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NCT01275339 · ClinicalTrials.gov registry record · Phase 4
Aortic Stenosis and PhosphodiEsterase Type 5 iNhibition (ASPEN): A Pilot Study
A Phase 4 study, sponsored by Washington University School of Medicine.
- Terminated
- Registry status
- Phase 4
- Development phase
- 10
- Enrollment target
NCT01275339 is a Phase 4 study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 10 participants.
The verdict
NCT01275339, a Phase 4 study, was terminated before completion, sponsored by Washington University School of Medicine.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 10 participants
- Enrollment target
Study Summary
Currently, aortic stenosis (AS) is considered a "surgical disease" with no medical therapy available to improve any clinical outcomes, including symptoms, time to surgery, or long-term survival. Thus far, randomized studies involving statins have not been promising with respect to slowing progressive valve stenosis. Beyond the valve, two common consequences of aortic stenosis are hypertrophic remodeling of the left ventricle (LV) and pulmonary venous hypertension; each of these has been associated with worse heart failure symptoms, increased operative mortality, and worse long-term outcomes. Whether altering LV structural abnormalities, improving LV function, and/or reducing pulmonary artery pressures with medical therapy would improve clinical outcomes in patients with AS has not been tested. Animal models of pressure overload have demonstrated that phosphodiesterase type 5 (PDE5) inhibition influences nitric oxide (NO) - cyclic guanosine monophosphate (cGMP) signaling in the LV and favorably impacts LV structure and function, but this has not been tested in humans with AS. Studies in humans with left-sided heart failure and pulmonary venous hypertension have shown that PDE5 inhibition improves functional capacity and quality of life, but patients with AS were not included in those studies. The investigators hypothesize that PDE5 inhibition with tadalafil will have a favorable impact on LV structure and function as well as pulmonary artery pressures. In this pilot study, the investigators anticipate that short-term administration of tadalafil to patients with AS will be safe and well-tolerated.
Interventions
- DRUG Placebo
- DRUG Tadalafil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2012-12 |
| Est. Completion | 2017-04-14 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01275339
The ClinicalTrials.gov registry entry for NCT01275339 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01275339 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01275339 about?
NCT01275339 is a clinical study titled "Aortic Stenosis and PhosphodiEsterase Type 5 iNhibition (ASPEN): A Pilot Study". Currently, aortic stenosis (AS) is considered a "surgical disease" with no medical therapy available to improve any clinical outcomes, including symptoms, time to surgery, or long-term survival. Thus far, randomized studies involving statins have not been promising with respect to slowing progressiv...
What is the current status of trial NCT01275339?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 10 participants. The study started on 2012-12. Estimated completion is 2017-04-14.
What interventions are being tested in trial NCT01275339?
The interventions under investigation include: Placebo (DRUG), Tadalafil (DRUG).
Who is sponsoring clinical trial NCT01275339?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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