HypertensionNCT01743911
Tadalafil Effects in Left Ventricle Diastolic Dysfunction in Resistant Hypertensive Patients
A study testing sugar pill and Tadalafil in people with Hypertension, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
Left ventricle diastolic dysfunction (LVDD) is associated with resistant hypertension. In addition, brain natriuretic peptide (BNP) levels are elevated when LVDD is present. It has been shown that phosphodiesterase-5 (PDE5) inhibition improves left ventricle diastolic function in hypertensive rats, despite any… Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- sugar pill and Tadalafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2010to Aug 2012
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- resistant hypertension (according to Resistant Hypertension - American Heart Association Statement - 2008);
- compliance with antihypertensive treatment;
- age >35 years;
- left ventricle diastolic dysfunction types I and II
Who cannot join
- valvulopathy
- decompensated heart failure
- important cardiac arrhythmias
- nephropathy
- hepatopathy
- autoimmune disease
Show all 9Show fewer
- tabagism
- decompensated diabetes
- uncontrolled dislipidemia
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Laboratory of Cardiovascular Pharmacology - FCM - Unicamp
Campinas, São Paulo, 13083-970
About this study
Official title: Phosphodiesterase-5 Inhibitor (Tadalafil) Two Weeks Administration Period Effects in Left Ventricle Diastolic Dysfunction and BNP Levels in Resistant Hypertensive Patients
Left ventricle diastolic dysfunction (LVDD) is associated with resistant hypertension. In addition, brain natriuretic peptide (BNP) levels are elevated when LVDD is present. It has been shown that phosphodiesterase-5 (PDE5) inhibition improves left ventricle diastolic function in hypertensive rats, despite any difference in blood pressure levels. Also, left ventricle diastolic function enhancement reduces BNP concentration in hypertensive patients. However, it is unknown if these effects exists in humans with resistant hypertension. Therefore, this study was developed to evaluate if the use of a PDE5 inhibitor (tadalafil) for 2 weeks improves LVDD and its effects in BNP levels in resistant hypertensive patients.
Read the detailed description
Resistant hypertensive patients have a high incidence of left ventricle diastolic dysfunction (LVDD). Lowering blood pressure levels improves diastolic function, however, there is no proved effective treatment specifically for this disease. Studies in hypertensive rats have shown presence of phosphodiesterase-5 in cardiac cells and an improvement in left ventricle diastolic function using a phosphodiesterase-5 (PDE5) inhibitor, the sildenafil. PDE5 has also been demonstrated in human heart cells with cardiac disease. In addition, LVDD is associated with high levels of brain natriuretic peptide (BNP), which reduces with diastolic function improvement. Therefore, it is reasonable to suppose that PDE-5 inhibitor use in humans with LVDD and resistant hypertension could improve diastolic function. Objective: Evaluate the chronic effect of a PDE-5 inhibitor on LVDD and BNP levels in resistant hypertensive patients. Casuistic and methods: 20 resistant hypertensive patients with LVDD types I and II will be evaluated with echocardiography study, ambulatory blood pressure monitoring (ABPM), office blood pressure measurements, endothelial function analysis using the brachial artery flow mediation dilation technique (FMD) and BNP plasma levels. Then, the subjects will receive oral placebo for 2 weeks. After this period, the same exams will be repeated. Two weeks later, the protocol will be performed again to the same 20 patients, using tadalafil (the longest half-life PDE-5 inhibitor) 20mg orally instead of the placebo. Hypothesis: investigators hypothesize that the use of tadalafil will improve left ventricle diastolic function with BNP reduced levels and this effect will be independent of blood pressure decrease or endothelial function improvement.
- Conditions
- Hypertension
- Being tested
- sugar pill, Tadalafil
- Keywords
- Tadalafil, Resistant Hypertension, Left Ventricle Diastolic Dysfunction, Brain natriuretic peptide
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sugar pillOther
Also called No brand name.
Sugar pills: 20mg orally, once a day for 2 weeks
TadalafilDrug
Also called Cialis, Lilly, USA
Tadalafil pills: 20mg orally, once a day for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| sugar pill | Placebo comparator | Intervention: sugar pill Receives: Other: sugar pill |
| tadalafil | Active comparator | Intervention: tadalafil Receives: Drug: Tadalafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Left Ventricle Diastolic Dysfunction
Outcome measurement assessed by Echocardiogram before and after a 2-week tadalafil administration period.
Measured: Baseline and 2 weeks
Secondary outcomes (5)
Change in endothelial function
Outcome measure assessed by flow-mediated dilation before and after a 2-week tadalafil administration period.
Measured: baseline and 2 weeks
Change in blood pressure levels
Blood pressure measurements assessed before and after a 2-week tadalafil administration period.
Measured: Baseline and 2 weeks
Change in B-type Natriuretic Peptide (BNP-32) levels
Plasma brain natriuretic peptide (BNP-32)assessed before and after a 2-week tadalafil administration period
Measured: Baseline and 2 weeks
Change in cyclic guanosine monophosphate (cGMP) levels
Cyclic guanosine monophosphate (cGMP) levels assessed before and after a 2-week tadalafil administration period
Measured: Baseline and 2 weeks
Change in nitrite levels
Nitrite levels assessed before and after a 2-week tadalafil administration period.
Measured: Baseline and 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startSep 2010
- Primary completionApr 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Heitor Moreno Junior, University of Campinas, Brazil
- Investigators
- Heitor Moreno-Junior, MD, PhD, Principal investigator, Faculty of Medical Sciences - Unicamp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01743911
- Sponsor's protocol ID
- CAAE 0044.0.146.000-09
- Other IDs
- [2009/53430-7], 2009
- Status last verified
- Dec 2012
- First submitted
- 30 Nov 2012
- Last updated
- 6 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phosphodiesterase-5 Inhibitor (Tadalafil) Two Weeks Administration Period Effects in Left Ventricle Diastolic Dysfunction and BNP Levels in Resistant Hypertensive Patients
- ClinicalTrials.gov ID
- NCT01743911
- Acronym / sponsor ID
- CAAE 0044.0.146.000-09
- Conditions
- Hypertension
- Keywords
- Tadalafil, Resistant Hypertension, Left Ventricle Diastolic Dysfunction, Brain natriuretic peptide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Sep 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 6 Dec 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.
Left ventricle diastolic dysfunction (LVDD) is associated with resistant hypertension. In addition, brain natriuretic peptide (BNP) levels are elevated when LVDD is present. It has been shown that phosphodiesterase-5 (PDE5) inhibition improves left ventricle diastolic function in hypertensive rats, despite any difference in blood pressure levels. Also, left ventricle diastolic function enhancement reduces BNP concentration in hypertensive patients. However, it is unknown if these effects exists in humans with resistant hypertension. Therefore, this study was developed to evaluate if the use of a PDE5 inhibitor (tadalafil) for 2 weeks improves LVDD and its effects in BNP levels in resistant hypertensive patients.
Detailed description
Resistant hypertensive patients have a high incidence of left ventricle diastolic dysfunction (LVDD). Lowering blood pressure levels improves diastolic function, however, there is no proved effective treatment specifically for this disease. Studies in hypertensive rats have shown presence of phosphodiesterase-5 in cardiac cells and an improvement in left ventricle diastolic function using a phosphodiesterase-5 (PDE5) inhibitor, the sildenafil. PDE5 has also been demonstrated in human heart cells with cardiac disease. In addition, LVDD is associated with high levels of brain natriuretic peptide (BNP), which reduces with diastolic function improvement. Therefore, it is reasonable to suppose that PDE-5 inhibitor use in humans with LVDD and resistant hypertension could improve diastolic function. Objective: Evaluate the chronic effect of a PDE-5 inhibitor on LVDD and BNP levels in resistant hypertensive patients. Casuistic and methods: 20 resistant hypertensive patients with LVDD types I and II will be evaluated with echocardiography study, ambulatory blood pressure monitoring (ABPM), office blood pressure measurements, endothelial function analysis using the brachial artery flow mediation dilation technique (FMD) and BNP plasma levels. Then, the subjects will receive oral placebo for 2 weeks. After this period, the same exams will be repeated. Two weeks later, the protocol will be performed again to the same 20 patients, using tadalafil (the longest half-life PDE-5 inhibitor) 20mg orally instead of the placebo. Hypothesis: investigators hypothesize that the use of tadalafil will improve left ventricle diastolic function with BNP reduced levels and this effect will be independent of blood pressure decrease or endothelial function improvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sugar pill | Placebo comparator | Other: sugar pillIntervention: sugar pill |
| tadalafil | Active comparator | Drug: TadalafilIntervention: tadalafil |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- resistant hypertension (according to Resistant Hypertension - American Heart Association Statement - 2008);
- compliance with antihypertensive treatment;
- age >35 years;
- left ventricle diastolic dysfunction types I and II
Key exclusion criteria (9 listed)
- valvulopathy
- decompensated heart failure
- important cardiac arrhythmias
- nephropathy
- hepatopathy
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 |
|---|---|---|
| sugar pillAlso: No brand name.Sugar pills: 20mg orally, once a day for 2 weeks | Other | sugar pill |
| TadalafilAlso: Cialis, Lilly, USATadalafil pills: 20mg orally, once a day for 2 weeks. | Drug | tadalafil |
Primary outcome
Change in Left Ventricle Diastolic Dysfunction
Time frame: Baseline and 2 weeks
Outcome measurement assessed by Echocardiogram before and after a 2-week tadalafil administration period.
5 secondary outcomes
Change in endothelial function
Time frame: baseline and 2 weeks
Change in blood pressure levels
Time frame: Baseline and 2 weeks
Change in B-type Natriuretic Peptide (BNP-32) levels
Time frame: Baseline and 2 weeks
Change in cyclic guanosine monophosphate (cGMP) levels
Time frame: Baseline and 2 weeks
Change in nitrite levels
Time frame: Baseline and 2 weeks
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 6 Dec 2012.
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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.
Heitor Moreno-Junior, MD, PhD principal investigator
Faculty of Medical Sciences - Unicamp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sugar pill and Tadalafil in people with Hypertension, run by University of Campinas, Brazil 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 9 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 6 Dec 2012. 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. 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?
Change in Left Ventricle Diastolic Dysfunction (time frame: Baseline and 2 weeks). 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 6 Dec 2012.