Heart FailurePhase 4NCT00793338
Evaluation of Sildenafil for the Treatment of Moderate Congestive Heart Failure
A Phase 4 study testing Sildenafil in people with Heart Failure, run by University of New Mexico at 1 site in United States.
Trial summary
The purpose of the study is to evaluate whether sildenafil helps treat heart failure. Some patients with heart failure have high blood pressure in the lungs (referred to as "pulmonary hypertension"). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Sildenafil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Feb 2011
- Phase
- Phase 4
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 18 years
- Diagnosis of chronic heart failure with an ejection fraction less than or equal to 45% per either an echocardiogram, nuclear cardiolyte stress test, or cardiac catheterization performed within the past 6 months.
- New York Heart Association Functional Class III
- Must be on optimal heart failure therapy according to AHA/ACC heart failure guidelines, including treatment with ACEI and beta-blocker therapy, or have documented rationale for variation, including intolerance, contraindication, patient preference, or personal physician's judgment
Who cannot join
- Comorbid disease or behavioral or other limitations that: 1) interfere with performing exercise test, or 2) prevent completion of 12 week study
- Currently pregnant or intent to become pregnant in the next 12 weeks or currently breastfeeding.
- Major cardiovascular event or cardiovascular procedure within the prior 6 weeks
- History of Chronic Obstructive Pulmonary Disease or Reactive Airway Disease
- Known hypersensitivity to sildenafil
- Current use of medications known to be a potent inhibitor of CYP3A4 (e.g., ritonavir, ketoconazole, itraconazole)
- Current or recent (within 6 months) use of organic nitrate medications (e.g. isosorbide dinitrate, sublingual nitroglycerin)
- Known diagnosis of pulmonary veno-occlusive disease or non-arteritic anterior ischemic optic neuropathy
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Translational Science Center
Albuquerque, New Mexico, 87131
About this study
The purpose of the study is to evaluate whether sildenafil helps treat heart failure. Some patients with heart failure have high blood pressure in the lungs (referred to as "pulmonary hypertension"). Sildenafil is a medication that is used to treat high blood pressure in the lungs and may reduce symptoms of heart failure. Studies have looked at the short-term benefit of sildenafil in patients with congestive heart failure, but this study will look at the longer-term benefits of 12 weeks of therapy with sildenafil.
Read the detailed description
Objective: To determine the effect of acute and long-term treatment with sildenafil on the clinical status of patients with moderate HF. Secondary Objectives: To determine the effect of acute and long-term treatment with sildenafil on cardiopulmonary exercise performance, the effect of acute and long-term treatment with sildenafil on neurohormonal activation, the effect of acute and long-term treatment with sildenafil on hemodynamics, and the effect of long-term treatment with sildenafil on quality of life. Background: Secondary pulmonary hypertension (PH) is a frequent manifestation of heart failure resulting in impaired vascular reactivity and permeability which contributes to the symptoms of HF. Levels of endothelin-1 (ET-1), a potent vasoconstrictor, are increased in patients with HF. At the same time, pulmonary artery nitric oxide (NO) production is decreased. NO increases concentrations of the second messenger cyclic-GMP, ultimately leading to vasodilation. This imbalance between NO-dependent vasodilation and ET-1 induced vasoconstriction likely contributes to the development of secondary pulmonary hypertension. cGMP is metabolized by the type 5 isoform of phosphodiesterase (PDE5) an enzyme that is highly expressed in the lung. Sildenafil, a selective PDE5 inhibitor, has been used extensively for the treatment of erectile dysfunction and has recently been approved for use in the treatment of PH. Recent studies of short-term administration of sildenafil in HF patients with secondary PH have demonstrated reductions in pulmonary arterial pressure, pulmonary vascular resistance, pulmonary capillary wedge pressure, and systemic vascular resistance while increasing cardiac index and exercise performance. However, it remains to be seen if sildenafil is safe and effective in the long-term treatment of heart failure. Methods: This will be an open-label, pilot study designed to evaluate the safety and efficacy of sildenafil for the treatment of moderate heart failure. The primary endpoint will be change in 6-minute walk test distance. Secondary endpoints will be changes in peak oxygen consumption (measured by cardiopulmonary exercise testing), neurohormones (b-type natriuretic peptide, catecholamines, ET-1), quality of life scores. Additionally, we will attempt to analyze responsiveness to sildenafil on the basis of PDE5 polymorphisms. Study procedures will be performed at the UNM General Clinical Research Center and the UNM Congestive Heart Failure Clinic. Patients will be hospitalized for 3 days to analyze safety and efficacy of sildenafil administered three times daily. Patients will complete exercise testing, neurohormone, and hemodynamic assessments at baseline (day 1) and following 24 hours of sildenafil treatment. The patients will then be discharged to complete a 12-week maintenance phase of treatment. At the conclusion of the maintenance phase the patients will be readmitted for 2 day to have repeat measurements performed. The main analysis will be done using paired t-tests. All statistical analysis will be performed using SAS v6.12.
- Conditions
- Heart Failure
- Being tested
- Sildenafil
- Keywords
- Heart failure, Sildenafil, Cardiopulmonary exercise test, quality of life, 6 minute walk test
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SildenafilDrug
Also called Heart failure, Cardiopulmonary exercise test
Sildenafil 20mg three times a day for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Sildenafil | Experimental | All patients will receive open-label treatment with sildenafil. Receives: Drug: Sildenafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 6-minute walk distance
Measured: 24 hours and 3 months
Secondary outcomes (3)
Changes in peak oxygen consumption (measured by cardiopulmonary exercise testing)
Measured: 24 hours and 3 months
Change in the level of neurohormones (b-type natriuretic peptide, catecholamines, ET-1),
Measured: 24 hours and 3 months
Change in quality of life
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionNov 2010 (estimated)
- Study completionFeb 2011 (estimated)
Why it stopped: The project was not funded and could not be initiated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joe R. Anderson, University of New Mexico
- Investigators
- Joe R Anderson, PharmD, Principal investigator, University of New Mexico College of Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00793338
- Sponsor's protocol ID
- HRRC 05-369
- Status last verified
- Jun 2023
- First submitted
- 17 Nov 2008
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Sildenafil for the Treatment of Moderate Congestive Heart Failure
- ClinicalTrials.gov ID
- NCT00793338
- Acronym / sponsor ID
- HRRC 05-369
- Conditions
- Heart Failure
- Keywords
- Heart failure, Sildenafil, Cardiopulmonary exercise test, quality of life, 6 minute walk test
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The project was not funded and could not be initiated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Nov 2010 (estimated)
- Study completion
- Feb 2011 (estimated)
- First posted
- 19 Nov 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.
The purpose of the study is to evaluate whether sildenafil helps treat heart failure. Some patients with heart failure have high blood pressure in the lungs (referred to as "pulmonary hypertension"). Sildenafil is a medication that is used to treat high blood pressure in the lungs and may reduce symptoms of heart failure. Studies have looked at the short-term benefit of sildenafil in patients with congestive heart failure, but this study will look at the longer-term benefits of 12 weeks of therapy with sildenafil.
Detailed description
Objective: To determine the effect of acute and long-term treatment with sildenafil on the clinical status of patients with moderate HF. Secondary Objectives: To determine the effect of acute and long-term treatment with sildenafil on cardiopulmonary exercise performance, the effect of acute and long-term treatment with sildenafil on neurohormonal activation, the effect of acute and long-term treatment with sildenafil on hemodynamics, and the effect of long-term treatment with sildenafil on quality of life. Background: Secondary pulmonary hypertension (PH) is a frequent manifestation of heart failure resulting in impaired vascular reactivity and permeability which contributes to the symptoms of HF. Levels of endothelin-1 (ET-1), a potent vasoconstrictor, are increased in patients with HF. At the same time, pulmonary artery nitric oxide (NO) production is decreased. NO increases concentrations of the second messenger cyclic-GMP, ultimately leading to vasodilation. This imbalance between NO-dependent vasodilation and ET-1 induced vasoconstriction likely contributes to the development of secondary pulmonary hypertension. cGMP is metabolized by the type 5 isoform of phosphodiesterase (PDE5) an enzyme that is highly expressed in the lung. Sildenafil, a selective PDE5 inhibitor, has been used extensively for the treatment of erectile dysfunction and has recently been approved for use in the treatment of PH. Recent studies of short-term administration of sildenafil in HF patients with secondary PH have demonstrated reductions in pulmonary arterial pressure, pulmonary vascular resistance, pulmonary capillary wedge pressure, and systemic vascular resistance while increasing cardiac index and exercise performance. However, it remains to be seen if sildenafil is safe and effective in the long-term treatment of heart failure. Methods: This will be an open-label, pilot study designed to evaluate the safety and efficacy of sildenafil for the treatment of moderate heart failure. The primary endpoint will be change in 6-minute walk test distance. Secondary endpoints will be changes in peak oxygen consumption (measured by cardiopulmonary exercise testing), neurohormones (b-type natriuretic peptide, catecholamines, ET-1), quality of life scores. Additionally, we will attempt to analyze responsiveness to sildenafil on the basis of PDE5 polymorphisms. Study procedures will be performed at the UNM General Clinical Research Center and the UNM Congestive Heart Failure Clinic. Patients will be hospitalized for 3 days to analyze safety and efficacy of sildenafil administered three times daily. Patients will complete exercise testing, neurohormone, and hemodynamic assessments at baseline (day 1) and following 24 hours of sildenafil treatment. The patients will then be discharged to complete a 12-week maintenance phase of treatment. At the conclusion of the maintenance phase the patients will be readmitted for 2 day to have repeat measurements performed. The main analysis will be done using paired t-tests. All statistical analysis will be performed using SAS v6.12.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sildenafil | Experimental | Drug: SildenafilAll patients will receive open-label treatment with sildenafil. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age greater than 18 years
- Diagnosis of chronic heart failure with an ejection fraction less than or equal to 45% per either an echocardiogram, nuclear cardiolyte stress test, or cardiac catheterization performed within the past 6 months.
- New York Heart Association Functional Class III
- Must be on optimal heart failure therapy according to AHA/ACC heart failure guidelines, including treatment with ACEI and beta-blocker therapy, or have documented rationale for variation, including intolerance, contraindication, patient preference, or personal physician's judgment
Key exclusion criteria (8 listed)
- Comorbid disease or behavioral or other limitations that: 1) interfere with performing exercise test, or 2) prevent completion of 12 week study
- Currently pregnant or intent to become pregnant in the next 12 weeks or currently breastfeeding.
- Major cardiovascular event or cardiovascular procedure within the prior 6 weeks
- History of Chronic Obstructive Pulmonary Disease or Reactive Airway Disease
- Known hypersensitivity to sildenafil
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 |
|---|---|---|
| SildenafilAlso: Heart failure, Cardiopulmonary exercise testSildenafil 20mg three times a day for 3 months. | Drug | Sildenafil |
Primary outcome
Change in 6-minute walk distance
Time frame: 24 hours and 3 months
3 secondary outcomes
Changes in peak oxygen consumption (measured by cardiopulmonary exercise testing)
Time frame: 24 hours and 3 months
Change in the level of neurohormones (b-type natriuretic peptide, catecholamines, ET-1),
Time frame: 24 hours and 3 months
Change in quality of life
Time frame: 3 months
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 26 Jun 2023.
- Individual participant dataSharing planned: Undecided
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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.
Joe R Anderson, PharmD principal investigator
University of New Mexico College of Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sildenafil in people with Heart Failure, run by University of New Mexico 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 4 inclusion and 8 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 26 Jun 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in 6-minute walk distance (time frame: 24 hours and 3 months). 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 26 Jun 2023.