Phase 4
Completed N=21
A 48-week Study of the Effect of Dual Therapy (Inhaled Treprostinil and Tadafafil) Versus Monotherapy (Tadalafil).
Hypertension, Pulmonary
Source: ClinicalTrials.gov NCT01305252 ↗
Enrolled (actual)
21
Serious AEs
4.8%
Results posted
Jun 2017
Primary outcomePrimary: Change in Right Ventricular Ejection Fraction — 7.45; 2.8 percent change — p=0.03
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The Study Hypothesis:
Aggressive, upfront, dual therapy for treatment-naïve NYHA I/II/III PAH is superior to a traditional "step-up" approach.
The study will evaluate:
1. Impact of dual, upfront, therapy on cardiovascular parameters in PAH as gauged by cardiac magnetic resonance imaging (cMRI) at 24 weeks and event free survival at outcome at 48 weeks.
2. Value of novel biomarkers (NT-pro BNP, Mts1/S100A4, and insulin resistance) and cutting-edge imaging technologies (cardiac MRI) as newer endpoints for clinical trials in PAH.
3. Utility of longer clinical trial design with the use of combined clinical events as time to clinical worsening surrogate
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Right Ventricular Ejection Fraction |
7.45; 2.8 | 0.03 sig |
| SECONDARY 6 Minute Walk Distance |
82.63; 87.69 | — |
| SECONDARY N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) |
1239; 988.4 | — |
| SECONDARY Change in NYHA/WHO Class |
6; 11 | 0.03 sig |
| SECONDARY B-type Natriuretic Peptide (BNP) |
374; 295.6 | — |
Eligibility Criteria
Inclusion criteria
- Age 18 and 5 years, portopulmonary disease, and human immunodeficiency virus (HIV) infection not on protease inhibitor).
- PAH treatment naïve including any prostacycline, endothelin receptor antagonist, or phosphodiesterase inhibitors within 12 months prior to enrollment.
- Previous Right Heart Catheterization that documented:
- Mean PAP; 25 mmHg.
- Pulmonary capillary wedge pressure 160 mm or DBP > 100mm
- Severe hypotension: SBP < 80 mmHg.
- Pregnant or breast-feeding
- Psychiatric, addictive, or other disorder that compromises patient's ability to provide informed consent, follow study protocol, and adhere to treatment instructions
- Co-morbid conditions that would impair a patient's exercise performance and ability to assess WHO functional class, including but not limited to chronic low-back pain or peripheral musculoskeletal problems.
- Contraindications for magnetic resonance imaging, including significant claustrophobia, implanted metallic objects, or others as per Appendix X).
- Known allergy to treprostinil or tadalafil.
- Active oral nitrate use.
- Diabetes mellitus.
- Planned initiation of cardiac or pulmonary rehabilitation during period of study.
Data sourced from ClinicalTrials.gov (NCT01305252). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.