Hypertrophic CardiomyopathySNYPER-PSNCT05577208
Renal Denervation in Hypertrophic Cardiomyopathy
A study testing "Symplicity Spyral" multi-electrode renal denervation catheter and "Symplicity G3" generator (Renal Denervation System) in people with Hypertrophic Cardiomyopathy, run by Adolfo Fontenla at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertrophic Cardiomyopathy
- What is being tested?
- "Symplicity Spyral" multi-electrode renal denervation catheter and "Symplicity G3" generator (Renal Denervation System)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 26 Nov 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28015
Adolfo Fontenla, MD, PhD, adolforamon.fontela@saludmadrid.org
About this study
Official title: Cardiac Sympathetic Neuromodulation by Renal Denervation in Hypertrophic Cardiomyopathy (SNYPER Pilot Study)
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.
Read the detailed description
According to current literature, approximately two-thirds of patients with HCM have persistent symptoms despite conventional treatment. For this reason, novel nonpharmacological therapies such as cardiac resynchronization, endocardial catheter ablation of the interventricular septum or needle-based septal ablation have been proposed, however, none of them having been generalized up to date. Besides, these novel therapies cannot be applied in non-obstructive HCM. The abnormal activation of the sympathetic system represents a relevant mechanism in he pathophysiology of HCM, since it may have implications in the progression and prognosis of the disease. The modulation of the cardiac sympathetic tone by renal denervation could be developed as a new therapeutic target for patients with persistent symptoms despite conventional treatment.
The SNYPER pilot study is a prospective, single-center, single-arm, pilot study, evaluating renal denervation in patients with sarcomeric HCM and persistent symptoms despite optimal therapy, over a follow-up period of 6 months. It represents a proof of concept that will quantify the degree in which renal denervation modulates cardiac sympathetic activity in HCM, thus opening a new research line: a non-pharmacological, minimally invasive and safe treatment with potential positive impact on health and well-being of patients with HCM.
This is a non-commercial, investigator-driven clinical study funded through a public competitive call by Health Institute Carlos III, Spanish Ministry of Economy (PI21/00480).
The study is coordinated by the main investigator from "University Hospital 12 de Octubre" in Madrid. Several responsibilities are delegated to the Clinical Research Unit ("University Hospital 12 de Octubre", Madrid, Spain).
The study was planned according to the Good Clinical Practices. SNYPER Pilot Study has been approved by the Ethics Committee and Spanish Health Authorities. All participating patients must give written informed consent before any study procedure occur.
- Conditions
- Hypertrophic Cardiomyopathy
- Being tested
- "Symplicity Spyral" multi-electrode renal denervation catheter and "Symplicity G3" generator (Renal Denervation System)
- Keywords
- renal denervation
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: "Symplicity Spyral" multi-electrode renal denervation catheter and "Symplicity G3" generator (Renal Denervation System) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac sympathetic nerve activity (123I-MIBG washout rate)
123I-MIBG washout rate measured by scintigraphy
Measured: 6 months
Secondary outcomes (10)
Functional status
New York Heart Association (NYHA) class. From I to IV (higher scores mean a worse outcome)
Measured: 6 months
Left ventricular mass
Left ventricular mass assessed by echocardiography (Devereux´s formula, septal and posterior wall thickness)
Measured: 6 months
Diastolic function
E / A ratio, deceleration time, E' septal and lateral velocity, E/E´ septal ratio, propagation velocity assessed by echocardiography
Measured: 6 months
Subaortic gradient (left ventricular outflow tract obstruction [LVOT])
Baseline peak LVOT gradient, peak LVOT gradient during Valsalva in millimeters of mercury
Measured: 6 months
Number of ventricular tachycardia episodes
Non-sustained ventricular tachycardias episodes recorded by a cardiac electronic implantable device (pacemaker or defibrillator, if previously implanted)
Measured: 6 months
Heart rate variability
Number of atrial premature complexes and number of non-sustained atrial tachycardias recorded by 24-hour Holter
Measured: 6 months
Maximum oxygen consumption
Maximum oxygen consumption assessed by ergospirometer
Measured: 6 months
Blood pressure
Mean, daily and nocturnal systolic and diastolic blood pressure assessed by 24-hour ambulatory monitoring of blood pressure (AMBP)
Measured: 6 months
NT-Pro-BNP
Serum NT-Pro-BNP levels
Measured: 6 months
Kansas City Cardiomyopathy Questionnaire (KCCQ) score
Self-administered health-related quality of life questionnaire composed by 23 items, which provides a score range from 0 to 100.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start26 Nov 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adolfo Fontenla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Adolfo Fontenla, Hospital Universitario 12 de Octubre
- Investigators
- Adolfo Fontenla, MD, PhD, Study chair, Hospital Universitario 12 de OctubreAdolfo Fontenla, MD, PhD, Principal investigator, Hospital Universitario 12 de Octubre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05577208
- Sponsor's protocol ID
- SNYPER-PS
- Acronym
- SNYPER-PS
- Status last verified
- Nov 2022
- First submitted
- 6 Oct 2022
- Last updated
- 29 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 10 milliliters (mL) of total blood, 5mL of serum and 10mL of blood with a commercial formula for RNA preservation shall be collected and stored for future proteomic and genetic analysis.
Publications
Lefroy DC, de Silva R, Choudhury L, Uren NG, Crake T, Rhodes CG, Lammertsma AA, Boyd H, Patsalos PN, Nihoyannopoulos P, et al. Diffuse reduction of myocardial beta-adrenoceptors in hypertrophic cardiomyopathy: a study with positron emission tomography. J Am Coll Cardiol. 1993 Nov 15;22(6):1653-60. doi: 10.1016/0735-1097(93)90591-n.
PubMed 8227834Schafers M, Dutka D, Rhodes CG, Lammertsma AA, Hermansen F, Schober O, Camici PG. Myocardial presynaptic and postsynaptic autonomic dysfunction in hypertrophic cardiomyopathy. Circ Res. 1998 Jan 9-23;82(1):57-62. doi: 10.1161/01.res.82.1.57.
PubMed 9440705Li ST, Tack CJ, Fananapazir L, Goldstein DS. Myocardial perfusion and sympathetic innervation in patients with hypertrophic cardiomyopathy. J Am Coll Cardiol. 2000 Jun;35(7):1867-73. doi: 10.1016/s0735-1097(00)00626-4.
PubMed 10841237Taki J, Nakajima K, Bunko H, Simizu M, Muramori A, Hisada K. Whole-body distribution of iodine 123 metaiodobenzylguanidine in hypertrophic cardiomyopathy: significance of its washout from the heart. Eur J Nucl Med. 1990;17(5):264-8. doi: 10.1007/BF00812368.
PubMed 2128050Pace L, Betocchi S, Losi MA, Della Morte AM, Ciampi Q, Nugnez R, Chiariello M, Salvatore M. Sympathetic nervous function in patients with hypertrophic cardiomyopathy assessed by [123I]-MIBG: relationship with left ventricular perfusion and function. Q J Nucl Med Mol Imaging. 2004 Mar;48(1):20-5.
PubMed 15195000Rapacciuolo A, Esposito G, Caron K, Mao L, Thomas SA, Rockman HA. Important role of endogenous norepinephrine and epinephrine in the development of in vivo pressure-overload cardiac hypertrophy. J Am Coll Cardiol. 2001 Sep;38(3):876-82. doi: 10.1016/s0735-1097(01)01433-4.
PubMed 11527648Shimizu M, Ino H, Okeie K, Yamaguchi M, Hayashi K, Nagata M, Itoh H, Iwaki T, Oe K, Konno T, Mabuchi H. Septal wall thinning and systolic dysfunction in patients with hypertrophic cardiomyopathy caused by a cardiac troponin I gene mutation. Am Heart J. 2002 Apr;143(4):690-5. doi: 10.1067/mhj.2002.120291.
PubMed 11923807Terai H, Shimizu M, Ino H, Yamaguchi M, Uchiyama K, Oe K, Nakajima K, Taki J, Kawano M, Mabuchi H. Changes in cardiac sympathetic nerve innervation and activity in pathophysiologic transition from typical to end-stage hypertrophic cardiomyopathy. J Nucl Med. 2003 Oct;44(10):1612-7.
PubMed 14530475Hiasa G, Hamada M, Saeki H, Ogimoto A, Ohtsuka T, Hara Y, Shigematsu Y. Cardiac sympathetic nerve activity can detect congestive heart failure sensitively in patients with hypertrophic cardiomyopathy. Chest. 2004 Sep;126(3):679-86. doi: 10.1378/chest.126.3.679.
PubMed 15364742Terai H, Shimizu M, Ino H, Yamaguchi M, Hayashi K, Sakata K, Kiyama M, Hayashi T, Inoue M, Taki J, Mabuchi H. Cardiac sympathetic nerve activity in patients with hypertrophic cardiomyopathy with malignant ventricular tachyarrhythmias. J Nucl Cardiol. 2003 May-Jun;10(3):304-10. doi: 10.1016/s1071-3581(03)00362-3.
PubMed 12794630Bhatt DL, Kandzari DE, O'Neill WW, D'Agostino R, Flack JM, Katzen BT, Leon MB, Liu M, Mauri L, Negoita M, Cohen SA, Oparil S, Rocha-Singh K, Townsend RR, Bakris GL; SYMPLICITY HTN-3 Investigators. A controlled trial of renal denervation for resistant hypertension. N Engl J Med. 2014 Apr 10;370(15):1393-401. doi: 10.1056/NEJMoa1402670. Epub 2014 Mar 29.
PubMed 24678939Kandzari DE, Bohm M, Mahfoud F, Townsend RR, Weber MA, Pocock S, Tsioufis K, Tousoulis D, Choi JW, East C, Brar S, Cohen SA, Fahy M, Pilcher G, Kario K; SPYRAL HTN-ON MED Trial Investigators. Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial. Lancet. 2018 Jun 9;391(10137):2346-2355. doi: 10.1016/S0140-6736(18)30951-6. Epub 2018 May 23.
PubMed 29803589Bohm M, Kario K, Kandzari DE, Mahfoud F, Weber MA, Schmieder RE, Tsioufis K, Pocock S, Konstantinidis D, Choi JW, East C, Lee DP, Ma A, Ewen S, Cohen DL, Wilensky R, Devireddy CM, Lea J, Schmid A, Weil J, Agdirlioglu T, Reedus D, Jefferson BK, Reyes D, D'Souza R, Sharp ASP, Sharif F, Fahy M, DeBruin V, Cohen SA, Brar S, Townsend RR; SPYRAL HTN-OFF MED Pivotal Investigators. Efficacy of catheter-based renal denervation in the absence of antihypertensive medications (SPYRAL HTN-OFF MED Pivotal): a multicentre, randomised, sham-controlled trial. Lancet. 2020 May 2;395(10234):1444-1451. doi: 10.1016/S0140-6736(20)30554-7. Epub 2020 Mar 29.
PubMed 32234534Fontenla A, Garcia-Donaire JA, Hernandez F, Segura J, Salgado R, Cerezo C, Ruilope LM, Arribas F. Management of resistant hypertension in a multidisciplinary unit of renal denervation: protocol and results. Rev Esp Cardiol (Engl Ed). 2013 May;66(5):364-70. doi: 10.1016/j.rec.2012.09.006. Epub 2012 Dec 11.
PubMed 24775818Rodriguez-Leor O, Segura J, Garcia Donaire JA, Gutierrez-Ibanes E, Oliveras A, Mediavilla JD, Serrador A, Prado JC, Nunez-Gil I, Diez-Delhoyo F, Clara Velasco A, Jaen Aguila F, Amat-Santos I, Bayes-Genis A, Troya Saborido MI. Renal denervation for the treatment of resistant hypertension in Spain. The Flex-Spyral Registry. Rev Esp Cardiol (Engl Ed). 2020 Aug;73(8):615-622. doi: 10.1016/j.rec.2019.08.001. Epub 2019 Sep 24. English, Spanish.
PubMed 31561981
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Sympathetic Neuromodulation by Renal Denervation in Hypertrophic Cardiomyopathy (SNYPER Pilot Study)
- ClinicalTrials.gov ID
- NCT05577208
- Acronym / sponsor ID
- SNYPER-PS / SNYPER-PS
- Conditions
- Hypertrophic Cardiomyopathy
- Keywords
- renal denervation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Adolfo FontenlaUniversity, hospital or other
- Study start
- 26 Nov 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 13 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
According to current literature, approximately two-thirds of patients with HCM have persistent symptoms despite conventional treatment. For this reason, novel nonpharmacological therapies such as cardiac resynchronization, endocardial catheter ablation of the interventricular septum or needle-based septal ablation have been proposed, however, none of them having been generalized up to date. Besides, these novel therapies cannot be applied in non-obstructive HCM. The abnormal activation of the sympathetic system represents a relevant mechanism in he pathophysiology of HCM, since it may have implications in the progression and prognosis of the disease. The modulation of the cardiac sympathetic tone by renal denervation could be developed as a new therapeutic target for patients with persistent symptoms despite conventional treatment.
The SNYPER pilot study is a prospective, single-center, single-arm, pilot study, evaluating renal denervation in patients with sarcomeric HCM and persistent symptoms despite optimal therapy, over a follow-up period of 6 months. It represents a proof of concept that will quantify the degree in which renal denervation modulates cardiac sympathetic activity in HCM, thus opening a new research line: a non-pharmacological, minimally invasive and safe treatment with potential positive impact on health and well-being of patients with HCM.
This is a non-commercial, investigator-driven clinical study funded through a public competitive call by Health Institute Carlos III, Spanish Ministry of Economy (PI21/00480).
The study is coordinated by the main investigator from "University Hospital 12 de Octubre" in Madrid. Several responsibilities are delegated to the Clinical Research Unit ("University Hospital 12 de Octubre", Madrid, Spain).
The study was planned according to the Good Clinical Practices. SNYPER Pilot Study has been approved by the Ethics Committee and Spanish Health Authorities. All participating patients must give written informed consent before any study procedure occur.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| renal denervation | Experimental | Device: "Symplicity Spyral" multi-electrode renal denervation catheter and "Symplicity G3" generator (Renal Denervation System)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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Symplicity Spyral" multi-electrode renal denervation catheter and "Symplicity G3" generator (Renal Denervation System)Minimally invasive percutaneous interventional therapy aimed to modulate the sympathetic nervous system through endovascular ablation of both renal arteries | Device | renal denervation |
Primary outcome
Cardiac sympathetic nerve activity (123I-MIBG washout rate)
Time frame: 6 months
123I-MIBG washout rate measured by scintigraphy
10 secondary outcomes
Functional status
Time frame: 6 months
Left ventricular mass
Time frame: 6 months
Diastolic function
Time frame: 6 months
Subaortic gradient (left ventricular outflow tract obstruction [LVOT])
Time frame: 6 months
Number of ventricular tachycardia episodes
Time frame: 6 months
Heart rate variability
Time frame: 6 months
Maximum oxygen consumption
Time frame: 6 months
Blood pressure
Time frame: 6 months
NT-Pro-BNP
Time frame: 6 months
Kansas City Cardiomyopathy Questionnaire (KCCQ) score
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
- Background: PubMed 8227834Lefroy DC, de Silva R, Choudhury L, Uren NG, Crake T, Rhodes CG, Lammertsma AA, Boyd H, Patsalos PN, Nihoyannopoulos P, et al. Diffuse reduction of myocardial beta-adrenoceptors in hypertrophic cardiomyopathy: a study with positron emission tomography. J Am Coll Cardiol. 1993 Nov 15;22(6):1653-60. doi: 10.1016/0735-1097(93)90591-n.
- Background: PubMed 9440705Schafers M, Dutka D, Rhodes CG, Lammertsma AA, Hermansen F, Schober O, Camici PG. Myocardial presynaptic and postsynaptic autonomic dysfunction in hypertrophic cardiomyopathy. Circ Res. 1998 Jan 9-23;82(1):57-62. doi: 10.1161/01.res.82.1.57.
- Background: PubMed 10841237Li ST, Tack CJ, Fananapazir L, Goldstein DS. Myocardial perfusion and sympathetic innervation in patients with hypertrophic cardiomyopathy. J Am Coll Cardiol. 2000 Jun;35(7):1867-73. doi: 10.1016/s0735-1097(00)00626-4.
- Background: PubMed 2128050Taki J, Nakajima K, Bunko H, Simizu M, Muramori A, Hisada K. Whole-body distribution of iodine 123 metaiodobenzylguanidine in hypertrophic cardiomyopathy: significance of its washout from the heart. Eur J Nucl Med. 1990;17(5):264-8. doi: 10.1007/BF00812368.
- Background: PubMed 15195000Pace L, Betocchi S, Losi MA, Della Morte AM, Ciampi Q, Nugnez R, Chiariello M, Salvatore M. Sympathetic nervous function in patients with hypertrophic cardiomyopathy assessed by [123I]-MIBG: relationship with left ventricular perfusion and function. Q J Nucl Med Mol Imaging. 2004 Mar;48(1):20-5.
- Background: PubMed 11527648Rapacciuolo A, Esposito G, Caron K, Mao L, Thomas SA, Rockman HA. Important role of endogenous norepinephrine and epinephrine in the development of in vivo pressure-overload cardiac hypertrophy. J Am Coll Cardiol. 2001 Sep;38(3):876-82. doi: 10.1016/s0735-1097(01)01433-4.
- Background: PubMed 11923807Shimizu M, Ino H, Okeie K, Yamaguchi M, Hayashi K, Nagata M, Itoh H, Iwaki T, Oe K, Konno T, Mabuchi H. Septal wall thinning and systolic dysfunction in patients with hypertrophic cardiomyopathy caused by a cardiac troponin I gene mutation. Am Heart J. 2002 Apr;143(4):690-5. doi: 10.1067/mhj.2002.120291.
- Background: PubMed 14530475Terai H, Shimizu M, Ino H, Yamaguchi M, Uchiyama K, Oe K, Nakajima K, Taki J, Kawano M, Mabuchi H. Changes in cardiac sympathetic nerve innervation and activity in pathophysiologic transition from typical to end-stage hypertrophic cardiomyopathy. J Nucl Med. 2003 Oct;44(10):1612-7.
- Background: PubMed 15364742Hiasa G, Hamada M, Saeki H, Ogimoto A, Ohtsuka T, Hara Y, Shigematsu Y. Cardiac sympathetic nerve activity can detect congestive heart failure sensitively in patients with hypertrophic cardiomyopathy. Chest. 2004 Sep;126(3):679-86. doi: 10.1378/chest.126.3.679.
- Background: PubMed 12794630Terai H, Shimizu M, Ino H, Yamaguchi M, Hayashi K, Sakata K, Kiyama M, Hayashi T, Inoue M, Taki J, Mabuchi H. Cardiac sympathetic nerve activity in patients with hypertrophic cardiomyopathy with malignant ventricular tachyarrhythmias. J Nucl Cardiol. 2003 May-Jun;10(3):304-10. doi: 10.1016/s1071-3581(03)00362-3.
- Background: PubMed 24678939Bhatt DL, Kandzari DE, O'Neill WW, D'Agostino R, Flack JM, Katzen BT, Leon MB, Liu M, Mauri L, Negoita M, Cohen SA, Oparil S, Rocha-Singh K, Townsend RR, Bakris GL; SYMPLICITY HTN-3 Investigators. A controlled trial of renal denervation for resistant hypertension. N Engl J Med. 2014 Apr 10;370(15):1393-401. doi: 10.1056/NEJMoa1402670. Epub 2014 Mar 29.
- Background: PubMed 29803589Kandzari DE, Bohm M, Mahfoud F, Townsend RR, Weber MA, Pocock S, Tsioufis K, Tousoulis D, Choi JW, East C, Brar S, Cohen SA, Fahy M, Pilcher G, Kario K; SPYRAL HTN-ON MED Trial Investigators. Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial. Lancet. 2018 Jun 9;391(10137):2346-2355. doi: 10.1016/S0140-6736(18)30951-6. Epub 2018 May 23.
- Individual participant dataSharing planned: Yes. 10 milliliters (mL) of total blood, 5mL of serum and 10mL of blood with a commercial formula for RNA preservation shall be collected and stored for future proteomic and genetic analysis.
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RecruitingObservational study
A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease
Coronary Artery Disease, Myocarditis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adolfo Fontenla, MD, PhD study chair
Hospital Universitario 12 de Octubre
Adolfo Fontenla, MD, PhD principal investigator
Hospital Universitario 12 de Octubre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Symplicity Spyral" multi-electrode renal denervation catheter and "Symplicity G3" generator (Renal Denervation System) in people with Hypertrophic Cardiomyopathy, run by Adolfo Fontenla at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adolfo Fontenla, MD, PhD (+34699012607, adolforamon.fontela@saludmadrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac sympathetic nerve activity (123I-MIBG washout rate) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05577208, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2022.