Essential HypertensionRENONCT01617551
Effect of Renal Denervation on NO-mediated Sodium Excretion and Plasma Levels of Vasoactive Hormones
A study testing NG-monomethyl-L-arginine (L-NMMA) in people with Essential Hypertension, run by Regional Hospital Holstebro at 1 site in Denmark.
Trial summary
Catheter based renal denervation (CRD) in humans represents a promising new treatment of resistant hypertension. CRD is currently investigated as a treatment option in patients with resistant hypertension defined as at least 3 antihypertensive drugs (including a diuretic) in a randomized, sham-controlled, multicenter… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- NG-monomethyl-L-arginine (L-NMMA)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2012to Jun 2014
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 30-70 years
- Stable antihypertensive treatment for 1-month with at least 3 antihypertensive drugs including a diuretic
- Day-time ambulatory blood pressure > 145/75 mmHg
Who cannot join
- Non compliance
- Pregnancy/no-anticonception in fertile women
- Radiocontrast allergy
- Malignancy
- Congestive heart failure (EF < 50)
- eGFR < 45
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- Unstable angina pectoris
- Recent myocardial infarction or PCI (< 6 mdr)
- Secondary hypertension
- Renal artery stenosis or multiple renal arteries on CT
- Claudication
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Dept. of medical research
Holstebro, 7500
Jesper N Bech, MD, Ph.D
About this study
Official title: Effect of Renal Denervation on NO-mediated Regulation of Salt- and Water Excretion, Vasoactive Hormones and Tubular Transport Proteins in Patients With Resistant Hypertension
Catheter based renal denervation (CRD) in humans represents a promising new treatment of resistant hypertension. CRD is currently investigated as a treatment option in patients with resistant hypertension defined as at least 3 antihypertensive drugs (including a diuretic) in a randomized, sham-controlled, multicenter trial in Denmark (ReSet). In ReSet, patients are randomized to either CRD or a sham procedure with 6 months follow up. The mechanisms by which CRD reduce blood pressure are only partly understood and the interaction between renal sympathetic nerves and nitric oxide (NO) has not been investigated in humans.
To Study the interaction between NO and renal sympathetic nerves, we designed the present substudy, where the effects of NO-inhibition on renal, hemodynamic and hormonal variables are studied before and after CRD.
- Conditions
- Essential Hypertension
- Being tested
- NG-monomethyl-L-arginine (L-NMMA)
- Keywords
- Essential hypertension, Nitric oxide, Renal denervation, Sodium, GFR
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NG-monomethyl-L-arginine (L-NMMA)Drug
Acute L-NMMA treatment (4,5 mg/kg loading dose followed by 3 mg/kg sustain infusion for 1 hour)
| Study group | Role | What they receive |
|---|---|---|
| Renal denervation | Experimental | Patient group randomized to renal denervation Receives: Drug: NG-monomethyl-L-arginine (L-NMMA) |
| Sham | Sham comparator | Patients randomized to sham procedure Receives: Drug: NG-monomethyl-L-arginine (L-NMMA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional excretion of sodium after acute L-NMMA treatment
Measured: 1 month before and after CRD
Secondary outcomes (1)
Glomerular filtration rate (GFR) before and after L-NMMA treatment
Measured: 1 month before and after CRD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential HypertensionStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regional Hospital Holstebro
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Principal investigator, Erling Bjerregaard Pedersen, Regional Hospital Holstebro
- Investigators
- Jesper N Bech, MD, Ph.D, Principal investigator, Dept. of medical research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01617551
- Sponsor's protocol ID
- RENO_01
- Acronym
- RENO
- Status last verified
- Mar 2014
- First submitted
- 6 Jun 2012
- Last updated
- 4 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Renal Denervation on NO-mediated Regulation of Salt- and Water Excretion, Vasoactive Hormones and Tubular Transport Proteins in Patients With Resistant Hypertension
- ClinicalTrials.gov ID
- NCT01617551
- Acronym / sponsor ID
- RENO / RENO_01
- Conditions
- Essential Hypertension
- Keywords
- Essential hypertension, Nitric oxide, Renal denervation, Sodium, GFR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Regional Hospital HolstebroUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- Mar 2012
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 12 Jun 2012 (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.
Catheter based renal denervation (CRD) in humans represents a promising new treatment of resistant hypertension. CRD is currently investigated as a treatment option in patients with resistant hypertension defined as at least 3 antihypertensive drugs (including a diuretic) in a randomized, sham-controlled, multicenter trial in Denmark (ReSet). In ReSet, patients are randomized to either CRD or a sham procedure with 6 months follow up. The mechanisms by which CRD reduce blood pressure are only partly understood and the interaction between renal sympathetic nerves and nitric oxide (NO) has not been investigated in humans.
To Study the interaction between NO and renal sympathetic nerves, we designed the present substudy, where the effects of NO-inhibition on renal, hemodynamic and hormonal variables are studied before and after CRD.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renal denervation | Experimental | Drug: NG-monomethyl-L-arginine (L-NMMA)Patient group randomized to renal denervation |
| Sham | Sham comparator | Drug: NG-monomethyl-L-arginine (L-NMMA)Patients randomized to sham procedure |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 30-70 years
- Stable antihypertensive treatment for 1-month with at least 3 antihypertensive drugs including a diuretic
- Day-time ambulatory blood pressure > 145/75 mmHg
Key exclusion criteria (11 listed)
- Non compliance
- Pregnancy/no-anticonception in fertile women
- Radiocontrast allergy
- Malignancy
- Congestive heart failure (EF < 50)
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 |
|---|---|---|
| NG-monomethyl-L-arginine (L-NMMA)Acute L-NMMA treatment (4,5 mg/kg loading dose followed by 3 mg/kg sustain infusion for 1 hour) | Drug | Renal denervation, Sham |
Primary outcome
Fractional excretion of sodium after acute L-NMMA treatment
Time frame: 1 month before and after CRD
1 secondary outcome
Glomerular filtration rate (GFR) before and after L-NMMA treatment
Time frame: 1 month before and after CRD
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 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.
Jesper N Bech, MD, Ph.D principal investigator
Dept. of medical research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NG-monomethyl-L-arginine (L-NMMA) in people with Essential Hypertension, run by Regional Hospital Holstebro at 1 site in Denmark.
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 3 inclusion and 11 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 4 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 Denmark. 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. Some participants in this study may receive a placebo. 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 Jesper N Bech, MD, Ph.D (+45 41627639, jnbech@dadlnet.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fractional excretion of sodium after acute L-NMMA treatment (time frame: 1 month before and after CRD). 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 4 Mar 2014.