Heart Failure, DiastolicNCT02115230
Renal Denervation in Patients With Heart Failure With Normal LV Ejection Fraction
A study testing Renal denervation + medical therapy in people with Heart Failure, Diastolic and Hypertension, 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 Heart Failure With Normal LV Ejection Fraction. The purpose of the study is to evaluate the safety and effectiveness of renal denervation in patients with Heart Failure With Normal LV Ejection Fraction, due to reduction… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Failure, Diastolic, Hypertension
- What is being tested?
- Renal denervation + medical therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2014to Jul 2016
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hypertension treated with at least 2 antihypertensive drugs;
- Heart failure with a normal LV ejection fraction;
- Left Ventricular Hypertrophy (LV mass index > 96 g/m2 in women and > 116 g/m2 in men);
- ≥ 18 years of age;
Who cannot join
- Known secondary cause of hypertension
- Uncontrolled blood pressure (≥ 180x110mmHg)
- Unsuitable anatomy of renal arteries, renal stenosis or previous treatment with balloon or stent
- Advanced renal insufficiency (estimated glomerular filtration rate (GFR) < 30 ml/min/1.73 square meters)
- Diabetes Mellitus type 1
- Acute coronary syndrome or a cerebrovascular accident in the last 6 months
Show all 13Show fewer
- Known other cause of respiratory dysfunction
- Previous LV systolic dysfunction (LVEF < 50%)
- Restrictive cardiomyopathy or Hypertrophic cardiomyopathy
- Significant valvar dysfunction
- Atrial flutter or atrial fibrillation
- Use of the oral anticoagulants
- Drug and Alcohol dependence
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 Heart Failure With Normal Left Ventricular Ejection Fraction - a Safety and Efficacy Study of Irrigated Radiofrequency Catheter
It is a randomized prospective controlled study of transcatheter renal denervation in patients with Heart Failure With Normal LV Ejection Fraction. The purpose of the study is to evaluate the safety and effectiveness of renal denervation in patients with Heart Failure With Normal LV Ejection Fraction, due to reduction in renal and systemic sympathetic activity.
- Conditions
- Heart Failure, Diastolic, Hypertension
- Being tested
- Renal denervation + medical therapy
- Keywords
- Heart Failure, Heart Failure, Diastolic, Hypertension, Renal Denervation, Irrigated Radiofrequency Catheter
- Medical subject headings
- Heart Failure, Diastolic, Hypertension, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal denervation + medical therapyProcedure or surgery
Renal denervation + medical therapy Renal sympathetic denervation with an irrigated radiofrequency catheter with Celsius Thermocool (Biosense Webster, California, USA) + standard optimized medical therapy for diastolic heart failure
| Study group | Role | What they receive |
|---|---|---|
| Renal denervation + medical therapy | Experimental | Renal sympathetic denervation with an irrigated radiofrequency catheter with Celsius Thermocool (Biosense Webster, California, USA) + standard optimized medical therapy for diastolic heart failure Receives: Procedure: Renal denervation + medical therapy |
| Medical therapy | No intervention | Standard optimized medical therapy for diastolic heart failure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Change from baseline E/E' on echocardiography at 12 months
Measured: 12 months after treatment
Safety: Composite of death, myocardial infarction, cerebrovascular event, need of intervention on renal arteries and renal function impairment (decrease in estimated GFR > 30% from baseline)
Measured: 12 months
Secondary outcomes (9)
Change from baseline E/E' on echocardiography at 6 months
Measured: 6 months
Change of office blood pressure and ambulatory blood pressure monitoring (ABPM) between baseline and 12 months
Measured: 12 months
Change in any echocardiographic diastolic parameter between baseline and 12 months
Measured: 12 months
Change in 6 min walking distance between baseline and 12 months
Measured: 12 months
Change in quality of life (Minnesota Living with Heart Failure Questionnaire) between baseline and 12 months
Measured: 12 months
Change in serum B-type natriuretic peptide (BNP) between baseline and 12 months
Measured: 12 months
Change in peripheral sympathetic activity measured by microneurography between baseline and 12 months
Measured: 12 months
Change in non-invasive hemodynamic parameters provided by Finometer between baseline and 12 months
Measured: 12 months
Change in renal function (GFR, albuminury and 24h urinary Na excretion) between baseline and 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, DiastolicStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InCor Heart Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedro A. Lemos, InCor Heart Institute
- Investigators
- Pedro A Lemos, MD PhD, Study chair, Heart Institute - InCor. University of Sao Paulo Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02115230
- Sponsor's protocol ID
- IncorRDN-ICFEN
- Status last verified
- Apr 2014
- First submitted
- 13 Apr 2014
- Last updated
- 15 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcatheter Renal Denervation in Heart Failure With Normal Left Ventricular Ejection Fraction - a Safety and Efficacy Study of Irrigated Radiofrequency Catheter
- ClinicalTrials.gov ID
- NCT02115230
- Acronym / sponsor ID
- IncorRDN-ICFEN
- Conditions
- Heart Failure, Diastolic, Hypertension
- Keywords
- Heart Failure, Heart Failure, Diastolic, Hypertension, Renal Denervation, Irrigated Radiofrequency Catheter
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- InCor Heart InstituteUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jul 2016 (estimated)
- First posted
- 15 Apr 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 Heart Failure With Normal LV Ejection Fraction. The purpose of the study is to evaluate the safety and effectiveness of renal denervation in patients with Heart Failure With Normal LV Ejection Fraction, due to reduction in renal and systemic sympathetic activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renal denervation + medical therapy | Experimental | Procedure: Renal denervation + medical therapyRenal sympathetic denervation with an irrigated radiofrequency catheter with Celsius Thermocool (Biosense Webster, California, USA) + standard optimized medical therapy for diastolic heart failure |
| Medical therapy | No intervention | –Standard optimized medical therapy for diastolic heart failure |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hypertension treated with at least 2 antihypertensive drugs;
- Heart failure with a normal LV ejection fraction;
- Left Ventricular Hypertrophy (LV mass index > 96 g/m2 in women and > 116 g/m2 in men);
- ≥ 18 years of age;
Key exclusion criteria (13 listed)
- Known secondary cause of hypertension
- Uncontrolled blood pressure (≥ 180x110mmHg)
- Unsuitable anatomy of renal arteries, renal stenosis or previous treatment with balloon or stent
- Advanced renal insufficiency (estimated glomerular filtration rate (GFR) < 30 ml/min/1.73 square meters)
- Diabetes Mellitus type 1
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 |
|---|---|---|
| Renal denervation + medical therapyRenal denervation + medical therapy Renal sympathetic denervation with an irrigated radiofrequency catheter with Celsius Thermocool (Biosense Webster, California, USA) + standard optimized medical therapy for diastolic heart failure | Procedure or surgery | Renal denervation + medical therapy |
Primary outcome
Efficacy: Change from baseline E/E' on echocardiography at 12 months
Time frame: 12 months after treatment
Safety: Composite of death, myocardial infarction, cerebrovascular event, need of intervention on renal arteries and renal function impairment (decrease in estimated GFR > 30% from baseline)
Time frame: 12 months
9 secondary outcomes
Change from baseline E/E' on echocardiography at 6 months
Time frame: 6 months
Change of office blood pressure and ambulatory blood pressure monitoring (ABPM) between baseline and 12 months
Time frame: 12 months
Change in any echocardiographic diastolic parameter between baseline and 12 months
Time frame: 12 months
Change in 6 min walking distance between baseline and 12 months
Time frame: 12 months
Change in quality of life (Minnesota Living with Heart Failure Questionnaire) between baseline and 12 months
Time frame: 12 months
Change in serum B-type natriuretic peptide (BNP) between baseline and 12 months
Time frame: 12 months
Change in peripheral sympathetic activity measured by microneurography between baseline and 12 months
Time frame: 12 months
Change in non-invasive hemodynamic parameters provided by Finometer between baseline and 12 months
Time frame: 12 months
Change in renal function (GFR, albuminury and 24h urinary Na excretion) between baseline and 12 months
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2014.
Related trials for Heart Failure, Diastolic
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
RecruitingPhase 1
A Study of LY3971297 in Participants With Heart Failure
Heart Failure, Heart Failure, Diastolic
Not yet recruiting
Importance of Point-of-Care Ultrasound for Early Detection of Valvular and Cardiac Diseases (IMPROVE)
Valvular Heart Disease Patients, Aortic Stenosis
Recruiting
PrEcision Pacing in HFpEF: the PEP-HFpEF Trial
Heart Failure and Preserved Ejection Fraction, Heart Failure New York Heart Association Class III
Recruiting
Assessment of CCM in HF With Higher Ejection Fraction
Heart Failure, Heart Failure With Preserved Ejection Fraction
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
Pedro A Lemos, MD PhD study chair
Heart Institute - InCor. University of Sao Paulo Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Renal denervation + medical therapy in people with Heart Failure, Diastolic and Hypertension, 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 4 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 15 Apr 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?
Efficacy: Change from baseline E/E' on echocardiography at 12 months (time frame: 12 months after treatment). The study lists 2 primary outcomes in all. 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 15 Apr 2014.