Phase 3
Completed N=104
Clevidipine in the Treatment of Blood Pressure in Patients With Acute Heart Failure (PRONTO)
Source: ClinicalTrials.gov NCT00803634 ↗Enrolled (actual)
104
Serious AEs
21.2%
Results posted
Aug 2014
Primary outcomePrimary: Time to First Achieve Initial Prespecified SBP Target Range and 15% Reduction From Baseline Within First 30 Minutes — 15.0; NA Minutes
Summary
The purpose of this study was to evaluate the efficacy and safety of intravenous (IV) clevidipine as compared with standard of care IV antihypertensive agents for blood pressure (BP) lowering in patients with acute heart failure and elevated BP.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to First Achieve Initial Prespecified SBP Target Range and 15% Reduction From Baseline Within First 30 Minutes |
15.0; NA | — |
| PRIMARY Percentage to First Achieve Initial Prespecified SBP Target Range [≥20 mm Hg and ≤40 mm Hg Apart] and 15% Reduction From Baseline Within First 30 Minutes |
70.5; 36.6 | — |
| SECONDARY Percentage Reaching Prespecified Target Range Without Falling Below Lower Limit of Target Range Within First 30 Minutes |
45.5; 51.2 | — |
| SECONDARY SBP Area Under the Curve (AUC) Outside Prespecified Target Range |
494.96; 966.15 | — |
| SECONDARY Percentage Falling Below Lower Limit of SBP Target Range Within First 30 Minutes |
34.1; 2.4 | — |
| SECONDARY Percentage Falling Below Lower Limit of SBP Target Range at Any Time During Study |
68.2; 70.7 | — |
| SECONDARY Change From Baseline in Dyspnea (Measured By VAS) at Each Time Point |
-18.6; -16.1; -28.8; -22.8; -37.1; -27.9 | — |
| SECONDARY Time to Use Other IV Antihypertensives During the Study Drug Administration |
NA; 5.7 | — |
| SECONDARY Percentage of Patients Who Received Any Alternative IV Antihypertensive Drug at Any Time During Study Drug Treatment |
15.9; 51.2 | — |
| SECONDARY Percentage of Patients With at Least One Episode of SBP < 90 mm Hg During Study Drug Administration (up to 96 Hours) |
5.9; 1.9 | — |
| SECONDARY Number of Patients That Require Intubation During Study Drug Administration up to 96 Hours |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18 years or older
- Presentation consistent with acute heart failure and pulmonary congestion on physical examination as evidenced by rales
- Baseline systolic blood pressure (immediately prior to initiation of study drug) of ≥160 mm Hg
- Dyspnea score (sitting) of at least 5 on a 10 cm visual analog scale (VAS)
- Required IV antihypertensive therapy to lower blood pressure
- Written informed consent
Exclusion Criteria
- Administration of an agent (IV or oral) for the treatment of elevated BP within the previous 2 hours of randomization. (Previous short-acting non-IV nitrates, continuous positive airway pressure (CPAP), and bi-level positive airway pressure (BiPAP) were permitted)
- Chest pain and/or electrocardiogram with ST segment changes consistent with acute coronary syndrome
- Known or suspected aortic dissection
- Acute myocardial infarction within the prior 14 days
- Dialysis-dependant renal failure
- Requirement for immediate endotracheal intubation
- Positive pregnancy test, known pregnancy or breast feeding female
- Intolerance or allergy to calcium channel blockers
- Allergy to soybean oil or egg lecithin
- Known liver failure, cirrhosis or pancreatitis
- Prior directives against advanced life support
- Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment
Data sourced from ClinicalTrials.gov (NCT00803634). 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.