Heart FailureNCT02099903
Renal Denervation in Patients With Heart Failure Secondary to Chagas Disease
A study testing transcatheter renal denervation in people with Heart Failure and Heart Failure, Systolic, run by InCor Heart Institute at 1 site in Brazil.
Trial summary
It is a randomized prospective controlled study of transcatheter renal denervation in patients with systolic heart failure secondary to Chagas' disease. The purpose of the study is to evaluate the safety and effectiveness of renal denervation in patients with Chagas heart disease, due to reduction in renal and… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Heart Failure, Heart Failure, Systolic, Chagas Disease
- What is being tested?
- transcatheter renal denervation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2014to Aug 2015
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 to ≤ 70 years of age with chronic systolic heart failure, Chagas disease etiology.
- Two positive serology results for Chagas by two distinct methods.
- NYHA (New York Heart Association) class II or III.
- Patients treated with maximum tolerated doses of standard pharmacotherapy for heart failure.
- LVEF (Left Ventricular Ejection Fraction) ≤ 40% (Simpson Method).
Who cannot join
- Patients with NYHA class I or IV.
- Sustained ventricular tachycardia (>30 sec) or with hemodynamic compromise.
- Presence of permanent pacemaker or implantable defibrillator.
- Systolic blood pressure < 90 mmHg.
- Heart beat < 60 bpm at rest.
- Advanced renal insufficiency (estimated glomerular filtration rate (GFR) < 30 ml/min/1.73 square meters).
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- Patients with planned cardiac surgery or percutaneous revascularization.
- Other reasons which would preclude the patient from participating in the study (comorbidities, life expectancy less than 1 year).
- Unsuitable anatomy of renal arteries, renal stenosis or previous treatment with balloon or stent.
- Refusal of the patient.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Heart Institute - InCor. University of Sao Paulo Medical School
São Paulo, São Paulo, 05403-000
Patricia Pereira, +55 11 2661-5368, patricia.pereira@incor.usp.br
Pedro Lemos, MD PhD
About this study
Official title: Transcatheter Renal Denervation in Patients With Systolic Heart Failure Due to Chagas' Disease - a Safety and Efficacy Study.
It is a randomized prospective controlled study of transcatheter renal denervation in patients with systolic heart failure secondary to Chagas' disease. The purpose of the study is to evaluate the safety and effectiveness of renal denervation in patients with Chagas heart disease, due to reduction in renal and systemic sympathetic activity.
Read the detailed description
The activation of the sympathetic nervous system is one of the main mechanisms involved in heart failure pathophysiology, as well as activation of the renin-angiotensin-aldosterone system. These compensatory mechanisms are initially beneficial, in order to restore adequate cardiac output. Their long-term activation, nevertheless, leads to several deleterious effects on cardiovascular system, such as direct myocite lesion, cardiac hypertrophy, myocardial ischemia, oxidative stress, cardiac arrhythmias and myocite apoptosis, among others.
It has been widely demonstrated that modulation of sympathetic nervous system is an important therapeutic target for the treatment of systolic heart failure. Beta-blocker and ACE inhibitors therapies are the main stem of heart failure treatment and have demonstrated reduction in morbidity and mortality of this condition. Despite optimized medical treatment, heart failure carries a poor prognosis.
Surgical sympathectomy has been used decades ago for the treatment of malignant hypertension and showed marked reduction in arterial pressure. However, these procedures were very aggressive and lead to long hospitalization and recovery periods, as well as several limiting adverse effects. Recently, transcatheter renal denervation has evolved as a promising and less invasive technique, which allows destruction of renal nerves located on the adventitia of the renal arteries. The ablation procedure is performed by delivery of radiofrequency energy from the tip of a catheter positioned into the renal arteries, through standard femoral artery catheterization, a less morbid and safer approach.
Renal denervation has been tested mainly in patients with resistant hypertension, among other indications, with promising results. The pathophysiological basis for this treatment in hypertension, as well as heart failure, stands on the participation of renal afferent and efferent nerves on the maintenance of elevated systemic vascular resistance. Activation of efferent nerves leads to excretion o renin, aldosterone, angiotensin II, elevated norepinephrine levels and consequent retention of salt and water and reduction of renal blood flow. This mechanism and also afferent renal nerves activation contributes to the elevation of sympathetic tonus on the central nervous system.
In animal models of heart failure, renal denervation demonstrated improvement on renal and cardiac function. Initial clinical studies suggest that this intervention is safe and potentially effective on the treatment of heart failure in humans. Chagas heart disease is a prevalent cause of heart failure in Brazil and shares several pathophysiological aspects described for other causes of heart failure. Our aim is to evaluate the safety and effectiveness of renal denervation in systolic heart failure due to Chagas Heart disease.
- Being tested
- transcatheter renal denervation
- Keywords
- Heart Failure, Heart Failure, Systolic, Chagas Disease, Chagas Cardiomyopathy, Renal Denervation, Irrigated Radiofrequency Catheter
- Medical subject headings
- Heart Failure, Heart Failure, Systolic, Chagas Disease, Chagas Cardiomyopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcatheter renal denervationDevice
Also called Celsius Thermocool (Biosense Webster, California, USA)
Renal sympathetic denervation with an irrigated radiofrequency catheter.
| Study group | Role | What they receive |
|---|---|---|
| Medical therapy for heart failure | No intervention | Standard optimized medical therapy for heart failure. |
| Renal denervation + medical therapy. | Experimental | Transcatheter Renal Denervation with irrigated radiofrequency catheter + standard medical therapy. Receives: Device: transcatheter renal denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite: death, myocardial infarction, cerebrovascular event, need of intervention on renal arteries and renal function impairment (decrease in estimated GFR > 30% from baseline).
Measured: 30 days.
Secondary outcomes (4)
Left Ventricular Ejection Fraction (LVEF) by echocardiography.
Measured: 9 months.
New York Heart Association (NYHA) functional class.
Measured: 9 months.
6-minute walk test
Measured: 9 months.
Peak Oxygen consumption (VO2) by ergoespirometry.
Measured: 9 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2014 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InCor Heart Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson
- Responsible party
- Principal investigator, Pedro A. Lemos, InCor Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02099903
- Sponsor's protocol ID
- 18400613.1.0000.0068
- Status last verified
- Mar 2014
- First submitted
- 19 Mar 2014
- Last updated
- 31 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcatheter Renal Denervation in Patients With Systolic Heart Failure Due to Chagas' Disease - a Safety and Efficacy Study.
- ClinicalTrials.gov ID
- NCT02099903
- Acronym / sponsor ID
- 18400613.1.0000.0068
- Keywords
- Heart Failure, Heart Failure, Systolic, Chagas Disease, Chagas Cardiomyopathy, Renal Denervation, Irrigated Radiofrequency Catheter
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- InCor Heart InstituteUniversity, hospital or other
- Collaborators
- Johnson & Johnson
- Study start
- Mar 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 31 Mar 2014 (estimated)
- 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.
It is a randomized prospective controlled study of transcatheter renal denervation in patients with systolic heart failure secondary to Chagas' disease. The purpose of the study is to evaluate the safety and effectiveness of renal denervation in patients with Chagas heart disease, due to reduction in renal and systemic sympathetic activity.
Detailed description
The activation of the sympathetic nervous system is one of the main mechanisms involved in heart failure pathophysiology, as well as activation of the renin-angiotensin-aldosterone system. These compensatory mechanisms are initially beneficial, in order to restore adequate cardiac output. Their long-term activation, nevertheless, leads to several deleterious effects on cardiovascular system, such as direct myocite lesion, cardiac hypertrophy, myocardial ischemia, oxidative stress, cardiac arrhythmias and myocite apoptosis, among others.
It has been widely demonstrated that modulation of sympathetic nervous system is an important therapeutic target for the treatment of systolic heart failure. Beta-blocker and ACE inhibitors therapies are the main stem of heart failure treatment and have demonstrated reduction in morbidity and mortality of this condition. Despite optimized medical treatment, heart failure carries a poor prognosis.
Surgical sympathectomy has been used decades ago for the treatment of malignant hypertension and showed marked reduction in arterial pressure. However, these procedures were very aggressive and lead to long hospitalization and recovery periods, as well as several limiting adverse effects. Recently, transcatheter renal denervation has evolved as a promising and less invasive technique, which allows destruction of renal nerves located on the adventitia of the renal arteries. The ablation procedure is performed by delivery of radiofrequency energy from the tip of a catheter positioned into the renal arteries, through standard femoral artery catheterization, a less morbid and safer approach.
Renal denervation has been tested mainly in patients with resistant hypertension, among other indications, with promising results. The pathophysiological basis for this treatment in hypertension, as well as heart failure, stands on the participation of renal afferent and efferent nerves on the maintenance of elevated systemic vascular resistance. Activation of efferent nerves leads to excretion o renin, aldosterone, angiotensin II, elevated norepinephrine levels and consequent retention of salt and water and reduction of renal blood flow. This mechanism and also afferent renal nerves activation contributes to the elevation of sympathetic tonus on the central nervous system.
In animal models of heart failure, renal denervation demonstrated improvement on renal and cardiac function. Initial clinical studies suggest that this intervention is safe and potentially effective on the treatment of heart failure in humans. Chagas heart disease is a prevalent cause of heart failure in Brazil and shares several pathophysiological aspects described for other causes of heart failure. Our aim is to evaluate the safety and effectiveness of renal denervation in systolic heart failure due to Chagas Heart disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical therapy for heart failure | No intervention | –Standard optimized medical therapy for heart failure. |
| Renal denervation + medical therapy. | Experimental | Device: transcatheter renal denervationTranscatheter Renal Denervation with irrigated radiofrequency catheter + standard medical therapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients ≥ 18 to ≤ 70 years of age with chronic systolic heart failure, Chagas disease etiology.
- Two positive serology results for Chagas by two distinct methods.
- NYHA (New York Heart Association) class II or III.
- Patients treated with maximum tolerated doses of standard pharmacotherapy for heart failure.
- LVEF (Left Ventricular Ejection Fraction) ≤ 40% (Simpson Method).
Key exclusion criteria (10 listed)
- Patients with NYHA class I or IV.
- Sustained ventricular tachycardia (>30 sec) or with hemodynamic compromise.
- Presence of permanent pacemaker or implantable defibrillator.
- Systolic blood pressure < 90 mmHg.
- Heart beat < 60 bpm at rest.
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 |
|---|---|---|
| transcatheter renal denervationAlso: Celsius Thermocool (Biosense Webster, California, USA)Renal sympathetic denervation with an irrigated radiofrequency catheter. | Device | Renal denervation + medical therapy. |
Primary outcome
Composite: death, myocardial infarction, cerebrovascular event, need of intervention on renal arteries and renal function impairment (decrease in estimated GFR > 30% from baseline).
Time frame: 30 days.
4 secondary outcomes
Left Ventricular Ejection Fraction (LVEF) by echocardiography.
Time frame: 9 months.
New York Heart Association (NYHA) functional class.
Time frame: 9 months.
6-minute walk test
Time frame: 9 months.
Peak Oxygen consumption (VO2) by ergoespirometry.
Time frame: 9 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2014.
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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.
Heart Institute - InCor. University of Sao Paulo Medical School
São Paulo, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcatheter renal denervation in people with Heart Failure and Heart Failure, Systolic, run by InCor Heart Institute at 1 site in Brazil.
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 10 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 31 Mar 2014. 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 Brazil. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite: death, myocardial infarction, cerebrovascular event, need of intervention on renal arteries and renal function impairment (decrease in estimated GFR > 30% from baseline). (time frame: 30 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2014.