Renal Denervation in Hypertrophic Cardiomyopathy

NCT05577208 | Unknown DMC FDA Device

• 1 other identifier: SNYPER-PS
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Hypertrophic cardiomyopathy (HCM) is the most common inherited monogenic heart disease. There is an abnormal increase in myocardial mass in this disorder that leads to a state of cardiac sympathetic hypertonia, which is involved in disease progression, development of arrhythmias and heart failure. Cardiac sympathetic hyperactivity may constitute a new therapeutic target in HCM patients who persist symptomatic despite conventional treatment. The hypothesis of this project is that renal denervation (a minimally invasive percutaneous interventional therapy with proven efficacy in resistant arterial hypertension) reduces cardiac sympathetic activity in HCM. The SNYPER pilot study is a non-randomized clinical trial with medical devices (proof of concept), in which a renal denervation procedure will be performed in 20 patients with genetically confirmed sarcomeric HCM, severe left ventricular hypertrophy and persistent symptoms. The impact of denervation in reducing the 123I-meta iodo benzyl guanidine (MIBG) washout rate quantified by isotopic tracing (planar imaging and SPECT) at 6 months is established as a primary efficacy objective, and the proportion of renal denervation-related complications as a safety objective. The most relevant secondary endpoints are the outcomes of renal denervation on left ventricular mass (echocardiogram), diastolic function, maximum oxygen consumption (ergospirometer), ventricular arrhythmia burden (Holter), blood pressure (ABPM), N-terminal (NT) Pro Brain Natriuretic Peptide (BNP) and quality of life (KCCQ questionnaire). The results of this study may open the development of a new, technically simple and easily accessible therapeutic line for the treatment of HCM.

Conditions

Hypertrophic Cardiomyopathy

Keywords

renal denervation

Outcome Measures

Primary Outcomes (1)

• Cardiac sympathetic nerve activity (123I-MIBG washout rate)

  123I-MIBG washout rate measured by scintigraphy

  6 months

Secondary Outcomes (10)

• Functional status

  6 months

• Left ventricular mass

  6 months

• Diastolic function

  6 months

• Subaortic gradient (left ventricular outflow tract obstruction [LVOT])

  6 months

• Number of ventricular tachycardia episodes

  6 months

Study Arms (1)

renal denervation

EXPERIMENTAL

Renal denervation shall be performed by echo-guided catheterization of the femoral artery, and subsequent cannulation of the renal arteries with a guide catheter. A renal denervation catheter shall be advanced through the guide catheter to the distal portion of the artery. The procedures shall be aimed to deliver as many radiofrequency applications as possible, 0.5 cm apart, intended duration of 60 sec, to all four quadrants of the renal arteries and main branch vessels with \> 3 mm diameter.

Device: "Symplicity Spyral" multi-electrode renal denervation catheter and "Symplicity G3" generator (Renal Denervation System)

Interventions

"Symplicity Spyral" multi-electrode renal denervation catheter and "Symplicity G3" generator (Renal Denervation System) DEVICE

Minimally invasive percutaneous interventional therapy aimed to modulate the sympathetic nervous system through endovascular ablation of both renal arteries

renal denervation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sarcomeric HCM (absence of metabolic, syndromic or neurological diseases with increased left ventricular thickness) confirmed by genetic study (pathogenic or probably pathogenic variant identified in a sarcomeric gene).
• NYHA Class II-IV despite optimal therapy for the last 30 days.
• Left ventricular septum \> 16 mm.
• Age between 18 and 80 years.
• Not candidate to septal reduction therapy or valve surgery.

You may not qualify if:

• Non sarcomeric causes of increased left ventricular thickness.
• Left ventricular systolic disfunction (EF \< 50%) or dilatation (indexed left ventricular end diastolic volume \[LVEDV\] \> 75 ml/m2 for men and \> 62 ml/m2 for women).
• Blood pressure \< 100/50 mmHg.
• Severe functional impairment due to concomitant diseases.
• Renal glomerular filtration \< 30 ml/min/m2 (Cockcroft-Gault´s formula).
• Hospitalization for heart failure, stroke or acute coronary syndrome (ACS) in the last 30 days.
• Heart failure requiring inotropic drugs or intravenous diuretics over the last 30 days, or in the waiting list for heart transplantation.
• Unfavorable renal artery anatomy (significant stenosis, diameter \< 2mm, length \< 4mm)
• Women on pregnancy, lactation or fertile age without contraception.
• Parkinson´s disease or Lewy body dementia.
• Life expectancy less than one year
• Unwilling to sign informed consent or to undergo study procedure and visits.
• Participation in other clinical trial over the last 30 days.

Sponsors & Collaborators

• Adolfo Fontenla: lead

Study Sites (1)

Hospital Universitario 12 de Octubre

Madrid, 28015, Spain

RECRUITING

Related Publications (23)

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MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Officials

• Adolfo Fontenla, MD, PhD

  Hospital Universitario 12 de Octubre

  STUDY CHAIR

• Adolfo Fontenla, MD, PhD

  Hospital Universitario 12 de Octubre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adolfo Fontenla, MD, PhD

CONTACT

+34699012607; adolforamon.fontela@saludmadrid.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 6, 2022
• First Posted: October 13, 2022
• Study Start: November 26, 2022
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: November 29, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: not defined
• Access Criteria: not defined

Locations

ES (1)