Trial Outcomes & Findings for Estrogen Diastolic Heart Failure (NCT NCT02693002)
NCT ID: NCT02693002
Last Updated: 2018-08-08
Results Overview
Change in diastolic function as assessed by echocardiography from baseline to 12 weeks
TERMINATED
PHASE4
4 participants
Baseline and 12 weeks
2018-08-08
Participant Flow
Participant milestones
| Measure |
Hormone Replacement Therapy
Estradiol/norethindrone acetate 1mg/0.5 mg by mouth oral daily for 12 weeks
Estradiol/Norethindrone acetate: Estradiol/Norethindrone acetate 1mg/0.5 mg
|
Placebo
Inert ingredients by mouth oral daily for 12 weeks
Placebo: inactive ingredient
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
COMPLETED
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Hormone Replacement Therapy
Estradiol/norethindrone acetate 1mg/0.5 mg by mouth oral daily for 12 weeks
Estradiol/Norethindrone acetate: Estradiol/Norethindrone acetate 1mg/0.5 mg
|
Placebo
Inert ingredients by mouth oral daily for 12 weeks
Placebo: inactive ingredient
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Estrogen Diastolic Heart Failure
Baseline characteristics by cohort
| Measure |
Hormone Replacement Therapy
n=2 Participants
Estradiol/norethindrone acetate 1mg/0.5 mg by mouth oral daily for 12 weeks
Estradiol/Norethindrone acetate: Estradiol/Norethindrone acetate 1mg/0.5 mg
|
Placebo
n=2 Participants
Inert ingredients by mouth oral daily for 12 weeks
Placebo: inactive ingredient
|
Total
n=4 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
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksPopulation: Data was not analyzed for this study. The study was terminated as a result of poor enrollment (N=1, Hormone replacement 1; N=2, placebo). Presenting data for such a low number of participants would compromise participant confidentiality.
Change in diastolic function as assessed by echocardiography from baseline to 12 weeks
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Data was not analyzed for this study. The study was terminated as a result of poor enrollment (N=1, Hormone replacement 1; N=2, placebo). Presenting data for such a low number of participants would compromise participant confidentiality.
Change in activity level as assessed by Duke Activity Status Index. The DASI estimates functional capacity through a series of 12 questions related to daily activity. Questions are scored as zero for a "No" answer or awarded a fixed number of points ranging from 1.75-8 for a "Yes" answer. Scores for each question are added, with the maximum score being 58.2 indicating a fully functional individual. Data are presented as the change in Mean score +/- SEM for each group at baseline and 12 weeks.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Data was not analyzed for this study. The study was terminated as a result of poor enrollment (N=1, Hormone replacement 1; N=2, placebo). Presenting data for such a low number of participants would compromise participant confidentiality.
Change in quality of life score as assessed by Utian Quality of Life scale. The UQoLS measures quality of life in four subcategories: Occupational, health, emotional and sexual. Questions are scored on a scale of 1-5 were 1 indicates "Not true of me" and 5 indicates an answer of "mostly true". Scores to the responses are added and evaluated within each subcategory. Higher scores indicate a higher quality of life within each subcategory with a maximum of 35 points for "Occupational", 31 points for "Health", 28 points for "Emotional" and 15 points for "Sexual" for a total of 100 points indicating the highest quality of life score possible. Data will be presented as the change in quality of life Mean +/- SEM over time.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Data was not analyzed for this study. The study was terminated as a result of poor enrollment (N=1, Hormone replacement 1; N=2, placebo). Presenting data for such a low number of participants would compromise participant confidentiality.
Change in B-type natriuretic peptide (BNP) levels will be measure. Participants will have blood drawn via venipuncture and B-type natriuretic peptide will be measured using a quantitative chemiluminescent immunoassay. Data will be presented as the change in B-type natriuretic peptide over time.
Outcome measures
Outcome data not reported
Adverse Events
Hormone Replacement Therapy
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Hormone Replacement Therapy
n=2 participants at risk
Estradiol/norethindrone acetate 1mg/0.5 mg by mouth oral daily for 12 weeks
Estradiol/Norethindrone acetate: Estradiol/Norethindrone acetate 1mg/0.5 mg
|
Placebo
n=2 participants at risk
Inert ingredients by mouth oral daily for 12 weeks
Placebo: inactive ingredient
|
|---|---|---|
|
Reproductive system and breast disorders
Vaginal Bleeding
|
50.0%
1/2 • Number of events 1 • 12 weeks
|
0.00%
0/2 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place