]

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

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
Netherlands | |
VUmc | |
Amsterdam, Netherlands | |
UMC Utrecht | |
Utrecht, Netherlands |
Principal Investigator: | Michiel Voskuil, MD, PhD | UMC Utrecht |
Responsible Party: | Michiel Voskuil, MD, PhD, MD. PhD., UMC Utrecht |
ClinicalTrials.gov Identifier: | NCT01583881 |
Other Study ID Numbers: |
12-046 |
First Posted: | April 24, 2012 Key Record Dates |
Last Update Posted: | November 1, 2015 |
Last Verified: | October 2015 |
Patients with diastolic heart failure and hypertension |
Hypertension Heart Failure Heart Failure, Diastolic |
Vascular Diseases Cardiovascular Diseases Heart Diseases |