Trial Outcomes & Findings for Study to Determine How Cialis Effects the Renal Function in Response to Volume Expansion in Preclinical Diastolic Cardiomyopathy (Aim3) (NCT NCT02058095)
NCT ID: NCT02058095
Last Updated: 2020-10-28
Results Overview
Change in total urinary sodium excretion as measured by MEq/min
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
22 participants
Primary outcome timeframe
Baseline, 12 weeks
Results posted on
2020-10-28
Participant Flow
Participant milestones
| Measure |
Tadalafil
Subject received Tadalafil daily for a total of 12 weeks
Tadalafil: Tadalafil 5 mg tablet. Daily. Tadalafil dose varies from 5 mg to 20 mg for 12 weeks. If blood pressure is \>95 then subject dismissed from the Clinical Research Unit (CRU) on 2 (5 mg) tabs of tadalafil or placebo. If blood pressure is between 90 - 95 mmHg systolic, then dismiss on 1 (5 mg) tab of Tadalafil.
At 2 weeks (± 5 days) if blood pressure is\> 100 than add 1 (5 mg) tab of Tadalafil to make a total of 3 (5mg) tabs of Tadalafil.
At 4 weeks(± 5 days) if blood pressure is \> 100 add 1 (5 mg) tab to make a total of 4 (5 mg) tablets of Tadalafil.
|
Placebo
Subject received Placebo daily for a total of 12 weeks
Placebo: Placebo tablet. Daily. Placebo tablets made to match appearance of 5mg Tadalafil tablets. Placebo dose varies from 5 mg to 20 mg (1 to 4 tablets) for 12 weeks. If blood pressure is \>95 then subject dismissed from CRU on 2 tabs of placebo. If blood pressure is between 90 - 95 mmHg systolic, then dismiss on 1 (5 mg) tablet of placebo.
At 2 weeks (± 5 days) if blood pressure is\> 100 than add 1 tab of placebo to make a total of 3 tablets of placebo.
At 4 weeks(± 5 days) if blood pressure is \> 100 add 1 (5 mg) tab to make a total of 4 tablets of placebo.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
7
|
|
Overall Study
COMPLETED
|
14
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Tadalafil
Subject received Tadalafil daily for a total of 12 weeks
Tadalafil: Tadalafil 5 mg tablet. Daily. Tadalafil dose varies from 5 mg to 20 mg for 12 weeks. If blood pressure is \>95 then subject dismissed from the Clinical Research Unit (CRU) on 2 (5 mg) tabs of tadalafil or placebo. If blood pressure is between 90 - 95 mmHg systolic, then dismiss on 1 (5 mg) tab of Tadalafil.
At 2 weeks (± 5 days) if blood pressure is\> 100 than add 1 (5 mg) tab of Tadalafil to make a total of 3 (5mg) tabs of Tadalafil.
At 4 weeks(± 5 days) if blood pressure is \> 100 add 1 (5 mg) tab to make a total of 4 (5 mg) tablets of Tadalafil.
|
Placebo
Subject received Placebo daily for a total of 12 weeks
Placebo: Placebo tablet. Daily. Placebo tablets made to match appearance of 5mg Tadalafil tablets. Placebo dose varies from 5 mg to 20 mg (1 to 4 tablets) for 12 weeks. If blood pressure is \>95 then subject dismissed from CRU on 2 tabs of placebo. If blood pressure is between 90 - 95 mmHg systolic, then dismiss on 1 (5 mg) tablet of placebo.
At 2 weeks (± 5 days) if blood pressure is\> 100 than add 1 tab of placebo to make a total of 3 tablets of placebo.
At 4 weeks(± 5 days) if blood pressure is \> 100 add 1 (5 mg) tab to make a total of 4 tablets of placebo.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Study to Determine How Cialis Effects the Renal Function in Response to Volume Expansion in Preclinical Diastolic Cardiomyopathy (Aim3)
Baseline characteristics by cohort
| Measure |
Tadalafil
n=15 Participants
Subject received Tadalafil daily for a total of 12 weeks
Tadalafil: Tadalafil 5 mg tablet. Daily. Tadalafil dose varies from 5 mg to 20 mg for 12 weeks. If blood pressure is \>95 then subject dismissed from the Clinical Research Unit (CRU) on 2 (5 mg) tabs of tadalafil or placebo. If blood pressure is between 90 - 95 mmHg systolic, then dismiss on 1 (5 mg) tab of Tadalafil.
At 2 weeks (± 5 days) if blood pressure is\> 100 than add 1 (5 mg) tab of Tadalafil to make a total of 3 (5mg) tabs of Tadalafil.
At 4 weeks(± 5 days) if blood pressure is \> 100 add 1 (5 mg) tab to make a total of 4 (5 mg) tablets of Tadalafil.
|
Placebo
n=7 Participants
Subject received Placebo daily for a total of 12 weeks
Placebo: Placebo tablet. Daily. Placebo tablets made to match appearance of 5mg Tadalafil tablets. Placebo dose varies from 5 mg to 20 mg (1 to 4 tablets) for 12 weeks. If blood pressure is \>95 then subject dismissed from CRU on 2 tabs of placebo. If blood pressure is between 90 - 95 mmHg systolic, then dismiss on 1 (5 mg) tablet of placebo.
At 2 weeks (± 5 days) if blood pressure is\> 100 than add 1 tab of placebo to make a total of 3 tablets of placebo.
At 4 weeks(± 5 days) if blood pressure is \> 100 add 1 (5 mg) tab to make a total of 4 tablets of placebo.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69 years
n=5 Participants
|
77 years
n=7 Participants
|
70 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
7 participants
n=7 Participants
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 weeksChange in total urinary sodium excretion as measured by MEq/min
Outcome measures
| Measure |
Tadalafil
n=14 Participants
Subject received Tadalafil daily for a total of 12 weeks
Tadalafil: Tadalafil 5 mg tablet. Daily. Tadalafil dose varies from 5 mg to 20 mg for 12 weeks. If blood pressure is \>95 then subject dismissed from the Clinical Research Unit (CRU) on 2 (5 mg) tabs of tadalafil or placebo. If blood pressure is between 90 - 95 mmHg systolic, then dismiss on 1 (5 mg) tab of Tadalafil.
At 2 weeks (± 5 days) if blood pressure is\> 100 than add 1 (5 mg) tab of Tadalafil to make a total of 3 (5mg) tabs of Tadalafil.
At 4 weeks(± 5 days) if blood pressure is \> 100 add 1 (5 mg) tab to make a total of 4 (5 mg) tablets of Tadalafil.
|
Placebo
n=7 Participants
Subject received Placebo daily for a total of 12 weeks
Placebo: Placebo tablet. Daily. Placebo tablets made to match appearance of 5mg Tadalafil tablets. Placebo dose varies from 5 mg to 20 mg (1 to 4 tablets) for 12 weeks. If blood pressure is \>95 then subject dismissed from CRU on 2 tabs of placebo. If blood pressure is between 90 - 95 mmHg systolic, then dismiss on 1 (5 mg) tablet of placebo.
At 2 weeks (± 5 days) if blood pressure is\> 100 than add 1 tab of placebo to make a total of 3 tablets of placebo.
At 4 weeks(± 5 days) if blood pressure is \> 100 add 1 (5 mg) tab to make a total of 4 tablets of placebo.
|
|---|---|---|
|
Change in Urinary Sodium Excretion
|
74.43 MEq/min
Interval 33.3 to 102.4
|
29.11 MEq/min
Interval -17.0 to 46.1
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksChange in total GFR as measured by ml/1.72m2
Outcome measures
| Measure |
Tadalafil
n=14 Participants
Subject received Tadalafil daily for a total of 12 weeks
Tadalafil: Tadalafil 5 mg tablet. Daily. Tadalafil dose varies from 5 mg to 20 mg for 12 weeks. If blood pressure is \>95 then subject dismissed from the Clinical Research Unit (CRU) on 2 (5 mg) tabs of tadalafil or placebo. If blood pressure is between 90 - 95 mmHg systolic, then dismiss on 1 (5 mg) tab of Tadalafil.
At 2 weeks (± 5 days) if blood pressure is\> 100 than add 1 (5 mg) tab of Tadalafil to make a total of 3 (5mg) tabs of Tadalafil.
At 4 weeks(± 5 days) if blood pressure is \> 100 add 1 (5 mg) tab to make a total of 4 (5 mg) tablets of Tadalafil.
|
Placebo
n=7 Participants
Subject received Placebo daily for a total of 12 weeks
Placebo: Placebo tablet. Daily. Placebo tablets made to match appearance of 5mg Tadalafil tablets. Placebo dose varies from 5 mg to 20 mg (1 to 4 tablets) for 12 weeks. If blood pressure is \>95 then subject dismissed from CRU on 2 tabs of placebo. If blood pressure is between 90 - 95 mmHg systolic, then dismiss on 1 (5 mg) tablet of placebo.
At 2 weeks (± 5 days) if blood pressure is\> 100 than add 1 tab of placebo to make a total of 3 tablets of placebo.
At 4 weeks(± 5 days) if blood pressure is \> 100 add 1 (5 mg) tab to make a total of 4 tablets of placebo.
|
|---|---|---|
|
Change in Glomerular Filtration Rate (GFR)
|
7 ml/1.72 m2
Interval -1.0 to 26.3
|
-9 ml/1.72 m2
Interval -24.5 to 2.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 12 weeksChange in total urinary cGMP hormone excretion as measured by pmol/min
Outcome measures
| Measure |
Tadalafil
n=14 Participants
Subject received Tadalafil daily for a total of 12 weeks
Tadalafil: Tadalafil 5 mg tablet. Daily. Tadalafil dose varies from 5 mg to 20 mg for 12 weeks. If blood pressure is \>95 then subject dismissed from the Clinical Research Unit (CRU) on 2 (5 mg) tabs of tadalafil or placebo. If blood pressure is between 90 - 95 mmHg systolic, then dismiss on 1 (5 mg) tab of Tadalafil.
At 2 weeks (± 5 days) if blood pressure is\> 100 than add 1 (5 mg) tab of Tadalafil to make a total of 3 (5mg) tabs of Tadalafil.
At 4 weeks(± 5 days) if blood pressure is \> 100 add 1 (5 mg) tab to make a total of 4 (5 mg) tablets of Tadalafil.
|
Placebo
n=7 Participants
Subject received Placebo daily for a total of 12 weeks
Placebo: Placebo tablet. Daily. Placebo tablets made to match appearance of 5mg Tadalafil tablets. Placebo dose varies from 5 mg to 20 mg (1 to 4 tablets) for 12 weeks. If blood pressure is \>95 then subject dismissed from CRU on 2 tabs of placebo. If blood pressure is between 90 - 95 mmHg systolic, then dismiss on 1 (5 mg) tablet of placebo.
At 2 weeks (± 5 days) if blood pressure is\> 100 than add 1 tab of placebo to make a total of 3 tablets of placebo.
At 4 weeks(± 5 days) if blood pressure is \> 100 add 1 (5 mg) tab to make a total of 4 tablets of placebo.
|
|---|---|---|
|
Change in Urinary Cyclic Guanosine 3',5'-Monophosphate (cGMP) Hormone Excretion
|
450 pmol/min
Interval -261.1 to 663.4
|
-130.6 pmol/min
Interval -399.0 to 45.8
|
Adverse Events
Tadalafil
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tadalafil
n=15 participants at risk
Subject received Tadalafil daily for a total of 12 weeks
Tadalafil: Tadalafil 5 mg tablet. Daily. Tadalafil dose varies from 5 mg to 20 mg for 12 weeks. If blood pressure is \>95 then subject dismissed from the Clinical Research Unit (CRU) on 2 (5 mg) tabs of tadalafil or placebo. If blood pressure is between 90 - 95 mmHg systolic, then dismiss on 1 (5 mg) tab of Tadalafil.
At 2 weeks (± 5 days) if blood pressure is\> 100 than add 1 (5 mg) tab of Tadalafil to make a total of 3 (5mg) tabs of Tadalafil.
At 4 weeks(± 5 days) if blood pressure is \> 100 add 1 (5 mg) tab to make a total of 4 (5 mg) tablets of Tadalafil.
|
Placebo
n=7 participants at risk
Subject received Placebo daily for a total of 12 weeks
Placebo: Placebo tablet. Daily. Placebo tablets made to match appearance of 5mg Tadalafil tablets. Placebo dose varies from 5 mg to 20 mg (1 to 4 tablets) for 12 weeks. If blood pressure is \>95 then subject dismissed from CRU on 2 tabs of placebo. If blood pressure is between 90 - 95 mmHg systolic, then dismiss on 1 (5 mg) tablet of placebo.
At 2 weeks (± 5 days) if blood pressure is\> 100 than add 1 tab of placebo to make a total of 3 tablets of placebo.
At 4 weeks(± 5 days) if blood pressure is \> 100 add 1 (5 mg) tab to make a total of 4 tablets of placebo.
|
|---|---|---|
|
Cardiac disorders
Myocardial Infarction
|
6.7%
1/15 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 13 weeks.
|
0.00%
0/7 • Adverse Events were collected from baseline to end of study, approximately 13 weeks.
|
Other adverse events
| Measure |
Tadalafil
n=15 participants at risk
Subject received Tadalafil daily for a total of 12 weeks
Tadalafil: Tadalafil 5 mg tablet. Daily. Tadalafil dose varies from 5 mg to 20 mg for 12 weeks. If blood pressure is \>95 then subject dismissed from the Clinical Research Unit (CRU) on 2 (5 mg) tabs of tadalafil or placebo. If blood pressure is between 90 - 95 mmHg systolic, then dismiss on 1 (5 mg) tab of Tadalafil.
At 2 weeks (± 5 days) if blood pressure is\> 100 than add 1 (5 mg) tab of Tadalafil to make a total of 3 (5mg) tabs of Tadalafil.
At 4 weeks(± 5 days) if blood pressure is \> 100 add 1 (5 mg) tab to make a total of 4 (5 mg) tablets of Tadalafil.
|
Placebo
n=7 participants at risk
Subject received Placebo daily for a total of 12 weeks
Placebo: Placebo tablet. Daily. Placebo tablets made to match appearance of 5mg Tadalafil tablets. Placebo dose varies from 5 mg to 20 mg (1 to 4 tablets) for 12 weeks. If blood pressure is \>95 then subject dismissed from CRU on 2 tabs of placebo. If blood pressure is between 90 - 95 mmHg systolic, then dismiss on 1 (5 mg) tablet of placebo.
At 2 weeks (± 5 days) if blood pressure is\> 100 than add 1 tab of placebo to make a total of 3 tablets of placebo.
At 4 weeks(± 5 days) if blood pressure is \> 100 add 1 (5 mg) tab to make a total of 4 tablets of placebo.
|
|---|---|---|
|
Nervous system disorders
Lightheadness
|
6.7%
1/15 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 13 weeks.
|
0.00%
0/7 • Adverse Events were collected from baseline to end of study, approximately 13 weeks.
|
|
Renal and urinary disorders
Hematuria
|
6.7%
1/15 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 13 weeks.
|
0.00%
0/7 • Adverse Events were collected from baseline to end of study, approximately 13 weeks.
|
|
Gastrointestinal disorders
Diarrhea
|
6.7%
1/15 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 13 weeks.
|
0.00%
0/7 • Adverse Events were collected from baseline to end of study, approximately 13 weeks.
|
|
Gastrointestinal disorders
Acid Reflux
|
0.00%
0/15 • Adverse Events were collected from baseline to end of study, approximately 13 weeks.
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 13 weeks.
|
|
Renal and urinary disorders
Urinary retention
|
6.7%
1/15 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 13 weeks.
|
0.00%
0/7 • Adverse Events were collected from baseline to end of study, approximately 13 weeks.
|
|
Gastrointestinal disorders
Small Bowel Obstruction
|
6.7%
1/15 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 13 weeks.
|
0.00%
0/7 • Adverse Events were collected from baseline to end of study, approximately 13 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Drainage
|
6.7%
1/15 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 13 weeks.
|
0.00%
0/7 • Adverse Events were collected from baseline to end of study, approximately 13 weeks.
|
|
Cardiac disorders
Chest pain
|
6.7%
1/15 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 13 weeks.
|
0.00%
0/7 • Adverse Events were collected from baseline to end of study, approximately 13 weeks.
|
|
Cardiac disorders
Hypertension
|
6.7%
1/15 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 13 weeks.
|
0.00%
0/7 • Adverse Events were collected from baseline to end of study, approximately 13 weeks.
|
|
Musculoskeletal and connective tissue disorders
Leg Pain
|
6.7%
1/15 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 13 weeks.
|
0.00%
0/7 • Adverse Events were collected from baseline to end of study, approximately 13 weeks.
|
|
General disorders
Fever
|
6.7%
1/15 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 13 weeks.
|
0.00%
0/7 • Adverse Events were collected from baseline to end of study, approximately 13 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place