Effects of Aliskiren on Patient With Heart Failure and a Normal Ejection Fraction (Aliskiren)
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|ClinicalTrials.gov Identifier: NCT00982033|
Recruitment Status : Completed
First Posted : September 22, 2009
Results First Posted : March 22, 2017
Last Update Posted : February 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Drug: aliskiren Drug: placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Blinded, Placebo-Controlled Six Month Treatment Trial of Aliskiren to Improve Exercise Tolerance in Older Patients With Heart Failure and Normal Ejection Fraction|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||December 2011|
Active Comparator: Aliskiren
50 % of subjects participating in this trial will be on the active medication, Aliskiren 300mg qd, the other 50% will be on placebo.
aliskiren 300mg qd versus placebo for 24 weeks.
Other Name: Tekturna
Placebo Comparator: Placebo
50% of subjects will be randomized to placebo.
placebo qd for 24 weeks
- Exercise Treadmill Time [ Time Frame: Baseline, 24 week visit ]
Treadmill exercise time to exhaustion on the modified naughton protocol.
LS-mean is in effect, within-group means appropriately adjusted for the other effects in the model.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00982033
|United States, North Carolina|
|Wake Forest University Health Sciences|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Dalane W Kitzman, MD||Wake Forest University Health Sciences|