Diastolic Heart FailureARID-HFNCT00773084
Aliskiren and Renin Inhibition in Diastolic Heart Failure
A study testing Aliskiren plus spironolactone vs. Lisinopril plus spironolactone in people with Diastolic Heart Failure, run by Texas Tech University Health Sciences Center at 1 site in United States.
Trial summary
This study is being conducted to compare the effects that 2 different combinations of heart failure medications have on the levels of certain blood markers which cause and/or worsen heart failure. Additionally, the investigators will investigate any differences that may exist between Hispanics and Non-Hispanics. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Diastolic Heart Failure
- What is being tested?
- Aliskiren plus spironolactone vs. Lisinopril plus spironolactone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Aug 2009
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic stable diastolic HF documented by clinical diagnosis and echocardiogram within the last 2 years
- NYHA classes I-III, symptomatically stable (for >1month)
- Age 21-70 years
- Either of Hispanic ethnicity (Mexican American origin) or non-Hispanic white
- Patients on ACE inhibitor therapy (lisinopril)
- Blood pressure >100/75 mmHg
- Adequate birth control
- Patients seen in TTUHSC Cardiology or Internal Medicine clinic for at least two visits since January 2008
Who cannot join
- Acute coronary syndrome (within the last month).
- Recent acute diastolic or systolic HF (within the last month)
- Pancreatic disease
- Renal artery stenosis
- Pregnancy
- History of angioedema
Show all 11Show fewer
- Severe hypotension (systolic BP<90mmHg or mean arterial pressure <65mmHg)
- Hyperkalemia (defined by K+>5 mEq/L)
- Chronic Kidney Disease (Stage 3 and above)
- Systolic dysfunction (ejection fraction below 50%)
- Ethnicity other than Mexican American or non-Hispanic white
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430
About this study
Official title: Aliskiren and Renin Inhibition in Diastolic Heart Failure in Mexican Americans
This study is being conducted to compare the effects that 2 different combinations of heart failure medications have on the levels of certain blood markers which cause and/or worsen heart failure. Additionally, the investigators will investigate any differences that may exist between Hispanics and Non-Hispanics. The investigators hope to find that Hispanic Americans will have a greater response to this new regimen compared to non-Hispanic Americans.
Read the detailed description
Our main hypothesis is that in contrast to non Hispanic whites, the degree of RAAS system activation is more pronounced in Mexican Americans with diastolic HF and consequently their response to RAAS inhibition therapy is greater. Blocking the RAAS with renin inhibitor plus aldosterone receptor blocker should produce measurable changes in biomarkers as well as physiologic improvement that could therefore translate into improved clinical outcomes. These changes should be greater appreciated in Mexican Americans if the central pathophysiologic influence of HF in this population was RAAS maladaptation.
- Conditions
- Diastolic Heart Failure
- Being tested
- Aliskiren plus spironolactone vs. Lisinopril plus spironolactone
- Keywords
- Diastolic Heart Failure, Hispanic Americans, Aliskiren, Spironolactone, Lisinopril, Diastolic Heart Failure in Hispanic Americans
- Medical subject headings
- Heart Failure, Diastolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aliskiren plus spironolactone vs. Lisinopril plus spironolactoneDrug
Also called Tekturna, Lisinopril, Spironolactone
Subjects will be in the study for a total of 8 weeks. Subjects with stable diastolic HF on current ACEI therapy will be randomized into two treatment groups. The study group will receive Aliskiren plus spironolactone and the control group will receive Lisinopril plus spironolactone. These 2 groups will be further divided according to ethnicity: Mexican Americans and non-Hispanic whites. Sixty patients will be recruited, 30 per treatment group. Subjects will have a 2 week wash-out period. At the end of this period, blood will be collected and subjects will be asked to take the assigned medication once daily for 6 weeks. Subjects will be asked to return every 2 weeks at which time blood pressure, serum potassium and creatinine levels will be assessed. Their medications will be titrated depending on clinical tolerance and symptom control. At the end of 6 weeks of treatment blood markers will be drawn and differences will be analyzed.
| Study group | Role | What they receive |
|---|---|---|
| Drug | Active comparator | Aliskiren plus spironolactone vs. Lisinopril plus spironolactone Receives: Drug: Aliskiren plus spironolactone vs. Lisinopril plus spironolactone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the baseline level of RAAS dysregulation between Mexican Americans and non-Hispanic whites with stable diastolic HF by measuring established biomarkers.
Measured: 8 weeks
Evaluate the superiority of aliskiren plus spironolactone combination over an lisinopril plus spironolactone combination in inhibiting the RAAS system among patients with diastolic HF.
Measured: 8 weeks
Compare the clinical and biological benefit of RAAS system inhibition between aliskiren plus spironolactone and lisinopril plus spironolactone as measured by clinical indicators and serum biomarkers
Measured: 8 weeks
Assess ethnicity-specific differences in the clinical response to either RAAS inhibition treatment between Mexican Americans and non-Hispanic whites.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionAug 2009 (estimated)
- Study completionAug 2009 (estimated)
Why it stopped: Difficulty in recruiting patients and then the PI left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diastolic 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00773084
- Sponsor's protocol ID
- ARID-HF
- Acronym
- ARID-HF
- Status last verified
- Mar 2011
- First submitted
- 15 Oct 2008
- Last updated
- 12 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aliskiren and Renin Inhibition in Diastolic Heart Failure in Mexican Americans
- ClinicalTrials.gov ID
- NCT00773084
- Acronym / sponsor ID
- ARID-HF / ARID-HF
- Conditions
- Diastolic Heart Failure
- Keywords
- Diastolic Heart Failure, Hispanic Americans, Aliskiren, Spironolactone, Lisinopril, Diastolic Heart Failure in Hispanic Americans
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulty in recruiting patients and then the PI left the institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences CenterUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Aug 2009 (estimated)
- Study completion
- Aug 2009 (estimated)
- First posted
- 16 Oct 2008 (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.
This study is being conducted to compare the effects that 2 different combinations of heart failure medications have on the levels of certain blood markers which cause and/or worsen heart failure. Additionally, the investigators will investigate any differences that may exist between Hispanics and Non-Hispanics. The investigators hope to find that Hispanic Americans will have a greater response to this new regimen compared to non-Hispanic Americans.
Detailed description
Our main hypothesis is that in contrast to non Hispanic whites, the degree of RAAS system activation is more pronounced in Mexican Americans with diastolic HF and consequently their response to RAAS inhibition therapy is greater. Blocking the RAAS with renin inhibitor plus aldosterone receptor blocker should produce measurable changes in biomarkers as well as physiologic improvement that could therefore translate into improved clinical outcomes. These changes should be greater appreciated in Mexican Americans if the central pathophysiologic influence of HF in this population was RAAS maladaptation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drug | Active comparator | Drug: Aliskiren plus spironolactone vs. Lisinopril plus spironolactoneAliskiren plus spironolactone vs. Lisinopril plus spironolactone |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Chronic stable diastolic HF documented by clinical diagnosis and echocardiogram within the last 2 years
- NYHA classes I-III, symptomatically stable (for >1month)
- Age 21-70 years
- Either of Hispanic ethnicity (Mexican American origin) or non-Hispanic white
- Patients on ACE inhibitor therapy (lisinopril)
Key exclusion criteria (11 listed)
- Acute coronary syndrome (within the last month).
- Recent acute diastolic or systolic HF (within the last month)
- Pancreatic disease
- Renal artery stenosis
- Pregnancy
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 |
|---|---|---|
| Aliskiren plus spironolactone vs. Lisinopril plus spironolactoneAlso: Tekturna, Lisinopril, SpironolactoneSubjects will be in the study for a total of 8 weeks. Subjects with stable diastolic HF on current ACEI therapy will be randomized into two treatment groups. The study group will receive Aliskiren plus spironolactone and the control group will receive Lisinopril plus spironolactone. These 2 groups will be further divided according to ethnicity: Mexican Americans and non-Hispanic whites. Sixty patients will be recruited, 30 per treatment group. Subjects will have a 2 week wash-out period. At the end of this period, blood will be collected and subjects will be asked to take the assigned medication once daily for 6 weeks. Subjects will be asked to return every 2 weeks at which time blood pressure, serum potassium and creatinine levels will be assessed. Their medications will be titrated depending on clinical tolerance and symptom control. At the end of 6 weeks of treatment blood markers will be drawn and differences will be analyzed. | Drug | Drug |
Primary outcome
Compare the baseline level of RAAS dysregulation between Mexican Americans and non-Hispanic whites with stable diastolic HF by measuring established biomarkers.
Time frame: 8 weeks
Evaluate the superiority of aliskiren plus spironolactone combination over an lisinopril plus spironolactone combination in inhibiting the RAAS system among patients with diastolic HF.
Time frame: 8 weeks
Compare the clinical and biological benefit of RAAS system inhibition between aliskiren plus spironolactone and lisinopril plus spironolactone as measured by clinical indicators and serum biomarkers
Time frame: 8 weeks
Assess ethnicity-specific differences in the clinical response to either RAAS inhibition treatment between Mexican Americans and non-Hispanic whites.
Time frame: 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aliskiren plus spironolactone vs. Lisinopril plus spironolactone in people with Diastolic Heart Failure, run by Texas Tech University Health Sciences Center at 1 site in United States.
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 8 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: withdrawn, as of the sponsor's last update on 12 May 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Compare the baseline level of RAAS dysregulation between Mexican Americans and non-Hispanic whites with stable diastolic HF by measuring established biomarkers. (time frame: 8 weeks). The study lists 4 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 12 May 2015.