Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007368

Trial Description

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Title

A Prospective, Multicenter, Randomized, Open-label, Feasibility, Safety and Efficacy Study of Renal Denervation in Patients With Chronic Heart Failure (CHF)

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The purpose of the trial is to investigate the safety and effectiveness of renal denervation
for the treatment of chronic heart failure (CHF).

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Brief Summary in Scientific Language

Heart failure is a major public health problem. It is associated with high mortality,
frequent hospitalization and represents a large cost to the health care system. Therapies
to ameliorate the high mortality and morbidity of heart failure have focused on abrogation
of activated neurohormonal systems associated with this condition. These systems include
the renin-angiotensin-aldosterone system and the sympathetic nervous system.

Strategies to ameliorate sympathetic activation have primarily focused on blockade of the
beta-adrenoceptors that mediate the adverse effects of activation of this system upon the
myocardium. This has been a highly successful strategy with beta-blockers resulting in an
approximately 35% reduction in mortality as well as improvements in hospitalization and
quality of life and attenuation of disease progression.

However, less than full blockade of the effects of the sympathetic nervous system is
achieved with the use of conventional doses of beta-blockers. Moreover, a not insignificant
fraction of patients are unable to tolerate beta-blockers or are not able to have them
up-titrated to target effective doses, in large part because of the systemic nature of these
agents, whereas renal denervation allows the selective removal of the kidney's contribution
to central sympathetic drive without blunting other compensatory mechanisms.

The renin-angiotensin-aldosterone axis has also been found to be a key system involved in
heart failure disease progression and it too may be inhibited by renal sympathetic
denervation.

Therefore, a clear need exists for further strategies to beneficially manipulate the
sympathetic activation that is characteristic of the heart failure disease process.

Cardiorenal syndrome is a major comorbid condition of patients with advanced chronic heart
failure. In the setting of renal hypoperfusion and/or activation of neurohormonal and
cytokine systems there is a reduction in glomerulofiltration. Renal function has been found
to be a major determine of prognosis in these patients. Strategies to ameliorate
cardiorenal syndrome are being actively pursued. There is considerable a priori evidence to
suggest that the sympathetic nervous system, in particular renal sympathetic, is a key
factor to the progression of cardiorenal syndrome and impaired tubulo-glomerular feedback.
In particular renal sympathetics reduce renal perfusion through vascular alpha adrenergic
receptor stimulation as well as, indirectly, through stimulation of local release of
adenosine causing afferent glomerular arteriole constriction. We hypothesize that by
disrupting renal sympathetic afferent and efferent activity these salutary adenosine
inhibitory mediated effects will be demonstrated using the renal denervation approach.

A number of studies with hypertension patients indicate that the Symplicity Catheter System
can safely denervate the kidney without significant periprocedural complications.

In a small first-in man pilot study, involving seven normotensive patients with chronic
heart failure, six months after renal denervation their 6-min walk distance improved
significantly and the patients' self-assessment of well-being also improved. No procedural
or post procedural complications following renal denervation in patients in 6 months of
intensive follow-up were found.

The investigators believe that therapeutic renal denervation using the Symplicity Catheter
is a promising therapy for patients with elevated sympathetic activity, as in CHF.

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Organizational Data

  •   DRKS00007368
  •   2016/03/22
  •   2014/03/10
  •   yes
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Secondary IDs

  •   NCT02085668  (ClinicalTrials.gov)
  •   CIV-13-10-011660 
  •   RE-ADAPT-HF  (University Hospital, Saarland)
  •   CIV-13-10-011660 
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Health Condition or Problem studied

  •   Chronic Heart Failure
  •   Cardio-Renal Syndrome
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Interventions/Observational Groups

  •   Device: Renal denervation (Symplicity™)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Treatment
  •   Parallel
  •   N/A
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Primary Outcome

- Safety of renal denervation with the Symplicity Catheter System with special consideration of clinically significant periprocedural adverse events in CHF patients; time frame: Baseline visit for treatment group, month 6 visit for control group; Number of complications associated with the delivery and/or use of the Symplicity Catheter (e.g., vascular injury and bleeding complications, access site hematoma, etc.).
Vital signs, blood and urine measurements taken before, during and after the denervation procedure

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Secondary Outcome

- Physiologic response to renal denervation: ventricular function; time frame: From denervation prodecure to 6 months after renal denervation procedure; Measured by echocardiography at 6 months
- Physiologic Response to renal denervation: renal function; time frame: From denervation prodecure to 6 months after renal denervation procedure; Calculated by glomerular filtration rate (GFR) at 6 months
- Physiologic Response to renal denervation: symptomatology/Quality of Life; time frame: From denervation prodecure to 6 months after renal denervation procedure; Measured by EuroQol - 5 dimensions (EQ-5D) and by Kansas City Cardiomyopathy questionnaires at 6 months after renal denervation
- Physiologic Response to renal denervation: additional parameters; time frame: From denervation prodecure to 6 months after renal denervation procedure; Composite measure

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Countries of Recruitment

  •   Austria
  •   Germany
  •   Sweden
  •   Switzerland
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Locations of Recruitment

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Recruitment

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  •   2014/05/31
  •   100
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

- New York Heart Association Class II-III symptoms of chronic heart failure

- Systolic left ventricular dysfunction as assessed by echocardiogram with left
ventricular ejection fraction in a range of 10%- 40%.

- GFR >30 mL/min/1.73m2

- Brain natriuretic Peptide (BNP) >100 pg/ml or N terminal (NT)-Pro-BNP >400 pg/ml.

- Optimal medical therapy according to current guidelines for CHF management. Treatment
for HF must be stable (including drug and dose) for at least 4 weeks prior to
procedure, with the exception of diuretics, where stability is required for at least
2 weeks.

- others

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Exclusion Criteria

- Renal arterial anatomy that is ineligible for treatment

- CHF caused by pericarditis or by acute myocarditis or by endocrine diseases.

- Myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within
three 12 weeks of the screening visit.

- Office systolic BP at screening less than 90 mmHg

- Primary pulmonary hypertension.

- Clinically significant cardiac structural valvular disease, unless corrected by a
properly functional prosthetic valve

- Major surgery, including bariatric surgery, in the previous 12 weeks before baseline.

- Contrast media administration in the previous 30 days before baseline.

- Known hypersensitivity to material of the Symplicity Catheter.

- Inpatient hospitalization for decompensated HF in the previous 60 days before
baseline.

- others

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Addresses

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    • University Hospital, Saarland
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    • University Hospital, Saarland
    • Michael Böhm, MD 
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    • Felix Mahfoud, MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2015/06/17
* This entry means the parameter is not applicable or has not been set.