Essential HypertensionhassNCT01195805
The Effects of Amiloride and Spironolactone on Renophysiological and Cardiovascular Variables
A study testing Spironolactone and Amiloride in people with Essential Hypertension, run by Regional Hospital Holstebro at 1 site in Denmark.
Trial summary
The investigators wish to study the effect of retaining potassium. The participants have essential hypertension. The test substances are Amiloride, Spironolactone and placebo. The participants will ingest tablets for 28 days before being examined. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- Spironolactone and Amiloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2010to 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hypertension,
- BMI 18,5-30,
- non-smoker
Who cannot join
- Smoking
- Not using contraceptives
- Other illnesses
- Drug or alcohol abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Amiloride and Spironolactone on Renovascular and Cardiovascular Variables in Patients With Essential Hypertension in a Doubleblinded, Randomized, Placebo-controlled, Crossover Study.
The investigators wish to study the effect of retaining potassium. The participants have essential hypertension. The test substances are Amiloride, Spironolactone and placebo. The participants will ingest tablets for 28 days before being examined. We will perform a 24 hours urine collection, 24-hours bloodpressure measurement, blood and urine samples and we also examine the patient using a SphygmoCor.
Read the detailed description
Purpose of the study is to examine the effect of amiloride and spironolactone on
- Renal function (GFR, u-AQP2, u-ENaCβ, u-cAMP, u-PGE2, CH20, FENa, FEK),
- Pulsewave velocity, augmentation index central bloodpressure,
- Vasoactive hormones (PRC, AngII, Aldo, AVP, ANP, BNP and Endot), and
- Ambulatory bloodpressure
- Conditions
- Essential Hypertension
- Being tested
- Spironolactone, Placebo, Amiloride
- Keywords
- Blood pressure, PWV, HRV, PWV, potassium
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpironolactoneDrug
1 tablet twice a day for 28 days
PlaceboOther
1 tablet twice a day for 28 days
AmilorideDrug
1 tablet twice a day for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Amiloride | Active comparator | Not described Receives: Drug: Amiloride |
| Spironolactone | Active comparator | Not described Receives: Drug: Spironolactone |
| Placebo | Placebo comparator | 1 tablet twice a day for 28 days Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bloodpressure
Measured: 24-hours and examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2010 (estimated)
- Study startAug 2010
- Primary completionAug 2015
- Study completionAug 2015
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regional Hospital Holstebro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erling Bjerregaard Pedersen, Regional Hospital Holstebro
- Investigators
- Solveig K Matthesen, MD, Principal investigator, Departments of medical research and medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01195805
- Sponsor's protocol ID
- MED.RES.HOS.2010.03.SKM
- Acronym
- hass
- Status last verified
- Mar 2013
- First submitted
- 3 Sep 2010
- Last updated
- 20 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Amiloride and Spironolactone on Renovascular and Cardiovascular Variables in Patients With Essential Hypertension in a Doubleblinded, Randomized, Placebo-controlled, Crossover Study.
- ClinicalTrials.gov ID
- NCT01195805
- Acronym / sponsor ID
- hass / MED.RES.HOS.2010.03.SKM
- Conditions
- Essential Hypertension
- Keywords
- Blood pressure, PWV, HRV, PWV, potassium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Regional Hospital HolstebroUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 6 Sep 2010 (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.
The investigators wish to study the effect of retaining potassium. The participants have essential hypertension. The test substances are Amiloride, Spironolactone and placebo. The participants will ingest tablets for 28 days before being examined. We will perform a 24 hours urine collection, 24-hours bloodpressure measurement, blood and urine samples and we also examine the patient using a SphygmoCor.
Detailed description
Purpose of the study is to examine the effect of amiloride and spironolactone on
- Renal function (GFR, u-AQP2, u-ENaCβ, u-cAMP, u-PGE2, CH20, FENa, FEK),
- Pulsewave velocity, augmentation index central bloodpressure,
- Vasoactive hormones (PRC, AngII, Aldo, AVP, ANP, BNP and Endot), and
- Ambulatory bloodpressure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Amiloride | Active comparator | Drug: Amiloride |
| Spironolactone | Active comparator | Drug: Spironolactone |
| Placebo | Placebo comparator | Other: Placebo1 tablet twice a day for 28 days |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- hypertension,
- BMI 18,5-30,
- non-smoker
Key exclusion criteria (4 listed)
- Smoking
- Not using contraceptives
- Other illnesses
- Drug or alcohol abuse
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 |
|---|---|---|
| Spironolactone1 tablet twice a day for 28 days | Drug | Spironolactone |
| Placebo1 tablet twice a day for 28 days | Other | Placebo |
| Amiloride1 tablet twice a day for 28 days | Drug | Amiloride |
Primary outcome
Bloodpressure
Time frame: 24-hours and examination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2015.
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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.
Solveig K Matthesen, MD principal investigator
Departments of medical research and medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spironolactone and Amiloride 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 4 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: finished, as of the sponsor's last update on 20 Aug 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bloodpressure (time frame: 24-hours and examination). 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 20 Aug 2015.