Trial Outcomes & Findings for Pre-clinical Cardiac Dysfunction Among Asymptomatic Hypertensive Patients (NCT NCT00689819)
NCT ID: NCT00689819
Last Updated: 2013-12-03
Results Overview
To evaluate the ability of this program to produce (as a surrogate for heart failure prevention) a clinically significant difference in blood pressure lowering, health status and quality of life between the 2 treatment groups.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
123 participants
Primary outcome timeframe
Baseline and 1 year
Results posted on
2013-12-03
Participant Flow
Participant milestones
| Measure |
Treatment 1
This arm will target a blood pressure of \< 140/90 mmHg (or \< 130/90 mmHg for diabetics or those with chronic kidney disease) as indicated by the 7th Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure.
|
Treatment 2
This arm will target a more aggressive blood pressure target of \< 120/80 mmHg.
|
|---|---|---|
|
Overall Study
STARTED
|
65
|
58
|
|
Overall Study
COMPLETED
|
45
|
43
|
|
Overall Study
NOT COMPLETED
|
20
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pre-clinical Cardiac Dysfunction Among Asymptomatic Hypertensive Patients
Baseline characteristics by cohort
| Measure |
Treatment 1
n=65 Participants
This arm will target a blood pressure of \< 140/90 mmHg (or \< 130/90 mmHg for diabetics or those with chronic kidney disease) as indicated by the 7th Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure.
|
Treatment 2
n=58 Participants
This arm will target a more aggressive blood pressure target of \< 120/80 mmHg.
|
Total
n=123 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
65 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
49.3 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
49.6 years
STANDARD_DEVIATION 8.3 • n=7 Participants
|
49.4 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
65 participants
n=5 Participants
|
58 participants
n=7 Participants
|
123 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 1 yearTo evaluate the ability of this program to produce (as a surrogate for heart failure prevention) a clinically significant difference in blood pressure lowering, health status and quality of life between the 2 treatment groups.
Outcome measures
| Measure |
Treatment 1
n=45 Participants
This arm will target a blood pressure of \< 140/90 mmHg (or \< 130/90 mmHg for diabetics or those with chronic kidney disease) as indicated by the 7th Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure.
|
Treatment 2
n=43 Participants
This arm will target a more aggressive blood pressure target of \< 120/80 mmHg.
|
|---|---|---|
|
Clinically Significant Difference in Blood Pressure Lowering, Health Status and Quality of Life
|
-3.3 mm Hg
Interval -7.6 to 2.1
|
-4.9 mm Hg
Interval -11.7 to 1.9
|
SECONDARY outcome
Timeframe: Baseline and 1 yearTo measure the change from baseline to 1 year prevalence of pre-clinical cardiac dysfunction in randomized study patients.
Outcome measures
| Measure |
Treatment 1
n=45 Participants
This arm will target a blood pressure of \< 140/90 mmHg (or \< 130/90 mmHg for diabetics or those with chronic kidney disease) as indicated by the 7th Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure.
|
Treatment 2
n=43 Participants
This arm will target a more aggressive blood pressure target of \< 120/80 mmHg.
|
|---|---|---|
|
Change in Prevalence of PCCD
|
91.8 percentage of participants
|
88.7 percentage of participants
|
Adverse Events
Treatment 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place