CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 110 enrolled
Drug / intervention
Isosorbide Mononitrate +1 moredrug
Likely dose
Isosorbide Mononitrate 30 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02053493
NCT02053493Phase 2Completed
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Nitrate's Effect on Activity Tolerance in Heart Failure With Preserved Ejection Fraction

Adrian Hernandez·interventional·Posted Feb 3, 2014·Updated Nov 28, 2016

In Brief

A Phase 2 clinical trial evaluating Isosorbide Mononitrate and Placebo for Heart Failure. Completed, enrolled 110 participants across 22 sites.

Detailed Summary

A randomized, double-blinded, placebo-controlled crossover study to assess effect of isosorbide mononitrate with dose up-titration on activity tolerance as assessed by (hip-worn, tri-axial) accelerometry.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI), Mayo Clinic, University of Vermont

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 3, 2014
Enrollment StartApr 1, 2014
Primary CompletionFeb 1, 2015
Study CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 12.4 years ago

Interventions

Isosorbide Mononitratedrug

Dispense phase 1 study drug: Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN Dispense phase-2 study drug: Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN

Placebodrug

Dispense phase 1 study drug: Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo Dispense phase-2 study drug: Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo